Summaries of risk management plans
Johdanto (Summaries of risk management plans)
A (Summaries of risk management plans)
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Abacavir Accord (abacavir) RMP v.7.0 public summary 10.3.2021 (pdf)
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Abacavir/Lamivudine Accord (abacavir and lamivudine) RMP v.4.0 public summary 16.2.2021 (pdf)
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Abacavir/Lamivudine Stada (abacavir and lamivudine) (pdf)
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Abasaglar (insulin glargine) (pdf)
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Abirateron Medical Valley (abiraterone) RMP v.3.0 public summary 29.1.2024 (pdf)
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Abiraterone ratiopharm (abiraterone) RMP v.1.2 public summary 10.3.2022 (pdf)
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Abiraterone STADA (abiraterone) RMP v.0.2 public summary 1.3.2021 (pdf)
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Absenor (sodium valproate) RMP v.2.0 public summary 25.4.2024 (pdf)
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Abstral (fentanyl) (pdf)
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Acarizax (dermatophagoides farinae, dermatophagoides pteronyssinus) (pdf)
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Aciclovir Accord (aciclovir) RMP v1.1 public summary 17.7.2019 (pdf)
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Actilyse (alteplase) RMP v.11.0 public summary 18.8.2023 (pdf)
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Addaven (concentrate for Solution for Infusion) RMP v.8.1 public summary 22.2.2021 (pdf)
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Adempas (riociguat) (pdf)
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Albuman (human albumin) (pdf)
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Albumin Baxalta (albumin) RMP v.3.1 public summary 24.1.2020 (pdf)
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Alburex (human albumin) (pdf)
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Alendronat ratiopharm (alendronic acid) (pdf)
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Alfuzosin hydrochloride Orion (alfuzosin) (pdf)
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Allopurinol Accord (allopurinol) RMP v.1.1 public summary 25.1.2019 (pdf)
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Allopurinol Orion (allopurinol) RMP v.3.2 public summary 22.5.2018 (pdf)
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Ambrisentan Accord (ambrisentan) (pdf)
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Amlodipin Accord (amlodipine) RMP v.3.0 public summary 23.1.2020 (pdf)
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Amlodipine/Valsartan/Hydrochlorothiazide Krka (amlodipine, valsartan and hydrochlorothiazide) RMP v.0.2 public summary 26.7.2018 (pdf)
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Amlodipin/Valsartan Krka (amlodipine and valsartan) RMP v.2.2 public summary 16.7.2020 (pdf)
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Amorion Comp (amoxicillin and clavulanic acid) RMP v.2.0 public summary 30.7.2021 (pdf)
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Ampicillin STADA Nordic (ampicillin) RMP v.0.2 public summary 15.2.2024 (pdf)
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Ampres (chloroprocaine) (pdf)
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Anidulafungin Accord (anidulafungin) RMP v.3.0 public summary 2.12.2022 (pdf)
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Anksilon (buspirone) RMP v.1.0 public summary 17.5.2021 (pdf)
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Apixaban Krka (apixaban) RMP v.0.3 public summary 16.9.2021 (pdf)
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Apixaban Orion (apixaban) RMP v.2.1 public summary 12.12.2024 (pdf)
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Apixaban ratiopharm GmbH (apixaban) RMP v.3.0 public summary 28.9.2022 (pdf)
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Apixaban Stada (apixaban) RMP v.1.1 public summary 5.2.2021 (pdf)
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Apremilast Krka (apremilast) RMP v.0.2 public summary 29.4.2024 (pdf)
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Apremilast ratiopharm (apremilast) RMP v.1.1 public summary 6.12.2023 (pdf)
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Apremilast STADA (apremilast) RMP v.1.2 public summary 11.9.2024 (pdf)
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Aprokam (cefuroxime) RMP v.3.1 public summary 7.11.2022 (pdf)
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Arcoxia (etoricoxib) (pdf)
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Aripiprazol Krka (aripiprazole) RMP v.3.0 public summary 28.12.2017 (pdf)
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Aripiprazol Stada (aripiprazole) (pdf)
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Aripiprazol Stada (aripiprazole oral solution) (pdf)
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Aripiprazole Orion (aripiprazole) (pdf)
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Aripiprazole ratiopharm (aripiprazole) RMP v.5.1 public summary 16.12.2024 (pdf)
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Asmanex Twisthaler (mometasone) RMP v.4.0 public summary 25.8.2021 (pdf)
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Astarior (atorvastatin and perindopril) (pdf)
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Atomoxetine Accord (atomoxetine) RMP v.1.1 public summary 12.10-2028 (pdf)
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Atomoxetin Orion (atomoxetine) (pdf)
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Atorvastatin Accord (atorvastatin) RMP v.2.0 public summary 4.7.2016 (pdf) (pdf)
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Atorvastatin Pfizer (atorvastatin) (pdf)
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Atorvastatin Teva (atorvastatin) RMP v.1.2 public summary 30.10.2023 (pdf)
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Atosiban Accord (atosiban) RMP v.3.0 public summary 18.4.2024 (pdf)
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Atosiban Ever Pharma (atosiban) (pdf)
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Atropin Abboxia (atropine) RMP v.2.0 public summary 26.2.2024 (pdf)
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Atropine Accord (atropine) RMP v.1.1 public summary 23.12.2019 (pdf)
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Attadex (dexamphetamine) RMP v.1.1 public summary 10.8.2023 (pdf)
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Avelox (moxifloxacin (pdf)
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Avodart (dutasteride) RMP v.8.2 public summary 26.10.2017 (pdf)
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Axitinib STADA (axitinib) RMP v.1.0 public summary 21.7.2021 (pdf)
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Azeflone (azelastine hydrochloride and fluticasone propionate) RMP v.0.2 public summary 2.3.2023 (pdf)
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Azacitidine Stada (azacitidine) (pdf)
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Azithromycin Krka (azithromycin) RMP v.1.2 public summary 6.12.2013 (pdf)
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Azotorion (azithromycin) (pdf)
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Azyter (azithromycin) (pdf)
B (Summaries of risk management plans)
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Bartal (acetylsalicylic acid) RMP v.2.0 public summary 3.3.2021 (pdf)
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Bendamustine Accord (bendamustine) RMP v.10.0 public summary 1.10.2021 (pdf)
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Bendamustine Fresenius Kabi (bendamustine) (pdf)
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Benelyte (solution for infusion) RMP v.3.1 public summary 24.1.2020 (pdf)
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Benzylpenicillin Fresenius Kabi (benzylpenicillin sodium) RMP v.0.1 public summary 17.8.2022 (pdf)
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Berinert (human C1 esterase inhibitor) (pdf)
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Betaklav (amoxicillin and clavulanic acid) RMP v.2.1 public summary 20.11.2020 (pdf)
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Betaserc (betahistine) (pdf)
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Bicalutamide Accord (bicalutamide) RMP v.1.0 public summary 24.7.2018 (pdf)
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Bimatix (imatinib) RMP v.0.3 public summary 20.9.2024 (pdf)
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Bimatoprost Stada (bimatoprost) (pdf)
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Bimatoprost/Timolol Stada (bimatoprost and timolol) (solution in single-dose container) RMP v.0.3 public summary 24.2.2021 (pdf)
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Biphozyl (solution for haemodialysis/haemofiltration) (pdf)
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Biquetan (quetiapine) (pdf)
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Bisolaclar (acetylcysteine) (pdf)
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Bisoprolol Accord (bisoprolol) RMP v.3.0 public summary 16.1.2020 (pdf)
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Bisoprolol Krka (bisoprolol) RMP v.1.2 public summary 18.9.2013 (pdf)
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Bleomycin Accord (bleomycin) RMP v.3.0 public summary 24.3.2022 (pdf)
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Boostrix (booster vaccination against diphtheria, tetanus and pertussis) RMP v.7.0 public summary 14.2.2020 (pdf)
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Boostrix Polio (booster vaccination against diphtheria, tetanus, poliomyelitis and pertussis) RMP v.7.0 public summary 14.2.2020 (pdf)
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Bortezomib Baxter (bortezomib) RMP v.0.2 public summary 24.8.2021 (pdf)
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Bortezomib EVER Pharma (bortezomib) RMP v.0.3 public summary 15.7.2021 (pdf)
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Bortezomib Krka (bortezomib) RMP v.1.0 public summary 14.4.2020 (pdf)
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Bortezomib Medical Valley (bortezomib) RMP v.2.0 public summary 5.5.2020 (pdf)
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Bortezomib Vivanta (bortetsomib) (pdf)
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Bosentan Accord (bosentan) RMP v.6.0 public summary 3.12.2019 (pdf)
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Bosentan Orion (bosentan) RMP v.1.0 public summary 30.7.2019 (pdf)
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Bosutinib STADA (bosutinib) RMP v.1.1 public summary 17.8.2023 (pdf)
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Botox and Vistabel (botulinum toxin type A) RMP v.9.6 public summary 1.2.2023 (pdf)
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Brevibloc (esmolol) RMP v.8.2 public summary 16.12.2024 (pdf)
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Brinzolamide Accord (brinzolamide) RMP v.6.0 public summary 13.5.2022 (pdf)
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Brivaracetam Medical Valley (brivaracetam) RMP v.2.0 public summary 10.1.2025 (pdf)
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Brivaracetam ratiopharm (brivaracetam) RMP v.1.2 publiv summary 9.1.2025 (pdf)
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Brivaracetam STADA (brivaracetam) RMP v.0.4 public summary 6.2.2025 (pdf)
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Briviact (brivaracetam) (pdf)
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Brinzolamide/Brimonidine STADA (brinzolamide and brimonidine) RMP v.1.0 public summary 14.7.2022 (pdf)
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Budesonid Medical Valley (budesonide) RMP v.2.0 public summary 18.1.2023 (pdf)
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Budesonide Teva (budesonide) (pdf)
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Bugvi (paclitaxel) RMP v.1.1 public summary 14.11.2023 (pdf)
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Bupivacaine Accord (bupivacaine) RMP v.3.0 public summary 3.11.2015 (pdf)
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Bupivacaine Spinal Tung Aguettant (bupivacaine) RMP v.0.5 public summary 27.11.2024 (pdf)
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Buprenorphine ratiopharm (buprenorphine) (pdf)
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Buprenorphine Stada (buprenorphine) (pdf)
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Bupropion Accord (bupropion) RMP v.7.0 public summary 24.1.2024 (pdf)
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Bupropion Orion (bupropion) RMP v.3.0 public summary12.11.2024 (pdf)
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Burana powder for oral solution in sachet (ibuprofen) (pdf)
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Burana oral suspension (ibuprofen) (pdf)
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Buscopan (hyoscine butylbromide) (pdf)
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Buvidal (buprenorphine) (pdf)
C (Summaries of risk management plans)
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Cabazitaxel EVER Pharma (cabazitaxel) RMP v.0.2 public summary 29.10.2019 (pdf)
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Cabazitaxel Fresenius Kabi (cabazitaxel) RMP v.0.3 public summary 31.5.2022 (pdf)
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Cabazitaxel Medical Valley (cabazitaxel) RMP v.3.0 public summary 27.10.2021 (pdf)
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Cabozantinib ratiopharm (cabozantinib) RMP v.1.1 public summary 4.4.2025 (pdf)
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Calcichew (calcium carbonate and cholecalciferol) (pdf)
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Calciumfolinat Fresenius Kabi (calcium folinate) (pdf)
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Calciumgluconat B.Braun (calcium gluconate) (pdf)
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Canagliflozin ratiopharm (canagliflozin) RMP v.1.0 public summary 9.4.2024 (pdf)
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Candecam (candesartan and amlodipine) RMP v.2.0 public summary 17.9.2018 (pdf)
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Candesartan STADA (candesartan) RMP v.4.0 public summary 27.11.2024 (pdf)
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Candesartan/Hydrochlorithiazide Orion (candesartan and hydrochlorothiazide) RMP v.3.0 public summary 4.1.2023 (pdf)
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Candesartan/Indapamide Krka (candesartan and indapamide) RMP v.0.1 public summary 25.7.2023 (pdf)
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Canesderm (clotrimazole) RMP v.3.1 public summary 22.5.2020 (pdf)
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Canespor (bifonazole) (pdf)
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Capecitabine Orion (capecitabine) RMP v.3.0 public summary 9.6.2020 (pdf)
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Carboplatin Accord (carboplatin) RMP v1.1 public summary 6.7.2018 (pdf)
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Carmustine Accord (carmustine) RMP v.1.2 public summary 18.6.2021 (pdf)
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Carmustine Accordpharma (carmustine) RMP v.1.0 public summary 24.11.2020 (pdf)
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Carmustine Macure (carmustine) (pdf)
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Cartexan (chondroitin sulfate) (pdf)
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Casodex (bicalutamide) (pdf)
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Caspofungin Orion (caspofungin) RMP v.3.0 public summary 20.10.2022 (pdf)
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Caspofungin Stada (caspofungin) RMP v.1.1 public summary 10.12.2020 (pdf)
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Celebra (celecoxib) RMP v.4.0 public summary 5.10.2017 (pdf)
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Certican (everolimus) RMP v.5.0 public summary 26.11.2021 (pdf)
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Cimzia (TNFα blocker) (pdf)
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Cinacalcet Accord (cinacalcet) RMP v.2.0 public summary 12.12.2023 (pdf)
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Cinacalcet Orion (cinacalcet) RMP v.3.0 public summary 19.7.2024 (pdf)
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Cinacalcet ratiopharm (cinacalcet) RMP v.2.0 public summary 15.7.2020 (pdf)
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Ciprofloxacin Fresenius Kabi (ciprofloxacin) RMP v.0.2 public summary 18.10.2021 (pdf)
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Ciprofloxacin Orion (ciprofloxacin) (pdf)
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Ciqorin (ciclosporin) (pdf)
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Cisatracurium Accord (cisatracurium) RMP v.2.0 public summary 26.3.2024 (pdf)
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Cisatracurium Accordpharma (cisatracurium) RMP v.1.1 public summary 17.5.2021 (pdf)
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Cisplatin Accord (cisplatin) RMP v.4.0 public summary 25.11.2015 (pdf)
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Clarithromycin Krka (clarithromycin) RMP v.1.1 public summary 27.5.2016 (pdf)
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Clindoxyl (Clindamycin and benzoyl peroxide) RMP v.3.0 public summary 7.1.2020 (pdf)
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Clinimix (solution for infusion for parenteral nutrition) RMP v.3.3 public summary 10.5.2023 (pdf)
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Clopidogrel Orion (clopidogrel) RMP v.4.0 public summary 5.5.2025 (pdf)
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Clopidrion (clopidogrel) (pdf)
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Cloxacillin Stragen (cloxacillin) RMP v.1.2 public summary 28.6.2021 (pdf)
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Clozapine Accord (clozapine) RMP v.7.0 public summary 20.4.2023 (pdf)
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Clozapine STADA (clozapine) RMP v.1.2 public summary 15.3.2024 (pdf)
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Cluvot (human factor XIII concentrate) (pdf)
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Cofact (clotting factors II, VII, IX and X) (pdf)
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Cohemin (hydroxocobalamin acetate) RMP v.1.1 public summary 6.3.2024 (pdf)
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Colrefuz (colchicine) RMP v.4.2 public summary 14.9.2022 (pdf)
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Combigan (brimonidine and timolol) RMP v.3.2 public summary 26.9.2024 (pdf)
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Concerta (methylphenidate) RMP v.10.2 public summary 28.7.2023 (pdf)
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Confidex (human prothrombinex complex concentrate) RMP v.3.0 public summary 29.10.2020 (pdf)
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Copaxone (glatiramer acetate) RMP v.8.0 public summary 6.12.2024 (pdf)
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Cortiment (budesonide) RMP v.3.0 public summary 20.12.2019 (pdf)
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Cosopt (dorzolamide and timolol) (pdf)
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Cosyrel (Bisoprolol and perindopril) RMP v.1.1 public summary 7.5.2020 (pdf)
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Cotellic (cobimetinib) (pdf)
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Coveram (perindopril and amlodipine) RMP v.3.0 public summary 2.11.2021 (pdf)
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Coversyl Comp Novum (perindopril and indapamide) RMP v.3.0 public summary 24.6.2022 (pdf)
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Cozaar (losartan) (pdf)
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Creon (pancreatin) (pdf)
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Crestor (rosuvastatin) RMP v.5.0 public summary 15.2.2019 (pdf)
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Cutimum (adapalene and benzoylperoxide) (pdf)
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Cuvitru (human normal immunoglobulin) RMP v.2.0 public summary 24.11.2020 (pdf)
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Cyclophosphamide Accord (cyclophosphamide) RMP v.1.1 public summary 24.9.2020 (pdf)
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Cypretyl (cyproteroneacetate and ethinylestradiol) (pdf)
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Cyramza (ramucirumab) (pdf)
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Cytarabine Accord (cytarabine 100mg/ml solution for injection/infusion) RMP v.2.0 public summary 23.10.2013 (pdf)
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Cytarabine Accord Healthcare (cytarabine 20mg/ml solution for injection/infusion) RMP v.1.0 public summary 19.1.2017 (pdf)
D (Summaries of risk management plans)
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Dabigatran etexilate Krka (dabigatran etexilate) RMP v.0.5 public summary 4.10.2023 (pdf)
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Dabigatran etexilate Stada (dabigatran etexilate) RMP v.1.3 public summary 19.9.2023 (pdf)
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Dabigatran etexilate STADA Nordic (dabigatran etexilate) RMP v.1.3 public summary 19.9.2023 (pdf)
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Dacepton (apomorphine) (pdf)
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Dagraduo (sitagliptin and dapagliflozin) RMP v.0.4 public summary 14.2.2025 (pdf)
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Daivobet (calcipotriol and betamethasone dipropionate) (pdf)
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Dalacin (clindamycin) (pdf)
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Dapagliflozin Krka (dapagliflozin) RMP v.0.4 public summary 24.7.2023 (pdf)
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Daptomycin Accord Healthcare (daptomycin) RMP v.6.0 public summary 25.10.2021 (pdf)
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Daptomycin Accordpharma (daptomycin) RMP v.6.0 public summary 25.10.2021 (pdf)
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Darunavir Accord (darunavir) RMP v.1.0 public summary 25.6.2018 (pdf)
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Darunavir Medical Valley (darunavir) RMP v.1.3 public summary 20.8.2024 (pdf)
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Darunavir Stada (darunavir) (pdf)
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Dasatinib Krka (dasatinib) RMP v.3.0 public summary 15.4.2019 (pdf)
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Deferasirox Stada (deferasirox) (pdf)
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Defitelio (defibrotide) (pdf)
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Deprakine (valproate) RMP v.6.2 public summary 23.7.2021 (pdf)
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Desflurane Baxter (desflurane) RMP v.2.2 public summary 21.7.2023 (pdf)
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Desloratadin Orion (desloratadine) RMP v.2.1 public summary 25.10.2021 (pdf)
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Desloratadine Actavis (desloratadine) (pdf)
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Desmopressin Orion (desmopressin) RMP v.1.2 public summary 15.5.2024 (pdf)
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Desmopressin ratiopharm (desmopressin) RMP v.0.2 public summary 14.3.2022 (pdf)
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Desmopressin STADA (desmopressin) RMP v.0.2 public summary 14.3.2022 (pdf)
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Destamin (desloratadine) (pdf)
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Detremin (cholecalciferol) (pdf)
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Dexacur (dexamethasone) RMP v.2.0 public summary 2.6.2021 (pdf)
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Dexamethasone phosphate Kabi (dexamethasone) RMP v.3.1 public summary 27.10.2020 (pdf)
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Dexdor (dexmedetomidine) (pdf)
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Dexketoprofen Krka (dexketoprofen) RMP v.0.2 public summary 10.9.2018 (pdf)
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Dexmedetomidine B. Braun (dexmedetomidine) (pdf)
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Dexmedetomidine Baxter (dexmedetomidine) RMP v.0.2 public summary 5.11.2020 (pdf)
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Dexmedetomidine Kabi (dexmedetomidine) RMP v.0.1 public summary 18.2.2021 (pdf)
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Diane Nova (cyproterone acetate and ethinylestradiol) (pdf)
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Diazepam Accord (diazepam) (pdf)
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Dicloabak (diclofenac sodium) (pdf)
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Diclofenac STADA (diclofenac) RMP v.1.1 public summary 19.4.2023 (pdf)
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Digoxin Orion (digoxin) (pdf)
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Dienogest Stragen (dienogest) RMP v.1.0 public summary 17.1.2019 (pdf)
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Dimethyl fumarate STADA (dimethyl fumarate) RMP v.1.1 public summary 10.8.2022 (pdf)
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Dimethyl fumarate STADA Nordic (dimethyl fumarate) RMP v.0.3 public summary 19.12.2024 (pdf)
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Dimethyl fumarate Teva GmbH (dimethyl fumarate) RMP v.1.2 public summary 11.10.2024 (pdf)
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Diovan (valsartan) (pdf)
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Ditustin (levodropropizine) RMP v.2.0 public summary 12.5.2023 (pdf)
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Divisun (colecalciferol) (pdf)
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Doneprion (donepezil) (pdf)
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Dopital (mexiletine) RMP v.0.1 public summary 7.6.2021 (pdf)
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Doxorubicin Accord (doxorubicin) RMP v1.0 public summary 23.8.2029 (pdf)
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Droperidol Aguettant (droperidol) RMP v.0.2 public summary 24.1.2024 (pdf)
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Duavive (conjugated oestrogens and bazedoxifene) (pdf)
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Ducressa (dexamethasone and levofloxacin) (pdf)
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Duloxetine Accord (duloxetine) RMP v.6.0 public summary 10.2.2022 (pdf)
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Duloxetine Accordpharma (duloxetine) RMP v.1.1 public summary 25.6.2019 (pdf)
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Duloxetine Krka (duloxetine) RMP v.4.0 public summary 10.11.2020 (pdf)
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Duloxetine Orion (duloxetine) RMP v.2.0 public summary 19.11.2020 (pdf)
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Duloxetine ratiopharm (duloxetine) (pdf)
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Duloxetin Stada (duloxetine) (pdf)
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Duodart (dutasteride and tamsulosin) RMP v.8.2 public summary 26.10.2017 (pdf)
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Duodopa (levodopa and carbidopa) RMP v.11.0 public summary 1.11.2023 (pdf)
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Duokopt (dorzolamide and timolol) (pdf)
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Duonasa (azelastine+fluticasone propionate) RMP v.1.0 public summary 2.9.2021 (pdf)
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Duosol (solution for haemofiltration) (pdf)
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Duphalac fruit (lactulose) (pdf)
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Dutasteride Krka (dutasteride) RMP v.2.0 public summary 14.12.2020 (pdf)
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Dutasteride Medical Valley (dutasteride) RMP v.0.2 public summary 10.5.2019 (pdf)
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Dutasteride ratiopharm (dutasteride) (pdf)
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Dutasteride/Tamsulosin Orion (dutasteride and tamsulosin) (pdf)
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Dutasteride/Tamsulosin ratiopharm (dutasteride and tamsulosin) (pdf)
E (Summaries of risk management plans)
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Edoxaban Krka (edoxaban) RMP v.0.2 public summary 12.3.2024 (pdf)
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Edoxaban ratiopharm (edoxaban) RMP v.1.2 public summary 25.11.2024 (pdf)
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Efedrin Abboxia (ephedrine) RMP v.1.0 public summary 31.10.2023 (pdf)
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Efedrin Unimedic (ephedrine) RMP v.2.0 27.10.2017 (pdf)
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Efexor Depot (venlafaxine) (pdf)
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Efluelda, Efluelda Tetra (tri- and quadrivalent influenza vaccine) RMP v.2.0 public summary 27.6.2024 (pdf)
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Eletriptan Orion (eletriptan) RMP v.2.0 public summary 20.6.2022 (pdf)
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Elidel (pimecrolimus) (pdf)
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Eltrombopag KRKA (eltrombopag) RMP v.0.2 public summary 20.10.2023 (pdf)
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Eltrombopag STADA (eltrombopag) RMP v.0.2 public summary 18.1.2024 (pdf)
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Elvanse (lisdexamfetamine) RMP v.5.0 public summary 1.9.2021 (pdf)
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Elymbus (bimatoprost) RMP v.1.2 public summary 8.3.2023 (pdf)
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Emtenef (efavirenz, emtricitabine and tenofovir) (pdf)
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Emtricitabine/Tenofovir disoproxil Accordpharma (emtricitabine and tenofovir disoproxil) RMP v.4.0 public summary 13.4.2023 (pdf)
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Emtricitabine/Tenofovir disoproxil Krka (emtricitabine and tenofovir disoproxil) RMP v.5.1 public summary 9.6.2023 (pdf)
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Emtricitabine/Tenofovir disoproxil Krka d.d. (emtricitabine and tenofovir disoproxil) RMP v.4.1. public summary 9.6.2023 (pdf)
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Emtricitabine/Tenofovir disoproxil Stada (emtricitabine and tenofovir disoproxil) (pdf)
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Emtricitabine /Tenofovir disoproxil Teva (emtricitabine and tenofovir disoproxil) (pdf)
-
Emtricitabine/Tenofovir disoproxil Tillomed (emtricitabine and tenofovir disoproxil) (pdf)
-
Enalapril/Lercanidipine Krka (enalapril and lercanidipine) RMP v.2.1 public summary 5.10.2016 (pdf)
-
Enstilar (calcipotriol and betamethasone dipropionate) (pdf)
-
Entacapone Orion Pharma (entacapone) (pdf)
-
Entecavir Stada (entecavir) (pdf)
-
Enzalutamide Stada (enzalutamide) RMP v.0.2 public summary 15.5.2024 (pdf)
-
EpiPen (epinephrine) (pdf)
-
Epirubicin Accord (epirubicin) RMP v.5.0 public summary 29.6.2023 (pdf)
-
Eposin (etoposide) (pdf)
-
Eprex (epoetin alfa) (pdf)
-
Equasym Retard (methylphenidate) RMP v.8.3 public summary 24.5.2024 (pdf)
-
Eribulin STADA (eribulin) RMP v.1.0 public summary 15.7.2022 (pdf)
-
Erlotinib Krka (erlotinib) RMP v.1.0 public summary 19.7.2019 (pdf)
-
Erlotinib Stada (erlotinib) (pdf)
-
Ertapenem Fresenius Kabi (ertapenem) (pdf)
-
Escitalopram Krka (escitalopram) (pdf)
-
Escitalopram Lundbeck (escitalopram) (pdf)
-
Escitalopram Orion (escitalopram) RMP v.3.0 public summary 14.10.2021 (pdf)
-
Ethambutol Orion (ethambutol) (pdf)
-
Etoposide Accord (etoposide) RMP v.6.0 public summary 23.1.2020 (pdf)
-
Etoricoxib Krka (etoricoxib) RMP v.2.1 public summary 16.6.2021 (pdf)
-
Etoricoxib Orion (etoricoxib) RMP v.2.0 public summary 22.3.2022 (pdf)
-
Etoricoxib ratiopharm (etoricoxib) (pdf)
-
Etoricoxib Stada (etoricoxib) (pdf)
-
Etraga (azacitidine) RMP v.0.2 public summary 14.12.2021 (pdf)
-
Everolimus Krka (everolimus) RMP v.3.0 public summary 14.12.2017 (pdf)
-
Extraneal (peritoneal dialysis solution) (pdf)
-
Ezetimib Krka (ezetimibe) RMP v.2.0 public summary 15.10.2020 (pdf)
-
Ezetimib Medical Valley (ezetimibe) RMP v.1.0 public summary 15.2.2016 (pdf)
-
Ezetimib Stada (ezetimibe) (pdf)
-
Ezetimibe Accord (ezetimibe) RMP v.6.0 public summary 20.4.2016 (pdf)
-
Ezetimib/Atorvastatin Krka (ezetimibe and atorvastatin) RMP v.0.1 public summary 16.10.2023 (pdf)
-
Ezetrol (ezetimibe) (pdf)
F (Summaries of risk management plans)
-
Faberka (tadalafil) (pdf)
-
Fampridine Stada (fampridine) RMP v.1.2 public summary 5.1.2022 (pdf)
-
Febuxostat Accord (febuxostat) RMP v.1.1 public summary 5.4.2018 (pdf)
-
Febuxostat Medical Valley (febuxostat) RMP v.4.1 public summary 9.5.2023 (pdf)
-
Feiba (Factor VIII Inhibitor Bypassing Activity) (pdf)
-
Femar (letrozole) RMP v.6.0 public summary 22.6.2020 (pdf)
-
Femoston (estradiol and dydrogesterone) (pdf)
-
Fenylefrin Unimedic (phenylephrine) (pdf)
-
Ferulinor (lenalidomide) RMP v.0.3 public summary 14.12.2020 (pdf)
-
Fesoterodine Accord (fesoterodine) RMP v.2.1 public summary 28.5.2022 (pdf)
-
Fesoterodine STADA (fesoterodine) RMP v.0.2 public summary 22.10.2020 (pdf)
-
Fexofenadine ratiopharm (fexophenadine) (pdf)
-
Fibclot (fibrinogen) (pdf)
-
Fingolimod Krka (fingolimod) RMP v.1.1 public summary 2.9.2021 (pdf)
-
Fingolimod Medical Valley (fingolimod) RMP v.8.0 public summary 5.9.2024 (pdf)
-
Fingolimod Orion (fingolimod) RMP v.3.0 public summary 3.2.2025 (pdf)
-
Fingolimod ratiopharm (fingolimod) RMP v.1.2 public summary 30.4.2020 (pdf)
-
Fingolimod STADA (fingolimod) RMP v.1.3 public summary 24.6.2020 (pdf)
-
Finomel and Finomel Perifer (emulsion for infusion) (pdf)
-
Firazyr (icatibant) (pdf)
-
Firekol (roflumilast) RMP v.0.2 public summary 3.3.2023 (pdf)
-
Fixopost (latanoprost and timolol) (pdf)
-
Flecainide Orion (flecainide) RMP v.3.0 public summary 10.2.2022 (pdf)
-
Fluarix Tetra (influenza vaccine [two influenza A virus subtypes and the two influenza B virus]) RMP v.13.0 public summary 3.6.2020 (pdf)
-
Flucloxacillin Orion (flucloxacillin) RMP v.2.0 public summary 9.2.2021 (pdf)
-
Fluconazol ratiopharm (fluconazole) RMP v.1.2 public summary 12.12.2022 (pdf)
-
Fluconazol Vitabalans (fluconazole) RMP v.0.1 public summary 17.6.2020 (pdf)
-
Fludarabin Actavis (fludarabine) (pdf)
-
Fludarabine Accord (fludarabine) RMP v.4.0 public summary 11.4.2023 (pdf)
-
FludeoMAP (fludeoxyglucose (18F)) RMP v.2.0 public summary 19.12.2022 (pdf)
-
Fluorescite (fluorescein sodium) (pdf)
-
Fluorouracil Accord (fluorouracil) RMP v.4.0 public summary 23.8.2019 (pdf)
-
Flurbiprofen STADA (flurbiprofen) RMP v.0.3 public summary 19.6.2023 (pdf)
-
Flusils hunaja-sitruuna (flurbiprofen) RMP v.2.2 public summary 13.7.2021 (pdf)
-
Fluticasone furoate ratiopharm (fluticasone furoate) RMP v.2.0 public summary 17.10.2024 (pdf)
-
Folic Acid Vitabalans (folic acid) (pdf)
-
Forminet (metformin) RMP v.1.2 public summary 27.1.2023 (pdf)
-
Fosaprepitant Accord (fosaprepitant) RMP v.3.0 public summary 30.10.2017 (pdf)
-
Fosastad (alendronate and colecalciferol) (pdf)
-
Fosfomycin Infectopharm (fosfomycin) (pdf)
-
Fosrenol (lanthanum) RMP v.10.0 public summary 11.7.2022 (pdf)
-
Fulvestrant Accord (fulvestrant) RMP v.6.0 public summary 8.3.2024 (pdf)
-
Fulvestrant EVER Pharma (fulvestrant) RMP v.0.3 public summary 19.4.2018 (pdf)
-
Fulvestrant STADA Nordic (fulvestrant) RMP v.0.1 public summary 26.4.2023 (pdf)
-
Furosemide Accord (furosemide) RMP v.3.0 public summary 14.10.2019 (pdf)
G (Summaries of risk management plans)
-
Gabapentin Accord (gabapentin) RMP v.2.0 public summary 3.2.2016 (pdf)
-
Gabapentin Actavis (gabapentin) RMP v.2.0 public summary 19.2.2024 (pdf)
-
Gabapentin Orion (gabapentin) RMP v.2.0 public summary 11.5.2022 (pdf)
-
Gabrion (gabapentin) (pdf)
-
Gasterix (lansoprazole) (pdf)
-
Gazyvaro (obinutuzumab) (pdf)
-
Gefitinib Accord (gefitinib) RMP v.1.2 public summary 26.7.2018 (pdf)
-
Gefitinib ratiopharm (gefinitib) (pdf)
-
Gemcitabine Accord (gemcitabine) RMP v.3.0 public summary 10.7.2020 (pdf)
-
Gemkabi (gemcitabine) (pdf)
-
Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide) (pdf)
-
Geloplasma (solution for infusion) (pdf)
-
Giotrif (afatinib) (pdf)
-
Glykopyrroniumbromidi Accord (glycopyrronium bromide) RMP v.5.0 public summary 4.3.2022 (pdf)
H (Summaries of risk management plans)
-
Haemwill (Human plasma coagulation factor VIII, human von Willebrand factor) RMP v.1.0 public summary 11.3.2022 (pdf)
-
Harvoni (ledipasvir and sofosbuvir) (pdf)
-
Hepatect (human Hepatitis B-immunglobulin) (pdf)
-
Histec (cetirizine) RMP v.3.0 public summary 22.4.2021 (pdf)
-
Hydrocortisone Orion (hydrocortisone) RMP v.3.0 public summary 28.7.2020 (pdf)
-
Hydrokortison CCS (hydrocortisone) (pdf)
-
Hydroxyzine Orion (hydroxyzine) (pdf)
I (Summaries of risk management plans)
-
Ibandronate ratiopharm (ibandronic acid) (pdf)
-
Ibandronat Stada (ibandronic acid) (pdf)
-
Ibumax Lysin (ibuprofen lysin) RMP v.0.1 public summary 19.11.2020 (pdf)
-
Ibumax-C (ibuprofen) (pdf)
-
Ibuprofen Accord (ibuprofen) RMP v.5.0 public summary 19.5.2021 (pdf)
-
Ibuprofen B.Braun (ibuprofen) (pdf)
-
Ibuxin-Caps (ibuprofen) RMP v.1.0 public summary 23.3.2022 (pdf)
-
Icatibant Fresenius (icatibant) RMP v. 0.2 public summary 11.10.2021 (pdf)
-
Icatibant Ratiopharm (icatibant) RMP v.1.1 public summary 21.12.2020 (pdf)
-
Icatibant Stada (icatibant) RMP v. 0.2 public summary 17.2.2021 (pdf)
-
Idarubicin Accord (idarubicin) RMP v.2.0 public summary 20.7.2015 (pdf)
-
Ikervis (ciclosporin) (pdf)
-
Imatinib Fresenius Kabi (pdf)
-
Imatinib Krka (imatinib) RMP v.4.3 public summary 22.7.2022 (pdf)
-
Imatinib Orion (imatinib) RMP v.3.2 public summary 4.6.2021 (pdf)
-
Imatinib STADA (imatinib) RMP v.1.2 public summary 10.3.2021 (pdf)
-
Imbruvica (ibrutinib) (pdf)
-
Imodium (loperamide) (pdf)
-
Imodium Plus (loperamide and simethicone) (pdf)
-
Inandex (dexamethasone) RMP v.1.1 public summary 3.5.2024 (pdf)
-
Incruse (umeclidinium bromide) (pdf)
-
Infanrix-IPV (vaccine for diphtheria, tetanus and pertussis (DTP) and polio) RMP v.1.0 public summary 18.2.2021 (pdf)
-
Influvac (influenza vaccine) (pdf)
-
Injexate (methotrexate) RMP v.8.0 public summary 28.2.2022 (pdf)
-
Innohep (tinzaparin sodium) (pdf)
-
Inspiolto Respimat (tiotropium and olodaterol) RMP v.5.0 public summary 18.5.2022 (pdf)
-
Inspra (eplerenone) RMP v.2.1 public summary 2.2.2017 (pdf)
-
Instanyl (fentanyl) RMP v.19.6 public summary 16.3.2020 (pdf)
-
Intratect (human normal immunoglobulin - IVIg) (pdf)
-
Ipratropium bromide/Salbutamol Neutec (ipratropium bromide and salbutamol) RMP v.0.3 public summary 26.4.2023 (pdf)
-
Irinotecan Accord (irinotecan) RMP v.4.2 public summary 28.5.2025 (pdf)
-
Isotretinoin Actavis (isotretinoin) RMP v.9.4 public summary 8.10.2024 (pdf)
-
Itulazax (birch pollen extract) (pdf)
-
Ivermectin Medical Valley (ivermectin) RMP v.1.0 public summary 28.4.2021 (pdf)
-
Ivermectine ratiopharm (ivermectine) RMP v.2.0 public summary 4.8.2023 (pdf)
-
Ivermectin STADA (ivermectin) RMP v.1.0 public summary 20.10.2021 (pdf)
J (Summaries of risk management plans)
K (Summaries of risk management plans)
-
Kadcyla (trastuzumab) (pdf)
-
Kalii chloridum/Glucosum B. Braun (potassiumchloride and glucose) (pdf)
-
Ketipinor (quetiapine) RMP v.2.0 public summary 25.11.2020 (pdf)
-
Ketorolac Macure (ketorolac trometamol) (pdf)
-
Ketosteril (amino acids) RMP v.0.1 public summaru 5.3.2020 (pdf)
-
Kevesy (levetiracetam) RMP v.2.2 public summary 10.1.2023 (pdf)
-
Kidtrayze (concentrate for solution for infusion) RMP v.0.1 public summary 16.9.2021 (pdf)
-
Klexane (enoxaparin) (pdf)
-
Kovaltry (octocog alfa) (pdf)
-
Kyleena (levonorgestrel) RMP v.9.1 public summary 1.9.2023 (pdf)
L (Summaries of risk management plans)
-
Lacosamide Fresenius Kabi (lacosamide) RMP v.0.2 public summary 21.4.2022 (pdf)
-
Lacosamide Medical Valley (lacosamide) RMP v.1.2 public summary 7.3.2023 (pdf)
-
Lamictal (lamotrigine) RMP v.2.1 public summary 16.8.2022 (pdf)
-
Latanoprost Pfizer (latanoprost) RMP v.5.0 public summary 2.2.2017 (pdf)
-
Latanoprost STADA (latanoprost) RMP v.0.2 public summary 3.4.2024 (pdf)
-
Lecrolyn (sodium cromoglicate) RMP v.2.0 public summary 17.6.2019 (pdf)
-
Leflunomide Orion (leflunomide) RMP v.1.1 public summary 6.7.2022 (pdf)
-
Leflunomide Stada (leflunomide) (pdf)
-
Lemilvo (aripiprazole) (pdf)
-
Lenalidomide Fresenius Kabi (lenalidomide) RMP v.1.1 public summary 3.3.2022 (pdf)
-
Lenalidomide Orion (lenalidomide) RMP v.2.1 public summary 1.3.2024 (pdf)
-
Lenalidomide ratiopharm (lenalidomide) RMP v.4.3 public summary 13.8.2024 (pdf)
-
Lenalidomide STADA (lenalidomide) RMP v.4.1 public summary 29.9.2020 (pdf)
-
Lercanidipin Orion (lerkadipine) (pdf)
-
Lercanidipine hydrochloride Accord (lercanidipine) RMP v.1.0 public summary 22.5.2020 (pdf)
-
Lescol (fluvastatin) (pdf)
-
Letrozol Accord (letrozole) RMP v.2.0 public summary 5.4.2022 (pdf)
-
Letrozol Orion (letrozole) (pdf)
-
Levocetirizin Orion (levocetirizine) (pdf)
-
Levocetirizin Stada (levocetirizine) (pdf)
-
Levofloxacin Fresenius Kabi (levofloxacin) RMP v.0.0 public summary 20.1.2021 (pdf)
-
Levofloxacin Krka (levofloxacin) RMP v.2.1 public summary 10.6.2020 (pdf)
-
Levofloxacin Orion (levofloxacin) (pdf)
-
Levolac (lactulose) RMP v.2.0 public summary 12.7.2022 (pdf)
-
Levomepromazine Orion (levomepromazine) RMP v.2.1 public summary 16.11.2022 (pdf)
-
Levosimendan Fresenius Kabi (levosimendan) RMP v.0.2 public summary 31.3.2021 (pdf)
-
Levosimendan STADA (levosimendan) RMP v.1.1 public summary 26.6.2023 (pdf)
-
Levothyroxine Orion (levothyroxine) RMP v.1 public summary 23.11.2018 (pdf)
-
Lidokain Aguettant (lidocaine) (pdf)
-
Lidocaine Orion (lidocaine) (pdf)
-
Lifemin (lisdexamfetamine) RMP v.0.4 public summary 11.11.2022 (pdf)
-
Linagliptin STADA (linagliptin) RMP v.1.0 public summary 9.1.2020 (pdf)
-
Linatera (Drospirenone and ethinylestradiol) (pdf)
-
Linezolid Accord (linetsolid, 2 mg/ml, solution for infusion) RMP v.2.0 public summary 5.5.2015 (pdf)
-
Linezolid Krka (linezolid) RMP v.1.1 public summary 29.6.2015 (pdf)
-
Lezolid Orion (linezolid) (pdf)
-
Liofora (Drospirenone and ethinylestradiol) (pdf)
-
Lipanthyl Penta (fenofibrate) (pdf)
-
Lipistad (atorvastatin) (pdf)
-
Lipitor (atorvastatin) (pdf)
-
Lipoplus (intravenous infusion) (pdf)
-
Liporion (atorvastatin) (pdf)
-
Lisinopril/Hydrochlorothiazide Orion (lisinopril and hydrochlorothiazide) (pdf)
-
Livial (tibolone) (pdf)
-
Lopinavir/Ritonavir Accord (lopinavir and ritonavir) RMP v.4.0 public summary 8.8.2024 (pdf)
-
Loratadine Accord (loratadine) RMP v.1.1 public summary 11.3.2021 (pdf)
-
Lorazepam Macure (lorazepam) (pdf)
-
Lorazepam Orion (lorazepam) RMP v.1.0 public summary 14.6.2021 (pdf)
-
Losarion (losartan) RMP v.2.0 public summary 7.10.2024 (pdf)
-
Losartan Medical Valley (losartan) RMP v.7.0 public summary 1.3.2016 (pdf)
-
Losartan STADA (losartan) RMP v.1.0 public summary 19.8.2023 (pdf)
-
Losartan/Hydrochlorothiazide STADA (losartan and hydrochlorothiazide) RMP v.1.2 public summary 25.10.2022 (pdf)
-
Losatrix (losartan) (pdf)
-
Losec (omeprazole) (pdf)
-
Lurasidone Accord (lurasidone) RMP v.0.3 public summary 28.2.2024 (pdf)
-
Lutinus (progesterone) (pdf)
-
Lynparza (olaparib) (pdf)
M (Summaries of risk management plans)
-
Makrogoli Orion (macrogol 4000) (pdf)
-
Medipekt (bromhexine) (pdf)
-
Meditus (acetylcysteine) RMP v.2.0 public summary 27.1.2022 (pdf)
-
Melatonin Orion (melatonin) RMP v.2.1 public summary 27.2.2024 (pdf)
-
Melatonin Vitabalans (melatonin) (pdf)
-
Melphalan Macure (melphalan) (pdf)
-
Memantine ratiopharm GmbH (memantine) RMP v.1.0 public summary 20.5.2022 (pdf)
-
Memantin Stada (memantine) (pdf)
-
Menopur (menotrophin) (pdf)
-
Menovag (estradiol hemihydrate) (pdf)
-
Mercaptopurin Orion (mercaptopurine) (pdf)
-
Meropenem Medical Valley (meropenem) RMP v.0.2 public summary 5.5.2021 (pdf)
-
Metadon Abcur (methadone) (pdf)
-
Metadon Nordic Drugs (methadone) (pdf)
-
Metformin Accord (metformin film-coated tablets) RMP v.1.0 7.5.2020 (pdf)
-
Metformin Accord (metformin prolonged release tablets 500 mg) RMP v.3.0 public summary 14.7.2016 (pdf)
-
Metformin Accord (metformin prolonged release tablets 750 and 1000 mg) RMP v.1.0 public summary 18.7.2019 (pdf)
-
Metformin Medical Valley (metformin) RMP v.1.0 public summary 5.6.2023 (pdf)
-
Metformin ratiopharm (metformin) RMP v.1.0 public summary 8.3.2021 (pdf)
-
Metformin STADA (metformin) RMP v.1.2 public summary 1.8.2022 (pdf)
-
Methotrexat Accord i.v. (methotrexate) RMP v.5.0 public summary 3.11.2021 (pdf)
-
Methotrexat Accord p.o. (methotrexate) RMP v.10.0 public summary 2.9.2020 (pdf)
-
Methotrexate Afortas (methotrexate) RMP v.0.2 public summary 3.6.2024 (pdf)
-
Methotrexate Orion (methotrexate) RMP v.3.1 public summary 4.6.2020 (pdf)
-
Methylphenidate Actavis (methylphenidate) (pdf)
-
Methylphenidate Orion (methylphenidate) RMP v.4.0 public summary 20.7.2023 (pdf)
-
Methylphenidate STADA (methylphenidate) RMP v.1.1 public summary 21.11.2019 (pdf)
-
Methylprednisolone Orion (methylprednisolone) RMP v.3.0 public summary 8.5.2020 (pdf)
-
Metoclopramide Accord (metoclopramide) RMP v.3.0 12.4.2024 (pdf)
-
Metoclopramide Orion (metoclopramide) RMP v.2.0 public summary 23.9.2021 (pdf)
-
Metopocor (metoprolol) (pdf)
-
Metoprolol Krka (metoprolol) RMP v.1.3 public summary 28.8.2015 (pdf)
-
Midazolam Accordpharma (midazolam) RMP v.1.2 public summary 15.5.2020 (pdf)
-
Midazolam Medical Valley (midazolam) RMP v.2.3 public summary 9.11.2024 (pdf)
-
Miglustat Accord (miglustat) RMP v.0.2 public summary 24.11.2015 (pdf)
-
Milnocor (milrinone) (pdf)
-
Minirin (desmopressin) (pdf)
-
Mirabegron ratiopharm (mirabegron) RMP v.0.2 public summary 21.3.2024 (pdf)
-
Mirabegron STADA (mirabegron) RMP v.0.3 public summary 19.6.2024 (pdf)
-
Mirena (levonogestrel) RMP v.1.2 public summary 5.3.2020 (pdf)
-
Mirtazapin Orion (mirtazapine) (pdf)
-
Mirtazapin Teva (mirtazapine) RMP v.1.1 public summary 9.9.2022 (pdf)
-
Mitomycin Accord (mitomycin) RMP v.3.0 public summary 19.1.2023 (pdf)
-
Modafinil Orion (modafinil) RMP v.3.1 public summary 11.10.2023 (pdf)
-
Momesonex (mometasone) (pdf)
-
Mometasone Actavis (mometasone) (pdf)
-
Mometasone Stada (mometasone) (pdf)
-
Monopex (dexamethasone) RMP v.1.1. public summary 16.11.2021 (pdf)
-
Monoprost (latanoprost) RMP v.4.0 public summary 14.12.2020 (pdf)
-
Morphine Orion (morphine) (pdf)
-
Morphine Unimedic (morphine) (pdf)
-
Moventig (naloxegol) (pdf)
-
Movicol Junior Plain (macrogol 3350) (pdf)
-
Moxifloxacin Fresenius Kabi (moxifloxacin) RMP v.5.1 public summary 16.6.2021 (pdf)
-
Moxifloxacin Krka (moxifloxacin) RMP v.4.2 public summary 9.3.2022 (pdf)
-
Moxifloxacin Orion (moxifloxacin) (pdf)
-
Mucoratio (acetylcysteine) RMP v.3.0 public summary 12.9.2022 (pdf)
-
Mydrane (tropicamide, phenylephrine and lidocaine) RMP v.4.0 public summary 30.1.2020 (pdf)
-
Myfortic (mycophenolic acid) RMP v.3.0 public summary 23.10.2025 (pdf)
N (Summaries of risk management plans)
-
Naloxone Accord (naloxone) RMP v.1.3 public summary 31.10.2022 (pdf)
-
Naltrexon Accord (naltrexone) RMP v.2.0 public summary 9.5.2014 (pdf)
-
Naproxen Accord (naproxen) RMP v1.1 public summary 29.9.2022 (pdf)
-
Naproxen Krka (naproxen) RMP v.2.1 public summary 7.7.2022 (pdf)
-
Naproxen Orion (naproxen) (pdf)
-
Nasacort (triamcinolone acetonide) (pdf)
-
Nasment (xylometazoline) RMP v.4.0 public summary 13.11.2020 (pdf)
-
Nasofan (fluticasone propionate) (pdf)
-
Nasonex (mometasone) RMP v.4.0 public summary 25.8.2021 (pdf)
-
Natriumklorid Abboxia (sodium chloride) RMP v.1.0 public summary 9.12.2022 (pdf)
-
Nebido (testosterone undecanoate) (pdf)
-
Nebivolol Accord (nebivolol) RMP v.1.0 public summary 25.3.2020 (pdf)
-
Neofordex (dexamethasone) (pdf)
-
Neotigason (acitretin) RMP v.6.1 public summary 7.6.2024 (pdf)
-
Neupogen (filgrastim) RMP v.4.0 public summary 4.8.2017 (pdf)
-
Nexium (esomeprazole) (pdf)
-
Nexplanon (etonogestrel) (pdf)
-
Nicorette (nicotine) (pdf)
-
Nicotinell [oral forms] (nicotine) (pdf)
-
Nicotinell Mint [oromucosal spray] (nicotine) RMP v.0.1 public summary 8.2.2023 (pdf)
-
Nilotinib Stada (nilotinib) RMP v.0.3 public summary 2.4.2024 (pdf)
-
Nintedanib ratiopharm (nintedanib) RMP v.0.3 public summary 20.12.2023 (pdf)
-
Nintedanib STADA (nintedanib) RMP v.0.5 public summary 1.11.2023 (pdf)
-
Nitrazepam Accord (nitrazepam) RMP v.2.0 public summary 24.11.2015 (pdf)
-
Nomigrin (sumatriptan and naproxen) RMP v.1.1 public summary 3.1.2022 (pdf)
-
Noradrenalin Fresenius Kabi (noradrenaline) RMP v.1.0 14.8.2020 (pdf)
-
Noradrenalin Laboratoire Aguettant (noradrenalin) RMP v.2.2 public summary 19.8.2022 (pdf)
-
Norspan (bubrenorphine) RMP v.6.4 public summary 3.6.2025 (pdf)
-
Novantrone (mitoxantrone) (pdf)
-
Nucala (mepolizumab) (pdf)
-
Numeta (parenteral nutrition) (pdf)
-
Nutriflex Lipid (parenteral nutrition) (pdf)
-
Nutriflex Omega (parenteral nutrition) (pdf)
-
Nutriflex Omega perifer (parenteral nutrition) (pdf)
-
Nutryelt (parenteral nutrition) (pdf)
-
NuvaRing (etonogestrel and ethinylestradiol) (pdf)
O (Summaries of risk management plans)
-
Octostim (desmopressin) (pdf)
-
Octreotide ratiopharm (octreotide) RMP v.2.0 public summary 11.4.2023 (pdf)
-
Ocutifex (ketotifen hydrogen fumarate) RMP v.4.1 public summary 26.3.2019 (pdf)
-
Ofev (nintedanib) (pdf)
-
Olanzapine Orion (olanzapine) RMP v.4.0 public summary 2.7.2019 (pdf)
-
Olanzapine ratiopharm (olanzapine) (pdf)
-
Oleo-De3 (cholecalciferol) RMP v.2.1 public summary 7.6.2021 (pdf)
-
Olmesartan Medoxomil Accord (olmesartan) RMP v.4.0 public summary 8.10.2021 (pdf)
-
Olmesartan medoxomil Krka (olmesartan) RMP v.1.3 public summary 3.5.2016 (pdf)
-
Olmesartan medoxomil Stada (olmesartan) (pdf)
-
Olmesartan medoxomil/Amlodipine Krka (olmesartan and amlodipine) RMP v.2.0 public summary 6.6.2019 (pdf)
-
Olmesartan medoxomil/Hydrochlorothiazide Krka (olmesartan and hydrochlorothiazide) RMP v.1.2 public summary 18.3.2016 (pdf)
-
Olmestad Comp (olmesartan and hydrochlorothiazide) (pdf)
-
Omeprazol Orion (Omeprazole) (pdf)
-
Ondansetron Accord (ondansetron) RMP v.3.0 public summary 25.7.2024 (pdf)
-
Ondansetron Accordpharma (ondansetron) RMP v.1.1 public summary 31.8.2019 (pdf)
-
Ondansetron Fresenius Kabi (ondansetron) RMP v.0.2 public summary 7.1.2022 (pdf)
-
Oparta (beclometasone and formoterol) RMP v.0.3 public summary 14.10.2024 (pdf)
-
Orbeos (atorvastatin) (pdf)
-
Oridip (lercanidipine) (pdf)
-
Oriptan (sumatriptan) (pdf)
-
Orisild (sildenafil) RMP v.2 public summary 5.1.2022 (pdf)
-
Orivast (atorvastatin) (pdf)
-
Orudis 2.5% gel (etoprofen) (pdf)
-
Otrivin Comp (ipratropium and xylometazoline) (pdf)
-
Oxaliplatin Accord (oxaliplatin) RMP v.1.2 public summary 6.7.2021 (pdf)
-
Oxcarbazepin Orion (oxcarbazepine) RMP v.4.0 public summary 24.8.2021 (pdf)
-
Oxycodone Abboxia (oxycodone) RMP v.1.0 public summary 9.12.2022 (pdf)
-
Oxycodone/Naloxone Acino (oxycodone and naloxone) (pdf)
-
Oxycodone/Naloxone Krka (oxycodone and naloxone) RMP v.1.1 public summary 19.10.2016 (pdf)
-
Oxycodone/Naloxone Stada (oxycodone and naloxone) RMP v.1.0 public summary 26.10.2021 (pdf)
-
OxyNorm (oxycodone) (pdf)
-
Oxycorion Depot (oxycodone) RMP v.3.0 public summary 5.1.2023 (pdf)
P (Summaries of risk management plans)
-
Pabal (carbetocin) (pdf)
-
Paclitaxel Accord (paclitaxel) RMP v.2.2 public summary 15.9.2023 (pdf)
-
Palandra (drospirenone and ethinylestradiol) (pdf)
-
Paliperidone ratiopharm (paliperidone) RMP v.2.0 public summary 10.12.2020 (pdf)
-
Paliperidone STADA (paliperidone) RMP v.1.0 public summary 8.12.2022 (pdf)
-
Palonosetron Fresenius Kabi (palonosetron) RMP v.1.1 public summary 22.12.2020 (pdf)
-
Palonosetron Macure (palonosetron) (pdf)
-
Palonosetron STADA (palonosetron) (pdf)
-
Paminject (pamidronate) (pdf)
-
Pantoprazol Accord (pantoprazol) RMP v.4.0 public summary 23.1.2020 (pdf)
-
Pantoprazol Orion (pantoprazole) (pdf)
-
Pantoprazole STADA (pantoprazole) (pdf)
-
Para-Caps (paracetamol) (pdf)
-
Paracetamol Accord (paracetamol) RMP v.9.0 public summary 29.11.2019 (pdf)
-
Paracetamol B. Braun (paracetamol) RMP v.5.0 public summary 20.4.2023 (pdf)
-
Paracetamol Baxter Viaflo (paracetamol) RMP v.0.4 public summary 22.2.2021 (pdf)
-
Paracetamol Krka (paracetamol) RMP v.0.1 public summary 18.03.2019 (pdf)
-
Paracetamol/Codeine Accord (paracetamol and codeine) RMP v.1.2 public summary 22.11.2023 (pdf)
-
Paramax (paracetamol) RMP v.1.0 public summary 22.6.2022 (pdf)
-
Paricalcitol Accord (paricalcitol) RMP v.4.0 public summary 24.1.2024 (pdf)
-
Pazopanib Accord (pazopanib) RMP v.2.0 public summary 5.4.2023 (pdf)
-
Pazopanib Stada (pazopanib) RMP v.0.5 public summary 9.12.2021 (pdf)
-
Pegorion (macrogol 4000) (pdf)
-
Pemetrexed Fresenius Kabi (pemetrexed) (pdf)
-
Pemetrexed Stada (pemetrexed) (pdf)
-
Penomax (pivmecillinam) (pdf)
-
Pentasa (mesalazine) RMP v.9.0 public summary 26.8.2020 (pdf)
-
Pentavac (DTaP-IPV/Hib) (pdf)
-
Pentiro (entacapone, levodopa and carbidopa) (pdf)
-
Perindopril Orion (perindopril) (pdf)
-
Perindopril/Amlodipin Krka (perindopril and amlodipine) RMP v.1.1 public summary 24.11.2016 (pdf)
-
Permethrin LMP (permethrin) RMP v.1.1 public summary 21.10.2019 (pdf)
-
Physioneal (peritoneal dialysis solution) (pdf)
-
Picorion (sodium picosulfate) (pdf)
-
Piperacillin/Tazobactam STADA (piperacillin and tazobactam) RMP v.0.4 public summary 20.9.2021 (pdf)
-
Pirfenidone Accord (pirfenidone) RMP v.2.1 public summary 9.9.2024 (pdf)
-
Pirfenidone ratiopharm (pirfenidone) RMP v.1.2 public summary 10.1.2022 (pdf)
-
Pirfenidone STADA (pirfenidone) RMP v.1.3 public summary 22.3.2022 (pdf)
-
Plasmalyte (crystalloid solution for intravenous infusion) (pdf)
-
Plasmalyte Glucos (crystalloid solution with glucose for intravenous infusion) (pdf)
-
Pneumovax (pneumococcal polysaccharide vaccine) (pdf)
-
Pomalidomide STADA (pomalidomide) RMP v.0.3 public summary 15.10.2024 (pdf)
-
Portrazza (necitumumab) (pdf)
-
Posaconazole STADA (posaconazole) (pdf)
-
Posirex Honey-Lemon ja Posirex Mint (amylmetacresol and dichlorobenzyl alcohol) (pdf)
-
Pramipexol STADA (pramipexole) (pdf)
-
Pramipexole Orion (pramipexole) (pdf)
-
Pravorion (pravastatin) (pdf)
-
Praxbind (idarucizumab) (pdf)
-
Pregabalin Krka (pregabalin) RMP v.3.0 public summary 1.6.2022 (pdf)
-
Pregabalin Orion (pregabalin) RMP v.6.0 public summary 12.11.2024 (pdf)
-
Pregabalin Orion Pharma (pregabalin) RMP v.6.0 public summary 12.11.2024 (pdf)
-
Pregabalin Stada (pregabalin) (pdf)
-
Priligy (dapoxetine) RMP v.9.0 public summary 25.2.2021 (pdf)
-
Primovist (gadoxetate) (pdf)
-
Priorix-Tetra (vaccine for measles, mumps, rubella and varicella zoster) RMP v.8.0 public summary 8.4.2024 (pdf)
-
Produodopa (foslevodopa and foscarbidopa) RMP v.2.0 public summary 02.2023 (pdf)
-
Pro-Epanutin (fosphenytoin) RMP v.4.1 public summary 18.6.2020 (pdf)
-
Pronaxen (naproxen) (pdf)
-
Propecia (finasteride) (pdf)
-
Propolipid (propofol) RMP v.0.1 public summary 26.10.2020 (pdf)
-
Propess (dinoprostone) RMP v.3.0 public summary 9.11.2020 (pdf)
-
Proscar (finasteride) (pdf)
-
Prucalopride Stada (prucalopride) (pdf)
-
Pyrvin (pyrvinium) RMP v.1.0 public summary 17.9.2021 (pdf)
Q (Summaries of risk management plans)
-
Quetiapin Krka (quetiapine) RMP v.1.8 public summary 8.11.2016 (pdf)
-
Quetiapine Medical Valley (quetiapine) RMP v.1.2 public summary 1.2.2021 (pdf)
-
Quetiapin Orion (quetiapine fumarate) RMP v.2.0 public summary 25.11.2020 (pdf)
-
Quetiapine Accord (quetiapine, film-coated tablets) RMP v.2.0 public summary 24.12.2024 (pdf)
-
Quetiapine Accord (quetiapine, prolong release tablets) RMP v.4.0 public summary 6.8.2020 (pdf)
-
Quetiapine Teva (quetiapine) RMP v.4.1 public summary 16.9.2022 (pdf)
R (Summaries of risk management plans)
-
Rabeprazol Krka (rabeprazole) RMP v.1.2 public summary 4.9.2014 (pdf)
-
Rameam (ramipril and amlodipine) RMP v.2.0 public summary 15.1.2021 (pdf)
-
Raplixa (fibrinogen and thrombin) (pdf)
-
Rasagilin Krka (rasagiline) RMP v.1.1 public summary 02.07.2015 (pdf)
-
Rasagilin Stada (rasagiline) (pdf)
-
Rasagilin Stada Arzneimittel AG (rasagiline) (pdf)
-
Rasagiline Accord (rasagiline) RMP v.3.0 public summary 11.8.2015 (pdf)
-
Rasagiline Orion (rasagiline) (pdf)
-
Regiocit (solution for haemofiltration) (pdf)
-
Remodulin (treprostinil) RMP v.7.0 public summary 13.7.2023 (pdf)
-
Rennie Comp (calcium carbonate and magnesium carbonate and alginic acid) RMP v.1.0 public summary 20.1.2022 (pdf)
-
Rennie Orange (calsium carbonate and magnesium subcarbonate) (pdf)
-
Requip Depot (ropinirole) RMP v.3.0 public summary 14.4.2021 (pdf)
-
Resolor (prucalopride) (pdf)
-
Revitelle (bilastine) (pdf)
-
Rezolsta (darunavir and cobicistat) (pdf)
-
Rhophylac (anti RhD immunoglobulin) (pdf)
-
Riastap (human fibrinogen concentrate) (pdf)
-
Risperdal and Risperdal Consta (risperidone) (pdf)
-
Risperidon ratiopharm (risperidone, powder and solvent) RMP v.1.2 public summary 19.8.2020 (pdf)
-
Ritonavir Accord (ritonavir) RMP v.4.0 public summary 13.11.2023 (pdf)
-
Rivaroxaban Krka (rivaroxaban) RMP v.3.1 public summary 22.2.2024 (pdf)
-
Rivaroxaban Orion (rivaroxaban) RMP v.2.0 public summary 8.3.2023 (pdf)
-
Rivaroxaban ratiopharm (rivaroxaban) RMP v.1.1 public summary 4.12.2019 (pdf)
-
Rivaroxaban STADA film-coated tablets (rivaroxaban) RMP v.1.2 public summary 25.7.2022 (pdf)
-
Rivaroxaban STADA capsules (Rivaroxaban) RMP v.1.2 public summary 4.10.2022 (pdf)
-
Rivastigmin ratiopharm (rivastigmine) (pdf)
-
Rivastor (rivastigmine) (pdf)
-
Rocuronium Fresenius Kabi (rocuronium) RMP v.0.1 public summary 8.3.2021 (pdf)
-
Rosamera (rosuvastatin, perindopril and amlodipine) RMP v.0.1 public summary 24.4.2018 (pdf)
-
Rosuvastatin Actavis (rosuvastatin) RMP v.5.0 public summary 16.2.2022 (pdf)
-
Rosuvastatin Krka (rosuvastatin) RMP v.2.1 public summary 25.4.2022 (pdf)
-
Rosuvastatin Orion (rosuvastatin) RMP v.1.0 public summary 10.7.2021 (pdf)
-
Rosuvastatin ratiopharm (rosuvastatin) RMP v.5.0 public summary 16.2.2022 (pdf)
-
Rosuvastatin STADA (rosuvastatin) (pdf)
-
Rosuvastatin Xiromed (rosuvastatin) RMP v.4.0 public summary 10.12.2019 (pdf)
-
Rosuvastatin/Ezetimibe ratiopharm (rosuvastatin and ezemibe) (pdf)
-
Roxiper (rosuvastatin, perindopril and indapamide) RMP v.1.2 public summary 18.7.2018 (pdf)
-
Rymphysia (alpha1-proteinase inhibitor (Human)) RMP v.1.2 public summary 11.10.2022 (pdf)
S (Summaries of risk management plans)
-
Salbutamol Neutec (salbutamol) RMP v.0.3 public summary 17.4.2023 (pdf)
-
Salflumix Easyhaler (salmeterol and fluticasone) RMP v.2.0 public summary 25.11.2020 (pdf)
-
Saxenda (liraglutide) (pdf)
-
Septabene (benzydamine and cetylpyridinium) RMP v.6.0 public summary 27.2.2025 (pdf)
-
Septabene eukalyptus (benzydamine and cetylpyridinium) RMP v.5.1 public summary 28.7.2020 (pdf)
-
Septabene sitruuna & hunaja (benzydamine and cetylpyridinium) RMP v.5.2 public summary 7.5.2021 (pdf)
-
Septabene sitruuna & seljankukka (benzydamine and cetylpyridinium) RMP v.5.2 public summary 7.5.2021 (pdf)
-
Septanazal (xylometazoline and dexpanthenol) RMP v.0.2 public summary 20.2.2019 (pdf)
-
Serdolect (sertindole) (pdf)
-
Seretide Diskus (salmeterol and fluticasone) (pdf)
-
Sertraline Accord (sertraline) RMP v.5.0 public summary 10.11.2015 (pdf) (pdf)
-
Sildenafil Orion (sildenafil) RMP v.2.0 public summary 30.9.2021 (pdf)
-
Sidenafil Pfizer / Viagra (pdf)
-
Sildenafil Teva Pharma (sildenafil) (pdf)
-
Sildorin (sildenafil) (pdf)
-
Sirturo (bedaquiline) (pdf)
-
Sitagliptin Krka (sitagliptin) RMP v.0.2 public summary 6.6.2019 (pdf)
-
Sitagliptin ratiopharm (sitagliptin) RMP v.2.0 public summary 22.6.2022 (pdf)
-
Sitagliptin STADA (sitagliptin) RMP v.1.1 public summary 23.7.2020 (pdf)
-
Sitagliptin/Metformin Krka (sitagliptin and metformin) RMP v.0.3 public summary 28.9.2020 (pdf)
-
Sitagliptin/Metformin Orion (sitagliptin and metformin) RMP v.1.0 public summary 12.12.2019 (pdf)
-
Sitagliptin/Metformin ratiopharm (sitagliptin and metformin) RMP v.1.0 public summary 22.10.2021 (pdf)
-
Sitagliptin/Metformin STADA (sitagliptin and metformin) RMP v.1.2 public summary 21.7.2021 (pdf)
-
Skudex (dexketoprofen and tramadol) (pdf)
-
Smofkabiven emulsion for infusion products (parenteral nutrition) RMP v.2.1 public summary 29.4.2021 (pdf)
-
Softacort (hydrocortisone) RMP v.2.1 public summary 20.5.2022 (pdf)
-
Solifenacin Accord (solifenacin) RMP v.4.0 public summary 22.9.2016 (pdf) (pdf)
-
Solifenacin Krka (solifenacin) RMP v.2.0 public summary 12.01.2022 (pdf)
-
Solifenacin Orion (solifenacin) RMP v.2.0 public summary 24.11.2021 (pdf)
-
Solifenacin Stada (solifenacin) (pdf)
-
Solifenacin/Tamsulosin STADA (solifenacin and tamsulosin) RMP v.2.0 public summary 2.12.2021 (pdf)
-
Sorafenib Stada (sorafenib) (pdf)
-
Spiriva (tiotropium) RMP v.11.0 public summary 17.5.2022 (pdf)
-
Spiriva Respimat (tiotropium) RMP v.11.0 public summary 17.5.2022 (pdf)
-
Spironolactone Orion (spironolactone) RMP v.1.0 public summary 22.3.2022 (pdf)
-
Srivasso (tiotropium) RMP v.11.0 public summary 17.5.2022 (pdf)
-
Stapressial (Atorvastatin, perindopril and amlodipine) (pdf)
-
Striverdi Respinat (olodaterol) RMP v.4.0 public summary 17.5.2022 (pdf)
-
Sugammadex Accord (sugammadex) RMP v.2.0 public summary 20.1.2023 (pdf)
-
Sugammadex Baxter (sugammadex) RMP v.0.1 public summary 3.6.2023 (pdf)
-
Sugammadex STADA (sugammadex) RMP v.1.2 public summary 27.7.2022 (pdf)
-
Sugammadex Orion (sugammadex) RMP v.1.0 public summary 4.10.2021 (pdf)
-
Sumatriptan Accord (sumatriptan) RMP v.4.0 public summary 7.1.2022 (pdf)
-
Sunitinib Krka (sunitinib) RMP v.1.0 public summary 21.11.2019 (pdf)
-
Sunosi (solriamfetol hydrochloride) (pdf)
-
Suxamethonium Ethypharm (suxamethonium chloride) (pdf)
-
Sylvant (siltuximab) (pdf)
-
Symbicort Turbuhaler (budesonide and formoterol) (pdf)
-
Synjardy (empagliflozin and metformin) (pdf)
T (Summaries of risk management plans)
-
Tacrolimus Accord [0.03% ointment] (tacrolimus) RMP v.0.1 public summary 1.6.2022 (pdf)
-
Tacrolimus Accord [0.1% ointment] (tacrolimus) RMP v.7.0 public summary 11.1.2021 (pdf)
-
Taflotan (tafluprost) (pdf)
-
Tafluprost Santen (tafluprost) (pdf)
-
Tadalafil Accord (tadalafil) RMP v.4.0 public summary 4.11.2023 (pdf)
-
Tadalafil Krka (tadalafil) RMP v.2.0 public summary 10.03.2021 (pdf)
-
Tadalafil Orion (tadalafil) RMP v.2.0 public summary 30.10.2023 (pdf)
-
Tadalafil ratiopharm (tadalafil) (pdf)
-
Tadalafil Stada Nordic (tadalafil) RMP v.1.0 public summary 5.12.2018 (pdf)
-
Tafluprost/Timolol Santen (tafluprost and timolol) RMP v.2.1 public summary 26.5.2023 (pdf)
-
Takhzyro (lanadelumab) (pdf)
-
Tamsurion (tamsulosin) RMP v.2.0 public summary 25.8.2022 (pdf)
-
Taptiqom (tafluprost and timolol) RMP v.2.0 public summary 18.12.2020 (pdf)
-
Targiniq (oxycodone and naloxone) (pdf)
-
Targocid (teicoplanin) (pdf)
-
Telfast (fexofenadine) (pdf)
-
Telmisartan/Hydrochlorothiazide Accord (telmisartan and hydrochlorothiazide) RMP v.3.0 public summary 17.12.2015 (pdf)
-
Telmisartan Orion (telmisartan) RMP v.2.1 public summary 14.1.2025 (pdf)
-
Tenofovir disoproxil Accord and tenofovir disoproxil Accordpharma (tenofovir disoproxil) RMP v.6.0 public summary 13.12.2022 (pdf)
-
Tenofovir disoproxil Orion (tenofovir disoproxil) (pdf)
-
Tenofovir disoproxil STADA (tenofovir disoproxil) (pdf)
-
Teriflunomide Krka (teriflunomide) RMP v.0.3 public summary 26.9.2022 (pdf)
-
Teriflunomide Orion (teriflunomide) RMP v.2.1 public summary 19.11.2024 (pdf)
-
Teriflunomide ratiopharm (teriflunomide) RMP v.3.1 public summary 27.9.2024 (pdf)
-
Teriflunomide STADA (teriflunomide) RMP v.0.5 public summary 8.9.2022 (pdf)
-
Testosterone ratiopharm (testosterone) RMP v.1.1 public summary 31.5.2022 (pdf)
-
Tetraspan and Venofundin (HES solution) (pdf)
-
Ticagrelor Accord (ticagrelor) RMP v.1.0 public summary 18.11.2024 (pdf)
-
Ticagrelor Krka (ticagrelor) RMP v.0.3 public summary 1.12.2020 (pdf)
-
Ticagrelor ratiopharm (ticagrelor) RMP v.1.2 public summary 21.6.2021 (pdf)
-
Ticagrelor STADA (ticagrelor) RMP v.1.3 public summary 19.5.2021 (pdf)
-
TicoVac and TicoVac Junior (TBE vaccination) (pdf)
-
Tigecycline Norameda (tigecycline) RMP v.0.2 public summary 31.5.2024 (pdf)
-
Tilamir (levetiracetam) RMP v.2.0 public summarry 13.12.2021 (pdf)
-
Tiotropium STADA (tiotropium) RMP v.0.2 public summary 24.5.2023 (pdf)
-
Tisseel and Artiss (fibrin glue) (pdf)
-
Toctino (alitretinoin) RMP v.11.1 public summary19.6.2019 (pdf)
-
Topimax (topiramate) RMP v.6.3 public summary 7.11.2024 (pdf)
-
Topiramat Orion (topiramate) RMP v.1.2 public summary 1.10.2024 (pdf)
-
Topiramat ratiopharm (topiramate) RMP v.1.3 public summary 19.12.2024 (pdf)
-
Topotecan Accord (topotecan) RMP v.0.2 public summary 3.4.2025 (pdf)
-
Trabectedin EVER Pharma (trabectedin) RMP v.0.3 public summary 13.9.2022 (pdf)
-
Trabectedin STADA (trabectedin) RMP v.1.0 public summary 5.5.2023 (pdf)
-
Tramadol Krka (tramadol) RMP v.3.0 public summary 17.2.2022 (pdf)
-
Tramadol/Paracetamol Accord (tramadol and paracetamol) RMP v.1.1 public summary 26.2.2021 (pdf)
-
Tramadol/Paracetamol Krka (tramadol and paracetamol) RMP v.1.1 public summary 3.5.2018 (pdf)
-
Tranexamic Acid Accord (tranexamic acid) RMP v.3.0 public summary 13.10.2016 (pdf)
-
Tranexamic acid Alternova (tranexamic acid) (pdf)
-
Tranexamic acid Baxter (tranexamic acid) RMP v.0.2 public summary 25.2.2020 (pdf)
-
Tranexamic acid Stragen (tranexamic acid) (pdf)
-
Tranexkabi (tranexamic acid) RMP v.0.1 public summary 15.9.2022 (pdf)
-
Travoprost/Timolol STADA (travoprost and timolol) (pdf)
-
Trexan (methotrexate) RMP v.3.2 public summary 29.6.2020 (pdf)
-
Triesence (triamcinolole) RMP v.3.0 public summary 21.10.2021 (pdf)
-
Triplixam (perindopril, indapamide and amlodipine) RMP v.2.0 public summary 24.4.2019 (pdf)
-
Triumeq (dolutegravir, abacavir and lamivudine) (pdf)
-
Triveram (atorvastatin, perindopril andamlodipine) (pdf)
-
Trulicity (dulaglutide) (pdf)
U (Summaries of risk management plans)
V (Summaries of risk management plans)
-
Vagiprev (etonogestrel and ethinylestradiol) (pdf)
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Valganciclovir Accord (valganciclovir) RMP v.2.0 public summary10.3.2014 (pdf)
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Valinger (sildenafil) RMP v.3.3 public summary 19.7.2021 (pdf)
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Valomindo (valsartan and indapamide) RMP v.1.2 public summary 16.9.2024 (pdf)
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Valproat Life Medical (sodium valproate) (pdf)
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Valsartan Hydrochlorothiazide Orion (valsartan and hydrochlorothiazide) (pdf)
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Valsartan Orion (valsartan) (pdf)
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Vancomycin Orion (vancomycin) (pdf)
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Vaprino (racecadotril) (pdf)
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Vardenafil Accord (vardenafil) RMP v.6.0 public summary 4.8.2022 (pdf)
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Vardenafil Krka (vardenafil) RMP v.5.5 public summary 5.5.2021 (pdf)
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Varenicline Orion (varenicline) RMP v.1.0 public summary 15.3.2024 (pdf)
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Varenicline ratiopharm (varenicline) RMP v.1.0 public summary 10.8.2023 (pdf)
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Varenicline STADA (varenicline) RMP v.1.0 public summary 10.6.2020 (pdf)
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Vargatef (nintedanib) (pdf)
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Varilrix (varicella zoster vaccine) RMP v.3.0 public summary 16.5.2023 (pdf)
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Varivax (varicella zoster vaccine) RMP v.2.0 public summary 20.7.2020 (pdf)
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Vaxigrip, VaxigripTetra (tri- and quadrivalent influenza vaccine) RMP v.8.0 public summary 23.10.2024 (pdf)
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Venlafaxin Orion (venlafaxine) RMP v.1 public summary 2.12.2020 (pdf)
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Venorion (venlafaxine) RMP v.2.0 public summary 27.4.2022 (pdf)
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Verorab (rabies virus, inactivated, whole virus) RMP v.2.1 public summary 3.3.2020 (pdf)
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Vigamox (moxifloxacin) RMP v.5.0 public summary 15.11.2022 (pdf)
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Vildagliptin Accord (vildagliptin) RMP v.2.0 public summary 11.12.2024 (pdf)
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Vildagliptin Krka (vildagliptin) RMP v.2.0 public summary 7.1.2023 (pdf)
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Vildagliptin STADA (vildagliptin) RMP v.1.2 public summary 27.1.2021 (pdf)
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Vildagliptin/Metformin Krka (vildagliptin and metformin) RMP v.1.0 public summary 7.1.2022 (pdf)
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Vildagliptin/Metformin STADA (vildagliptin and metformin) RMP v.1.1 public summary 10.6.2020 (pdf)
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Vinorelbine Accord [capsule] (vinorelbine) RMP RMP v.1.0 public summary 25.3.2021 (pdf)
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Vinorelbine Accord [concentrate for solution for infusion] (vinorelbine) RMP RMP v.4.0 public summary 23.1.2020 (pdf)
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Visanne (dienogest) RMP v.4.1 public summary 28.9.2020 (pdf)
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Volidax and Volidax Adult (lisdexamfetamine) RMP v.1.1 public summary 4.7.2022 (pdf)
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Voltaren (diclofenac sodium) (pdf)
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Volulyte 6% (hydroxyethyl starch and sodium chloride) (pdf)
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Voluven 6% (hydroxyethyl starch and sodium chloride) (pdf)
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Voluven 10% (hydroxyethyl starch and sodium chloride) (pdf)
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Voriconazole Accord and Voriconazol Accordpharma (voriconazole) RMP v.8.0 public summary 1.8.2024 (pdf)
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Voriconazole Fresenius Kabi (voriconazole) (pdf)
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Voriconazole Orion (voriconazole) (pdf)
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Voriconazole STADA (voriconazole) RMP v.1.1 public summary 20.7.2023 (pdf)
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Vortioxetine STADA (vortioxetine) RMP v.0.3 public summary 5.9.2023 (pdf)
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Voxra (bupropion) RMP v.10.0 public summary 14.9.2021 (pdf)
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Vreya (ethinylestradiol and cytoproterone) RMP v.2.4 public summary 30.8.2021 (pdf)
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Vyxeos Liposomal (cytarabine and daunorubicin hydrochloride) (pdf)
W (Summaries of risk management plans)
X (Summaries of risk management plans)
Z (Summaries of risk management plans)
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Zamisept (hexamidine diisetionate) RMP v.1.2 public summary 11.4.2022 (pdf)
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Zarelle (desogestrel) RMP v.1.2 public summary 8.3.2021 (pdf)
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Zavedos (idarubicin) RMP v.2.1 public summary 3.11.2022 (pdf)
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Zeldox (ziprasidone) RMP v.5.1 public summary 10.5.2017 (pdf)
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Zevtera (ceftobiprole) (pdf)
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Ziprasidon Pfizer (ziprasidone) RMP v.5.1 public summary 10.5.2017 (pdf)
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Zofran (ondansetron) RMP v.6.0 public summary 28.4.2022 (pdf)
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Zomacton (somatropin) (pdf)
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Zopiclone Orion (zopiclone) (pdf)
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Zyban (bupropion) RMP v.10.0 public summary 14.9.2021 (pdf)
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Zydelig (idelalisib) (pdf)
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Zysils (benzydamine) (pdf)