LUONNOS Summaries of risk management plans
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Abacavir Accord (abacavir) RMP v.7.0 public summary 10.3.2021 (pdf) - Abacavir/Lamivudine (abacavir and lamivudine) RMP v.4.0 public summary 16.2.2021 (pdf)
- Abacavir/Lamivudine Stada (abacavir and lamivudine) (pdf)
- Abasaglar (insulin glargine) (pdf)
- Abirateron Medical Valley (abiraterone) RMP v.3.0 public summary 29.1.2024 (pdf)
- Abiraterone Orion (abiraterone) RMP v.1.1 public summary 18.8.2020 (pdf)
- Abiraterone ratiopharm (abiraterone) RMP v.1.2 public summary 10.3.2022 (pdf)
- Abiraterone STADA (abiraterone) RMP v.0.2 public summary 1.3.2021 (pdf)
- Absenor (sodium valproate) (pdf)
- Abstral (fentanyl) (pdf)
- Acarizax (dermatophagoides farinae, dermatophagoides pteronyssinus) (pdf)
- Aciclovir Accord (aciclovir) RMP v1.1 public summary 17.7.2019 (pdf)
- Actilyse (alteplase) RMP v.11.0 public summary 18.8.2023 (pdf)
- Addaven (concentrate for Solution for Infusion) RMP v.8.1 public summary 22.2.2021 (pdf)
- Adempas (riociguat) (pdf)
- Adynovi (rurioctocog alfa pegol) (pdf)
- Agomelatine Anpharm (agomelatine) RMP v.24.0 public summary 22.10.2020 (pdf)
- Agomelatine ratiopharm (agomelatine) (pdf)
- Albuman (human albumin) (pdf)
- Albumin Baxalta (albumin) RMP v.3.1 public summary 24.1.2020 (pdf)
- Alburex (human albumin) (pdf)
- Alendronat ratiopharm (alendronic acid) (pdf)
- Alfuzosin hydrochloride Orion (alfuzosin) (pdf)
- Allopurinol Accord (allopurinol) RMP v.1.1 public summary 25.1.2019 (pdf)
- Allopurinol Orion (allopurinol) RMP v.3.2 public summary 22.5.2018 (pdf)
- Ambrisentan Accord (ambrisentan) (pdf)
- Amlodipin Accord (amlodipine) RMP v.3.0 public summary 23.1.2020 (pdf)
- Amlodipine/Valsartan/Hydrochlorothiazide Krka (amlodipine, valsartan and hydrochlorothiazide) RMP v.0.2 public summary 26.7.2018 (pdf)
- Amlodipin/Valsartan Krka (amlodipine and valsartan) RMP v.2.2 public summary 16.7.2020 (pdf)
- Amorion Comp (amoxicillin and clavulanic acid) RMP v.2.0 public summary 30.7.2021 (pdf)
- Ampicillin STADA Nordic (ampicillin) RMP v.0.2 public summary 15.2.2024 (pdf)
- Ampres (chloroprocaine) (pdf)
- Anidulafungin Accord (anidulafungin) RMP v.3.0 public summary 2.12.2022 (pdf)
- Anksilon (buspirone) RMP v.1.0 public summary 17.5.2021 (pdf)
- Apixaban Krka (apixaban) RMP v.0.3 public summary 16.9.2021 (pdf)
- Apixaban Orion (apixaban) RMP v.2.1 public summary 12.12.2024 (pdf)
- Apixaban ratiopharm GmbH (apixaban) RMP v.3.0 public summary 28.9.2022 (pdf)
- Apixaban Stada (apixaban) RMP v.1.1 public summary 5.2.2021 (pdf)
- Apremilast Krka (apremilast) RMP v.0.2 public summary 29.4.2024 (pdf)
- Apremilast ratiopharm (apremilast) RMP v.1.1 public summary 6.12.2023 (pdf)
- Apremilast STADA (apremilast) RMP v.1.2 public summary 11.9.2024 (pdf)
- Aprokam (cefuroxime) RMP v.3.1 public summary 7.11.2022 (pdf)
- Arcoxia (etoricoxib) (pdf)
- Aripiprazol Krka (aripiprazole) RMP v.3.0 public summary 28.12.2017 (pdf)
- Aripiprazol Stada (aripiprazole) (pdf)
- Aripiprazol Stada (aripiprazole oral solution) (pdf)
- Aripiprazole Orion (aripiprazole) (pdf)
- Aripiprazole ratiopharm (aripiprazole) RMP v.5.1 public summary 16.12.2024 (pdf)
- Asmanex Twisthaler (mometasone) RMP v.4.0 public summary 25.8.2021 (pdf)
- Astarior (atorvastatin and perindopril) (pdf)
- Atomoxetine Accord (atomoxetine) RMP v.1.1 public summary 12.10-2028 (pdf)
- Atomoxetin Orion (atomoxetine) (pdf)
- Atorvastatin Accord (atorvastatin) RMP v.2.0 public summary 4.7.2016 (pdf) (pdf)
- Atorvastatin Pfizer (atorvastatin) (pdf)
- Atorvastatin Teva (atorvastatin) RMP v.1.2 public summary 30.10.2023 (pdf)
- Atosiban Accord (atosiban) RMP v.3.0 public summary 18.4.2024 (pdf)
- Atosiban Ever Pharma (atosiban) (pdf)
- Atropin Abboxia (atropine) RMP v.2.0 public summary 26.2.2024 (pdf)
- Atropine Accord (atropine) RMP v.1.1 public summary 23.12.2019 (pdf)
- Attadex (dexamphetamine) RMP v.1.1 public summary 10.8.2023 (pdf)
- Avelox (moxifloxacin (pdf)
- Avodart (dutasteride) RMP v.8.2 public summary 26.10.2017 (pdf)
- Axitinib STADA (axitinib) RMP v.1.0 public summary 21.7.2021 (pdf)
- Azeflone (azelastine hydrochloride and fluticasone propionate) RMP v.0.2 public summary 2.3.2023 (pdf)
- Azacitidine Stada (azacitidine) (pdf)
- Azithromycin Krka (azithromycin) RMP v.1.2 public summary 6.12.2013 (pdf)
- Azotorion (azithromycin) (pdf)
- Azyter (azithromycin) (pdf)
- Bartal (acetylsalicylic acid) RMP v.2.0 public summary 3.3.2021 (pdf)
- Bendamustine Accord (bendamustine) RMP v.10.0 public summary 1.10.2021 (pdf)
- Bendamustine Fresenius Kabi (bendamustine) (pdf)
- Benelyte (solution for infusion) RMP v.3.1 public summary 24.1.2020 (pdf)
- Benzylpenicillin Fresenius Kabi (benzylpenicillin sodium) RMP v.0.1 public summary 17.8.2022 (pdf)
- Berinert (human C1 esterase inhibitor) (pdf)
- Betaklav (amoxicillin and clavulanic acid) RMP v.2.1 public summary 20.11.2020 (pdf)
- Betaserc (betahistine) (pdf)
- Bicalutamide Accord (bicalutamide) RMP v.1.0 public summary 24.7.2018 (pdf)
- Bimatix (imatinib) RMP v.0.3 public summary 20.9.2024 (pdf)
- Bimatoprost Stada (bimatoprost) (pdf)
- Bimatoprost/Timolol Stada (bimatoprost and timolol) (solution in single-dose container) RMP v.0.3 public summary 24.2.2021 (pdf)
- Biphozyl (solution for haemodialysis/haemofiltration) (pdf)
- Biquetan (quetiapine) (pdf)
- Bisolaclar (acetylcysteine) (pdf)
- Bisoprolol Accord (bisoprolol) RMP v.3.0 public summary 16.1.2020 (pdf)
- Bisoprolol Krka (bisoprolol) RMP v.1.2 public summary 18.9.2013 (pdf)
- Bleomycin Accord (bleomycin) RMP v.3.0 public summary 24.3.2022 (pdf)
- Boostrix (booster vaccination against diphtheria, tetanus and pertussis) RMP v.7.0 public summary 14.2.2020 (pdf)
- Boostrix Polio (booster vaccination against diphtheria, tetanus, poliomyelitis and pertussis) RMP v.7.0 public summary 14.2.2020 (pdf)
- Bortezomib Baxter (bortezomib) RMP v.0.2 public summary 24.8.2021 (pdf)
- Bortezomib EVER Pharma (bortezomib) RMP v.0.3 public summary 15.7.2021 (pdf)
- Bortezomib Krka (bortezomib) RMP v.1.0 public summary 14.4.2020 (pdf)
- Bortezomib Medical Valley (bortezomib) RMP v.2.0 public summary 5.5.2020 (pdf)
- Bortezomib Vivanta (bortetsomib) (pdf)
- Bosentan Accord (bosentan) RMP v.6.0 public summary 3.12.2019 (pdf)
- Bosentan Orion (bosentan) RMP v.1.0 public summary 30.7.2019 (pdf)
- Bosutinib STADA (bosutinib) RMP v.1.1 public summary 17.8.2023 (pdf)
- Botox and Vistabel (botulinum toxin type A) RMP v.9.6 public summary 1.2.2023 (pdf)
- Brevibloc (esmolol) RMP v.8.2 public summary 16.12.2024 (pdf)
- Brinzolamide Accord (brinzolamide) RMP v.6.0 public summary 13.5.2022 (pdf)
- Brivaracetam ratiopharm (brivaracetam) RMP v.1.2 publiv summary 9.1.2025 (pdf)
- Brivaracetam STADA (brivaracetam) RMP v.0.4 public summary 6.2.2025 (pdf)
- Briviact (brivaracetam) (pdf)
- Brinzolamide/Brimonidine STADA (brinzolamide and brimonidine) RMP v.1.0 public summary 14.7.2022 (pdf)
- Budesonid Medical Valley (budesonide) RMP v.2.0 public summary 18.1.2023 (pdf)
- Budesonide Teva (budesonide) (pdf)
- Bugvi (paclitaxel) RMP v.1.1 public summary 14.11.2023 (pdf)
- Bupivacaine Accord (bupivacaine) RMP v.3.0 public summary 3.11.2015 (pdf)
- Bupivacaine Spinal Tung Aguettant (bupivacaine) RMP v.0.5 public summary 27.11.2024 (pdf)
- Buprenorphine ratiopharm (buprenorphine) (pdf)
- Buprenorphine Stada (buprenorphine) (pdf)
- Bupropion Accord (bupropion) RMP v.7.0 public summary 24.1.2024 (pdf)
- Bupropion Orion (bupropion) RMP v.2.1 public summary 4.4.2022 (pdf)
- Burana powder for oral solution in sachet (ibuprofen) (pdf)
- Burana oral suspension (ibuprofen) (pdf)
- Buscopan (hyoscine butylbromide) (pdf)
- Buvidal (buprenorphine) (pdf)
- Cabazitaxel EVER Pharma (cabazitaxel) RMP v.0.2 public summary 29.10.2019 (pdf)
- Cabazitaxel Fresenius Kabi (cabazitaxel) RMP v.0.3 public summary 31.5.2022 (pdf)
- Cabazitaxel Medical Valley (cabazitaxel) RMP v.3.0 public summary 27.10.2021 (pdf)
- Calcichew (calcium carbonate and cholecalciferol) (pdf)
- Calciumfolinat Fresenius Kabi (calcium folinate) (pdf)
- Calciumgluconat B.Braun (calcium gluconate) (pdf)
- Canagliflozin ratiopharm (canagliflozin) RMP v.1.0 public summary 9.4.2024 (pdf)
- Candecam (candesartan and amlodipine) RMP v.2.0 public summary 17.9.2018 (pdf)
- Candesartan STADA (candesartan) RMP v.4.0 public summary 27.11.2024 (pdf)
- Candesartan/Hydrochlorithiazide Orion (candesartan and hydrochlorothiazide) RMP v.3.0 public summary 4.1.2023 (pdf)
- Candesartan/Indapamide Krka (candesartan and indapamide) RMP v.0.1 public summary 25.7.2023 (pdf)
- Canesderm (clotrimazole) RMP v.3.1 public summary 22.5.2020 (pdf)
- Canespor (bifonazole) (pdf)
- Capecitabine Orion (capecitabine) RMP v.3.0 public summary 9.6.2020 (pdf)
- Carboplatin Accord (carboplatin) RMP v1.1 public summary 6.7.2018 (pdf)
- Carmustine Accord (carmustine) RMP v.1.2 public summary 18.6.2021 (pdf)
- Carmustine Accordpharma (carmustine) RMP v.1.0 public summary 24.11.2020 (pdf)
- Carmustine Macure (carmustine) (pdf)
- Cartexan (chondroitin sulfate) (pdf)
- Casodex (bicalutamide) (pdf)
- Caspofungin Orion (caspofungin) RMP v.3.0 public summary 20.10.2022 (pdf)
- Caspofungin Stada (caspofungin) RMP v.1.1 public summary 10.12.2020 (pdf)
- Celebra (celecoxib) RMP v.4.0 public summary 5.10.2017 (pdf)
- Certican (everolimus) RMP v.5.0 public summary 26.11.2021 (pdf)
- Cimzia (TNFα blocker) (pdf)
- Cinacalcet Accord (cinacalcet) RMP v.2.0 public summary 12.12.2023 (pdf)
- Cinacalcet Orion (cinacalcet) RMP v.3.0 public summary 19.7.2024 (pdf)
- Cinacalcet ratiopharm (cinacalcet) RMP v.2.0 public summary 15.7.2020 (pdf)
- Ciprofloxacin Fresenius Kabi (ciprofloxacin) RMP v.0.2 public summary 18.10.2021 (pdf)
- Ciprofloxacin Orion (ciprofloxacin) (pdf)
- Ciqorin (ciclosporin) (pdf)
- Cisatracurium Accord (cisatracurium) RMP v.2.0 public summary 26.3.2024 (pdf)
- Cisatracurium Accordpharma (cisatracurium) RMP v.1.1 public summary 17.5.2021 (pdf)
- Cisplatin Accord (cisplatin) RMP v.4.0 public summary 25.11.2015 (pdf)
- Clarithromycin Krka (clarithromycin) RMP v.1.1 public summary 27.5.2016 (pdf)
- Clindoxyl (Clindamycin and benzoyl peroxide) RMP v.3.0 public summary 7.1.2020 (pdf)
- Clinimix (solution for infusion for parenteral nutrition) RMP v.3.3 public summary 10.5.2023 (pdf)
- Clopidogrel Orion (clopidogrel) RMP v.2.0 public summary 30.3.2021 (pdf)
- Clopidrion (clopidogrel) (pdf)
- Cloxacillin Stragen (cloxacillin) RMP v.1.2 public summary 28.6.2021 (pdf)
- Clozapine Accord (clozapine) RMP v.7.0 public summary 20.4.2023 (pdf)
- Clozapine STADA (clozapine) RMP v.1.2 public summary 15.3.2024 (pdf)
- Cluvot (human factor XIII concentrate) (pdf)
- Cofact (clotting factors II, VII, IX and X) (pdf)
- Cohemin (hydroxocobalamin acetate) RMP v.1.1 public summary 6.3.2024 (pdf)
- Colrefuz (colchicine) RMP v.4.2 public summary 14.9.2022 (pdf)
- Combigan (brimonidine and timolol) RMP v.3.2 public summary 26.9.2024 (pdf)
- Concerta (methylphenidate) RMP v.10.2 public summary 28.7.2023 (pdf)
- Confidex (human prothrombinex complex concentrate) RMP v.3.0 public summary 29.10.2020 (pdf)
- Copaxone (glatiramer acetate) RMP v.8.0 public summary 6.12.2024 (pdf)
- Cortiment (budesonide) RMP v.3.0 public summary 20.12.2019 (pdf)
- Cosopt (dorzolamide and timolol) (pdf)
- Cosyrel (Bisoprolol and perindopril) RMP v.1.1 public summary 7.5.2020 (pdf)
- Cotellic (cobimetinib) (pdf)
- Coveram (perindopril and amlodipine) RMP v.3.0 public summary 2.11.2021 (pdf)
- Coversyl Comp Novum (perindopril and indapamide) RMP v.3.0 public summary 24.6.2022 (pdf)
- Cozaar (losartan) (pdf)
- Creon (pancreatin) (pdf)
- Crestor (rosuvastatin) RMP v.5.0 public summary 15.2.2019 (pdf)
- Cuvitru (human normal immunoglobulin) RMP v.2.0 public summary 24.11.2020 (pdf)
- Cyclophosphamide Accord (cyclophosphamide) RMP v.1.1 public summary 24.9.2020 (pdf)
- Cypretyl (cyproteroneacetate and ethinylestradiol) (pdf)
- Cyramza (ramucirumab) (pdf)
- Cytarabine Accord (cytarabine 100mg/ml solution for injection/infusion) RMP v.2.0 public summary 23.10.2013 (pdf)
- Cytarabine Accord Healthcare (cytarabine 20mg/ml solution for injection/infusion) RMP v.1.0 public summary 19.1.2017 (pdf)
- Dabigatran etexilate Krka (dabigatran etexilate) RMP v.0.5 public summary 4.10.2023 (pdf)
- Dabigatran etexilate Stada (dabigatran etexilate) RMP v.1.3 public summary 19.9.2023 (pdf)
- Dabigatran etexilate STADA Nordic (dabigatran etexilate) RMP v.1.3 public summary 19.9.2023 (pdf)
- Dacepton (apomorphine) (pdf)
- Dagraduo (sitagliptin and dapagliflozin) RMP v.0.4 public summary 14.2.2025 (pdf)
- Daivobet (calcipotriol and betamethasone dipropionate) (pdf)
- Dalacin (clindamycin) (pdf)
- Dapagliflozin Krka (dapagliflozin) RMP v.0.4 public summary 24.7.2023 (pdf)
- Daptomycin Accord Healthcare (daptomycin) RMP v.6.0 public summary 25.10.2021 (pdf)
- Daptomycin Accordpharma (daptomycin) RMP v.6.0 public summary 25.10.2021 (pdf)
- Darunavir Accord (darunavir) RMP v.1.0 public summary 25.6.2018 (pdf)
- Darunavir Medical Valley (darunavir) RMP v.1.3 public summary 20.8.2024 (pdf)
- Darunavir Stada (darunavir) (pdf)
- Dasatinib Krka (dasatinib) RMP v.3.0 public summary 15.4.2019 (pdf)
- Deferasirox Stada (deferasirox) (pdf)
- Defitelio (defibrotide) (pdf)
- Deprakine (valproate) RMP v.6.2 public summary 23.7.2021 (pdf)
- Desflurane Baxter (desflurane) RMP v.2.2 public summary 21.7.2023 (pdf)
- Desloratadin Orion (desloratadine) RMP v.2.1 public summary 25.10.2021 (pdf)
- Desloratadine Actavis (desloratadine) (pdf)
- Desmopressin Orion (desmopressin) RMP v.1.2 public summary 15.5.2024 (pdf)
- Desmopressin ratiopharm (desmopressin) RMP v.0.2 public summary 14.3.2022 (pdf)
- Desmopressin STADA (desmopressin) RMP v.0.2 public summary 14.3.2022 (pdf)
- Destamin (desloratadine) (pdf)
- Detremin (cholecalciferol) (pdf)
- Dexacur (dexamethasone) RMP v.2.0 public summary 2.6.2021 (pdf)
- Dexamethasone phosphate Kabi (dexamethasone) RMP v.3.1 public summary 27.10.2020 (pdf)
- Dexdor (dexmedetomidine) (pdf)
- Dexketoprofen Krka (dexketoprofen) RMP v.0.2 public summary 10.9.2018 (pdf)
- Dexmedetomidine B. Braun (dexmedetomidine) (pdf)
- Dexmedetomidine Baxter (dexmedetomidine) RMP v.0.2 public summary 5.11.2020 (pdf)
- Dexmedetomidine Kabi (dexmedetomidine) RMP v.0.1 public summary 18.2.2021 (pdf)
- Diane Nova (cyproterone acetate and ethinylestradiol) (pdf)
- Diazepam Accord (diazepam) (pdf)
- Dicloabak (diclofenac sodium) (pdf)
- Diclofenac STADA (diclofenac) RMP v.1.1 public summary 19.4.2023 (pdf)
- Digoxin Orion (digoxin) (pdf)
- Dienogest Stragen (dienogest) RMP v.1.0 public summary 17.1.2019 (pdf)
- Dimethyl fumarate STADA (dimethyl fumarate) RMP v.1.1 public summary 10.8.2022 (pdf)
- Dimethyl fumarate STADA Nordic (dimethyl fumarate) RMP v.0.3 public summary 19.12.2024 (pdf)
- Dimethyl fumarate Teva GmbH (dimethyl fumarate) RMP v.1.2 public summary 11.10.2024 (pdf)
- Diovan (valsartan) (pdf)
- Ditustin (levodropropizine) RMP v.2.0 public summary 12.5.2023 (pdf)
- Divisun (colecalciferol) (pdf)
- Doneprion (donepezil) (pdf)
- Dopital (mexiletine) RMP v.0.1 public summary 7.6.2021 (pdf)
- Doxorubicin Accord (doxorubicin) RMP v1.0 public summary 23.8.2029 (pdf)
- Droperidol Aguettant (droperidol) RMP v.0.2 public summary 24.1.2024 (pdf)
- Duavive (conjugated oestrogens and bazedoxifene) (pdf)
- Ducressa (dexamethasone and levofloxacin) (pdf)
- Duloxetine Accord (duloxetine) RMP v.6.0 public summary 10.2.2022 (pdf)
- Duloxetine Accordpharma (duloxetine) RMP v.1.1 public summary 25.6.2019 (pdf)
- Duloxetine Krka (duloxetine) RMP v.4.0 public summary 10.11.2020 (pdf)
- Duloxetine Orion (duloxetine) RMP v.2.0 public summary 19.11.2020 (pdf)
- Duloxetine ratiopharm (duloxetine) (pdf)
- Duloxetin Stada (duloxetine) (pdf)
- Duodart (dutasteride and tamsulosin) RMP v.8.2 public summary 26.10.2017 (pdf)
- Duodopa (levodopa and carbidopa) RMP v.11.0 public summary 1.11.2023 (pdf)
- Duokopt (dorzolamide and timolol) (pdf)
- Duonasa (azelastine+fluticasone propionate) RMP v.1.0 public summary 2.9.2021 (pdf)
- Duosol (solution for haemofiltration) (pdf)
- Duphalac fruit (lactulose) (pdf)
- Dutasteride Krka (dutasteride) RMP v.2.0 public summary 14.12.2020 (pdf)
- Dutasteride Medical Valley (dutasteride) RMP v.0.2 public summary 10.5.2019 (pdf)
- Dutasteride ratiopharm (dutasteride) (pdf)
- Dutasteride/Tamsulosin Orion (dutasteride and tamsulosin) (pdf)
- Dutasteride/Tamsulosin ratiopharm (dutasteride and tamsulosin) (pdf)