Summaries of risk management plans

Summaries of risk management plans

Instructions for the submission of Summaries of risk management plans (pdf)
 

Abacavir/Lamivudine Stada (abacavir and lamivudine) (pdf)

Abasaglar (insulin glargine) (pdf)

Abilify (aripiprazole) (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)

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)

Alendronat Bluefish (alendronic acid) (pdf)

Alfuzosin hydrochloride Orion (alfuzosin) (pdf)

Allegra (fexofenadine) (pdf)

Allopurinol Orion (allopurinol) RMP v.3.2 public summary 22.5.2018 (pdf)

Ambrisentan Accord (ambrisentan) (pdf)

Ambroxol ratiopharm (ambroxol) RMP v.1.1 public summary 11.2.2022 (pdf)

Amlodipin Orion (amlodipin) RMP v.2.0 public summary 17.2.2023 (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)

Ampres (chloroprocaine) (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.1.1 public summary 30.6.2023 (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)

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) (pdf)

Asmanex Twisthaler (mometasone) RMP v.4.0 public summary 25.8.2021 (pdf)

Astarior (atorvastatin and perindopril) (pdf)

Atomoxetin Orion (atomoxetine) (pdf)

Atorvastatin Pfizer (atorvastatin) (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)

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)

Belkyra (deoxycholic acid) (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)

Berocca Berries (multivitamin preparation) (pdf)

Betaklav (amoxicillin and clavulanic acid) RMP v.2.1 public summary 20.11.2020 (pdf)

Betaserc (betahistine) (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 Krka (bisoprolol) RMP v.1.2 public summary 18.9.2013 (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 Actavis (bosentan) (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) (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)

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/Hydrochlorithiazide Orion (candesartan and hydrochlorothiazide) RMP v.3.0 public summary 4.1.2023 (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)

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)

Celecoxib Krka (celecoxib) RMP v.1.2 public summary 13.9.2013 (pdf)

Celecoxib Pfizer (celecoxib) RMP v.4.0 public summary 5.10.2017 (pdf)

Ceranor (desogestrel) RMP v.1.1 public summary 22.10.2020 (pdf)

Cerdelga (eliglustat) (pdf)

Certican (everolimus) RMP v.5.0 public summary 26.11.2021 (pdf)

Cimzia (TNFα blocker) (pdf)

Ciprofloxacin Fresenius Kabi (ciprofloxacin) RMP v.0.2 public summary 18.10.2021 (pdf)

Ciprofloxacin Orion (ciprofloxacin) (pdf)

Ciqorin (ciclosporin) (pdf)

Cinacalcet ratiopharm (cinacalcet) RMP v.2.0 public summary 15.7.2020 (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 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)

Colrefuz (colchicine) RMP v.4.2 public summary 14.9.2022 (pdf)

Combigan (brimonidine and timolol) RMP v.2.0 public summary 10.10.2014 (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) (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)

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)

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 Medical Valley (darunavir) RMP v.1.0 public summary 4.12.2017 (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 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)

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)

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)

Duavive (conjugated oestrogens and bazedoxifene) (pdf)

Ducressa (dexamethasone and levofloxacin) (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)

Edipren (oxycodone and naloxone) (pdf)

Efedrin Abboxia (ephedrine) RMP v.1.0 public summary 31.10.2023 (pdf)

Efedrin Unimedic (ephedrine) (pdf)

Efexor Depot (venlafaxine) (pdf)

Eletriptan Orion (eletriptan) RMP v.2.0 public summary 20.6.2022 (pdf)

Elidel (pimecrolimus) (pdf)

Elvanse (lisdexamfetamine) RMP v.5.0 public summary 1.9.2021 (pdf)

Elymbus (bimatoprost) RMP v.1.2 public summary 8.3.2023 (pdf)

Emtenef (efavirenz, emtricitabine and tenofovir) (pdf)

Emtricitabine/Tenofovir disoproxil Accordpharma (emtricitabine and tenofovir disoproxil) RMP v.4.0 public summary 13.4.2023 (pdf)

Emtricitabine/Tenofovir disoproxil Krka (emtricitabine and tenofovir disoproxil) RMP v.5.1 public summary 9.6.2023 (pdf)

Emtricitabine/Tenofovir disoproxil Krka d.d. (emtricitabine and tenofovir disoproxil) RMP v.4.1. public summary 9.6.2023 (pdf)

Emtricitabine/Tenofovir disoproxil Stada (emtricitabine and tenofovir disoproxil) (pdf)

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)

EpiPen (epinephrine) (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)

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)

Exviera (dasabuvir) (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)

Ezetrol (ezetimibe) (pdf)

Faberka (tadalafil) (pdf)

Fampridine Stada (fampridine) RMP v.1.2 public summary 5.1.2022 (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 STADA (fesoterodine) RMP v.0.2 public summary 22.10.2020 (pdf)

Fexofenadine ratiopharm (fexophenadine) (pdf)

Fexorin (fexofenadine) (pdf)

Fibclot (fibrinogen) (pdf)

Fingolimod Krka (fingolimod) RMP v.1.1 public summary 2.9.2021 (pdf)

Fingolimod Medical Valley (fingolimod) RMP v.6.0 public summary 26.10.2021 (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)

Flexyess (Drospirenone and ethinylestradiol) (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)

FludeoMAP (fludeoxyglucose (18F)) RMP v.2.0 public summary 19.12.2022 (pdf)

Fluorescite (fluorescein sodium) (pdf)

Flusils hunaja-sitruuna (flurbiprofen) RMP v.2.2 public summary 13.7.2021 (pdf)

Fluticasone furoate ratiopharm (fluticasone furoate) RMP v.1.1 public summary 29.9.2023 (pdf)

Folic Acid Vitabalans (folic acid) (pdf)

Forminet (metformin) RMP v.1.2 public summary 27.1.2023 (pdf)

Fosastad (alendronate and colecalciferol) (pdf)

Fosfomycin Infectopharm (fosfomycin) (pdf)

Fosrenol (lanthanum) RMP v.10.0 public summary 11.7.2022 (pdf)

Fredomat (travoprost) (pdf)

Fulvestrant EVER Pharma (fulvestrant) RMP v.0.3 public summary 19.4.2018 (pdf)

Gabapentin Orion (gabapentin) RMP v.2.0 public summary 11.5.2022 (pdf)

Gabrion (gabapentin) (pdf)

Gasterix (lansoprazole) (pdf)

Gazyvaro (obinutuzumab) (pdf)

Gefitinib ratiopharm (gefinitib) (pdf)

Gemkabi (gemcitabine) (pdf)

Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide) (pdf)

Geloplasma (solution for infusion) (pdf)

Giotrif (afatinib) (pdf)

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)

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)

Ikervis (ciclosporin) (pdf)

Imatinib Fresenius Kabi (imatinib) (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)

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)

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)

Isotretinoin Actavis (isotretinoin) (pdf)

Itulazax (birch pollen extract)

Ivermectin Medical Valley (ivermectin) RMP v.1.0 public summary 28.4.2021 (pdf)

Ivermectin STADA (ivermectin) RMP v.1.0 public summary 20.10.2021 (pdf)

Ivermectine ratiopharm (ivermectine) RMP v.2.0 public summary 4.8.2023 (pdf)

Jardiance (empagliflozin) (pdf)

Jaydess (levonorgestrel) RMP v.9.1 public summary 1.9.2023 (pdf)

Jinarc (tolvaptan) (pdf)

Junyelt (parenteral nutrition) (pdf)

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)

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)

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 STADA (lenalidomide) RMP v.4.1 public summary 29.9.2020 (pdf)

Lercanidipin Orion (lerkadipine) (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) (pdf)

Linezolid Krka (linezolid) RMP v.1.1 public summary 29.6.2015 (pdf)

Lezolid Orionin (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)

Litalgin (metamizole sodium and pitofenone hydrochloride) RMP v.4.0 public summary 9.12.2022 (pdf)

Livial (tibolone) (pdf)

Lorazepam Macure (lorazepam) (pdf)

Lorazepam Orion (lorazepam) RMP v.1.0 public summary 14.6.2021 (pdf)

Losarion (losartan) RMP v.1.1 public summary 21.4.2017 (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)

Lutinus (progesterone) (pdf)

Lynparza (olaparib) (pdf)

Makrogoli Orion (macrogol 4000) (pdf)

Medipekt (bromhexine) (pdf)

Meditus (acetylcysteine) RMP v.2.0 public summary 27.1.2022 (pdf)

Melatonin Orion (melatonin) (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 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 (methotrexate) (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.2.2 public summary 10.11.2023 (pdf)

Milnocor (milrinone) (pdf)

Minirin (desmopressin) (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)

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) (pdf)

Naloxone Accord (naloxone) RMP v.1.3 public summary 31.10.2022 (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)

Neofordex (dexamethasone) (pdf)

Neotigason (acitretin) (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)

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)

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)

Norspan (buprenorphine) (pdf)

Novantrone (mitoxantrone) (pdf)

Noviana (oestrogen) (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)

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 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)

Olysio (simeprevir) (pdf)

Omeprazol Orion (Omeprazole) (pdf)

Ondansetron Fresenius Kabi (ondansetron) RMP v.0.2 public summary 7.1.2022 (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)

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 ratiopharm (oxycodone) (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)

OxyContin, OxyNorm (oxycodone) (pdf)

Oxycorion Depot (oxycodone) RMP v.3.0 public summary 5.1.2023 (pdf)

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)

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)

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 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)

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.1.1 public sumary 23.12.2021 (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)

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)

Prednisolon Alternova (prednisolon) (pdf)

Pregabalin Krka (pregabalin) RMP v.3.0 public summary 1.6.2022 (pdf)

Pregabalin Orion, Pregabalin Orion Pharma (pregabalin) RMP v.5.0 public summary 16.8.2023 (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.7.0 public summary 9.1.2019 (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)

Prothromplex (prothrombin complex coagulation factors) (pdf)

Prucalopride Stada (prucalopride) (pdf)

Pyrvin (pyrvinium) RMP v.1.0 public summary 17.9.2021 (pdf)

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 Teva (quetiapine) RMP v.4.1 public summary 16.9.2022 (pdf)

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 Orion (rasagiline) (pdf)

Regiocit (solution for haemofiltration) (pdf)

Remeron SolTab (mirtazapine) (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 Xiromed (rosuvastatin) RMP v.4.0 public summary 10.12.2019 (pdf)

Rosuvastatin/Ezetimibe ratiopharm (rosuvastatin and ezemibe) (pdf)

Rosuvastatin Stada (rosuvastatin) (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)

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.0.2 public summary 7.3.2019 (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 (salmeterol and fluticasone) (pdf)

Sildenafil Orion (sildenafil) RMP v.2.0 public summary 30.9.2021 (pdf)

Sidenafil Pfizer / Viagra (sildenafil) (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 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)

Strattera (atomoxetine) (pdf)

Striverdi Respinat (olodaterol) RMP v.4.0 public summary 17.5.2022 (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)

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)

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 HCTZ ratiopharm (Telmisartan and hydrochlorothiazide) (pdf)

Telmisartan Orion (telmisartan) (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 ratiopharm (teriflunomide) RMP v.1.4 public summary 13.7.2023 (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 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)

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.5.0 public summary 22.5.2018 (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 Alternova (tranexamic acid) (pdf)

Tranexamic acid Baxter (tranexamic acid) RMP v.0.2 public summary 25.2.2020 (pdf)

Tranexamic acid Orion (tranexamic acid) (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)

Valganciclovir Accord (valganciclovir) RMP v.2.0 public summary10.3.2014 (pdf)

Valganciklovir Teva (valganciclovir) (pdf)

Valinger (sildenafil) RMP v.3.3 public summary 19.7.2021 (pdf)

Valproat Life Medical (sodium valproate) (pdf)

Valsartan Hydrochlorothiazide Orion (valsartan and hydrochlorothiazide) (pdf)

Valsartan Orion (valsartan) (pdf)

Vancomycin Orion (vancomycin) (pdf)

Vaprino (racecadotril) (pdf)

Vardenafil Accord (vardenafil) RMP v.6.0 public summary 4.8.2022 (pdf)

Vardenafil Krka (vardenafil) RMP v.5.5 public summary 5.5.2021 (pdf)

Varenicline ratiopharm (varenicline) RMP v.1.0 public summary 10.8.2023 (pdf)

Vargatef (nintedanib) (pdf)

Varilrix (varicella zoster vaccine) RMP v.3.0 public summary 16.5.2023 (pdf)

Varivax (varicella zoster vaccine) RMP v.2.0 public summary 20.7.2020 (pdf)

VaxigripTetra (quadrivalent influenza vaccine) RMP v.7.0 public summary 12.9.2019 (pdf)

Vectatone (penciclovir) (pdf)

Venlafaxin Orion (venlafaxine) RMP v.1 public summary 2.12.2020 (pdf)

Venorion (venlafaxine) RMP v.2.0 public summary 27.4.2022 (pdf)

Verorab (rabies virus, inactivated, whole virus) RMP v.2.1 public summary 3.3.2020 (pdf)

Viacoram (perindopril and amlodipine) RMP v.3.0 public summary 2.11.2021 (pdf)

Viekirax (ombitasvir, paritaprevir and ritonavir) (pdf)

Vigamox (moxifloxacin) RMP v.5.0 public summary 15.11.2022 (pdf)

Vildagliptin Accord (vildagliptin) RMP v.2.0 public summary 11.12.2024 (pdf)

Vildagliptin Krka (vildagliptin) RMP v.2.0 public summary 7.1.2023 (pdf)

Vildagliptin STADA (vildagliptin) RMP v.1.2 public summary 27.1.2021 (pdf)

Vildagliptin/Metformin Krka (vildagliptin and metformin) RMP v.1.0 public summary 7.1.2022 (pdf)

Vildagliptin/Metformin STADA (vildagliptin and metformin) RMP v.1.1 public summary 10.6.2020 (pdf)

Vinorelbine Accord [capsule] (vinorelbine) RMP RMP v.1.0 public summary 25.3.2021 (pdf)

Vinorelbine Accord [concentrate for solution for infusion] (vinorelbine) RMP RMP v.4.0 public summary 23.1.2020 (pdf)

Visanne (dienogest) RMP v.4.1 public summary 28.9.2020 (pdf)

Volidax and Volidax Adult (lisdexamfetamine) RMP v.1.1 public summary 4.7.2022 (pdf)

Voltaren (diclofenac sodium) (pdf)

Volulyte 6% (hydroxyethyl starch and sodium chloride) (pdf)

Voluven 6% (hydroxyethyl starch and sodium chloride) (pdf)

Voluven 10% (hydroxyethyl starch and sodium chloride) (pdf)

Voriconazol Accordpharma (voriconazole) RMP v.7.2 public summary 26.1.2024 (pdf)

Voriconazole Fresenius Kabi (voriconazole) (pdf)

Voriconazole Orion (voriconazole) (pdf)

Voriconazole STADA (voriconazole) RMP v.1.1 public summary 20.7.2023 (pdf)

Vortioxetine STADA (vortioxetine) RMP v.0.3 public summary 5.9.2023 (pdf)

Voxra (bupropion) RMP v.10.0 public summary 14.9.2021 (pdf)

Vreya (ethinylestradiol and cytoproterone) RMP v.2.4 public summary 30.8.2021 (pdf)

Vyxeos Liposomal (cytarabine and daunorubicin hydrochloride) (pdf)

Water for Injections CSL Behring RMP v.1.0 public summary 24.10.2018 (pdf)

Xalatan (latanoprost) RMP v.5.0 public summary 2.2.2017 (pdf)

Xultophy (insulin degludec and liraglutide) (pdf)

Yanimo Respimat (tiotropium and olodaterol) RMP v.5.0 public summary 18.5.2022 (pdf)

Yasmin (drospirenone and ethinylestradiol) (pdf)

Yasminelle (drospirenone and ethinylestradiol) (pdf)

Yaz (drospirenone and ethinylestradiol) (pdf)

Zamisept (hexamidine diisetionate) RMP v.1.2 public summary 11.4.2022 (pdf)

Zarelle (desogestrel) RMP v.1.2 public summary 8.3.2021 (pdf)

Zavedos (idarubicin) RMP v.2.1 public summary 3.11.2022 (pdf)

Zeldox (ziprasidone) RMP v.5.1 public summary 10.5.2017 (pdf)

Zevtera (ceftobiprole) (pdf)

Ziprasidon Pfizer (ziprasidone) RMP v.5.1 public summary 10.5.2017 (pdf)

Zofran (ondansetron) RMP v.6.0 public summary 28.4.2022 (pdf)

Zoledronic Acid Agila (zoledronic acid) (pdf)

Zomacton (somatropin) (pdf)

Zontivity (vorapaxar) (pdf)

Zopiclone Orion (zopiclone) (pdf)

Zyban (bupropion) RMP v.10.0 public summary 14.9.2021 (pdf)

Zydelig (idelalisib) (pdf)

Zysils (benzydamine) (pdf)