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.10.0 public summary 21.1.2020 (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)
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 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)
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 Ever Pharma (atosiban) (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)
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)
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)
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)
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)
Botox and Vistabel (botulinum toxin type A) RMP v.9.5 public summary 14.7.2022 (pdf)
Brevibloc (esmolol) (pdf)
Briviact (brivaracetam) (pdf)
Budesonid Medical Valley (budesonide) RMP v.2.0 public summary 18.1.2023 (pdf)
Budesonide Teva (budesonide) (pdf)
Buprenorphine ratiopharm (buprenorphine) (pdf)
Buprenorphine Stada (buprenorphine) (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)
Candecam (candesartan and amlodipine) RMP v.2.0 public summary 17.9.2018 (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)
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)
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.9.1 public summary 2.6.2022 (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)
Cypretyl (cyproteroneacetate and ethinylestradiol) (pdf)
Cyramza (ramucirumab) (pdf)
Dacepton (apomorphine) (pdf)
Daivobet (calcipotriol and betamethasone dipropionate) (pdf)
Dalacin (clindamycin) (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)
Desloratadin Orion (desloratadine) RMP v.2.1 public summary 25.10.2021 (pdf)
Desloratadine Actavis (desloratadine) (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 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)
Ditustat (levodropropizine) RMP v.1.0 public summary 30.11.2022 (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.9.0 public summary 1.11.2020 (pdf)
Duokopt (dorzolamide and timolol) (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.0.1 public summary 21.1.2019 (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 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)
Emtenef (efavirenz, emtricitabine and tenofovir) (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.7.0 public summary 30.3.2021 (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.4.0 public summary 28.9.2018 (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)
Fixopost (latanoprost and timolol) (pdf)
Flecainide Orion (flecainide) RMP v.3.0 public summary 10.2.2022 (pdf)
Flexyess (Drospirenone and ethinylestradiol) (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)
Folic Acid Vitabalans (folic acid) (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)
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-C (ibuprofen) (pdf)
Ibuprofen B.Braun (ibuprofen) (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)
Immunate (factor VIII and human von Willebrand factor)
Imodium (loperamide) (pdf)
Imodium Plus (loperamide and simethicone) (pdf)
Incruse (umeclidinium bromide) (pdf)
Influvac (influenza vaccine) (pdf)
Innohep (tinzaparin sodium) (pdf)
Inspiolto Respimat (tiotropium and olodaterol) (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)
Isotretinoin Actavis (isotretinoin) (pdf)
Itulazax (birch pollen extract)
Ivermectin Medical Valley (ivermectin) RMP v.1.0 public summary 28.4.2021 (pdf)
Ivermectine ratiopharm (ivermectine) RMP v.0.1 public summary 31.8.2021 (pdf)
Jardiance (empagliflozin) (pdf)
Jaydess (levonorgestrel) (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)
Klexane (enoxaparin) (pdf)
Kovaltry (octocog alfa) (pdf)
Kyleena (levonorgestrel) (pdf)
Lacosamide Fresenius Kabi (lacosamide) RMP v.0.2 public summary 21.4.2022 (pdf)
Lacosamide Medical Valley (lacosamide) RMP v.1.1 public summary 7.3.2019 (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.1.2 public summary 22.10.2020 (pdf)
Lenalidomide STADA (lenalidomide) RMP v.4.1 public summary 29.9.2020 (pdf)
Lercanidipin Orion (lerkadipine) (pdf)
Lescol (fluvastatin) (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)
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)
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)
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 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.3.1 public summary 4.1.2023 (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 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.1.0 public summary 30.7.2019 (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) (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)
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)
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)
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)
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) (pdf)
OxyContin, OxyNorm (oxycodone) (pdf)
Oxycorion Depot (oxycodone) RMP v.3.0 public summary 5.1.2023 (pdf)
Pabal (carbetocin) (pdf)
Palandra (drospirenone and ethinylestradiol) (pdf)
Paliperidone ratiopharm (paliperidone) RMP v.2.0 public summary 10.12.2020 (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 Orion (pantoprazole) (pdf)
Para-Caps (paracetamol) (pdf)
Paracetamol B. Braun (paracetamol) (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)
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) RMP v.4.0 public summary 13.6.2022 (pdf)
Pregabalin Stada (pregabalin) (pdf)
Priligy (dapoxetine) RMP v.9.0 public summary 25.2.2021 (pdf)
Primovist (gadoxetate) (pdf)
Produodopa (foslevodopa and foscarbidopa) RMP v.1.2 public summary 05.2022 (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.6.1 public summary 16.3.2022 (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)
Ritalin (methylphenidate) (pdf)
Rivaroxaban Krka (rivaroxaban) RMP v.0.4 public summary 20.2.2020 (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)
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)
Sorafenib Stada (sorafenib) (pdf)
Spiriva and Spiriva Respimat (tiotropium) pdf)
Spironolactone Orion (spironolactone) RMP v.1.0 public summary 22.3.2022 (pdf)
Srivasso (tiotropium) (pdf)
Stapressial (Atorvastatin, perindopril and amlodipine) (pdf)
Strattera (atomoxetine) (pdf)
Striverdi Respinat (olodaterol) (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)
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 (tacrolimus) RMP v.0.1 public summary 1.6.2022 (pdf)
Taflotan (tafluprost) (pdf)
Tafluprost Santen (tafluprost) (pdf)
Tadalafil Krka (tadalafil) RMP v.2.0 public summary 10.03.2021 (pdf)
Tadalafil Orion (tadalafil) (pdf)
Tadalafil ratiopharm (tadalafil) (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 Orion (tenofovir disoproxil) (pdf)
Tenofovir disoproxil Stada (tenofovir disoproxil) (pdf)
Teriflunomide Krka (teriflunomide) RMP v.0.3 public summary 26.9.2022 (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 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)
Tisseel and Artiss (fibrin glue) (pdf)
Toctino (alitretinoin) RMP v.11.1 public summary19.6.2019 (pdf)
Topimax (topiramate) (pdf)
Tramadol Krka (tramadol) RMP v.3.0 public summary 17.2.2022 (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 Orion (tranexamic acid) (pdf)
Tranexamic acid Stragen (tranexamic acid) (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)
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 Krka (vardenafil) RMP v.5.5 public summary 5.5.2021 (pdf)
Vargatef (nintedanib) (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)
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 Krka (vildagliptin) RMP v.1.1 public summary 13.6.2017 (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)
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)
Voriconazole Fresenius Kabi (voriconazole) (pdf)
Voriconazole Orion (voriconazole) (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) (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)