Supervision

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 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)

Afamcivir (famciclovir) (pdf)

Agomelatine Anpharm (agomelatine) RMP v.24.0 public summary 22.10.2020 (pdf)

Agomelatine ratiopharm (agomelatine) (pdf)

Albiomin (albumin) (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)

Ambrisentan Accord (ambrisentan) (pdf)

Amiodarone Orion (amiodarone) (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)

Arcoxia (etoricoxib) (pdf)

Aripiprazol Krka (aripiprazole) (pdf)

Aripiprazol Stada (aripiprazole) (pdf)

Aripiprazol Stada (aripiprazole oral solution) (pdf)

Aripiprazole Orion (aripiprazole) (pdf)

Aripiprazole ratiopharm (aripiprazole) (pdf)

Asmanex Twisthaler (mometasone) (pdf)

Astarior (atorvastatin and perindopril) (pdf)

Atomoxetin Orion (atomoxetine) (pdf)

Atorvastatin Pfizer (atorvastatin) (pdf)

Atosiban Ever Pharma (atosiban) (pdf)

Atosiban Stragen (atosiban) (pdf)

Avelox (moxifloxacin) (pdf)

Azacitidine Stada (azacitidine) (pdf)

Azotorion (azithromycin) (pdf)

Azyter (azithromycin) (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)

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)

Boostrix (booster vaccination against diphtheria, tetanus and pertussis) (pdf)

Boostrix Polio (booster vaccination against diphtheria, tetanus, poliomyelitis and pertussis) (pdf)

Bortezomib EVER Pharma (bortezomib) RMP v.0.3 public summary 15.7.2021 (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 (botulinumtoxinA) (pdf)

Breakyl (fentanyl) (pdf)

Brevibloc (esmolol) (pdf)

Brinzolamide ratiopharm (brinzolamide) (pdf)

Briviact (brivaracetam) (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)

Calcichew (calcium carbonate and cholecalciferol) (pdf)

Calciumfolinat Fresenius Kabi (calcium folinate) (pdf)

Calciumgluconat B.Braun (calcium gluconate) (pdf)

Candesartan HCTZ Actavis (candesartan and hydrochlorothiazide) (pdf)

Candesartan HCTZ Orion (candesartan and hydrochlorothiazide) (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) (pdf)

Caspofungin Stada (caspofungin) RMP v.1.1 public summary 10.12.2020 (pdf)

Cefuroxim B.Braun (cefuroxime) (pdf)

Celebra (celecoxib) RMP v.4.0 public summary 5.10.2017 (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)

Clarityn (loratadine) (pdf)

Cleodette, Cleonita, Cleosensa (drospirenone and ethinylestradiol) (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) (pdf)

Concerta (methylphenidate) (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)

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)

Daptomycin Stada (daptomycin) (pdf)

Darunavir Stada (darunavir) (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)

Dexamethasone phosphate Kabi (dexamethasone) RMP v.3.1 public summary 27.10.2020 (pdf)​

Dexdor (dexmedetomidine) (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)

Diovan (valsartan) (pdf)

Divisun (colecalciferol) (pdf)

Docetaxel Orion (docetaxel) (pdf)

Doneprion (donepezil hydrochloride) (pdf)

Duavive (conjugated oestrogens and bazedoxifene) (pdf)

Ducressa (dexamethasone and levofloxacin) (pdf)

Duloxetine Orion (duloxetine) RMP v.2.0 public summary 19.11.2020 (pdf)

Duloxetine ratiopharm (duloxetine) (pdf)

Duloxetin Stada (duloxetine) (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 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)

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)

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 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 Orion (etoricoxib) (pdf)

Etoricoxib ratiopharm (etoricoxib) (pdf)

Etoricoxib Stada (etoricoxib) (pdf)

Euvascor (atorvastatin and perindopril) (pdf)

Extraneal (peritoneal dialysis solution) (pdf)

Exviera (dasabuvir) (pdf)

Ezetimib Stada (ezetimibe) (pdf)

Ezetrol (ezetimibe) (pdf)

Faberka (tadalafil) (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 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)

Fluarix (influenza vaccine) (pdf)

Flucloxacillin Orion (flucloxacillin) RMP v.2.0 public summary 9.2.2021 (pdf)

Fluconazol Vitabalans (fluconazole) RMP v.0.1 public summary 17.6.2020 (pdf)

Fludarabin Actavis (fludarabine) (pdf)

Fluorescite (fluorescein sodium) (pdf)

Folic Acid Vitabalans (folic acid) (pdf)

Fosastad (alendronate and colecalciferol) (pdf)

Fosfomycin Infectopharm (fosfomycin) (pdf)

Fosrenol (lanthanum) RMP v. 9.0 public summary 12.9.2018 (pdf)

Fredomat (travoprost) (pdf)

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

Gabapentin Orion (film-coated tablets) (gabapentin) (pdf)

Gabapentin Orion (hard capsules) (gabapentin) (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)

Granocyte (lenograstim) (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) (pdf)

Hydrocortisone Orion (hydrocortisone) (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 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)

Inegy (ezetimibe and simvastatin) (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)

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.2.0 public summary 15.2.2018 (pdf)

Klexane (enoxaparin) (pdf)

Kovaltry (octocog alfa) (pdf)

Kyleena (levonorgestrel) (pdf)

Lamictal (lamotrigine) (pdf)

Latanoprost Pfizer (latanoprost) RMP v.5.0 public summary 2.2.2017 (pdf)

Leflunomide Stada (leflunomide) (pdf)

Lemilvo (aripiprazole) (pdf)

Lenalidomide Fresenius Kabi (lenalidomide) RMP v.1.0 public summary 7.12.2021 (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 Orion (levofloxacin) (pdf)

Levomepromazine Orion (levomepromazine) (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)

Linagliptin STADA (linagliptin) RMP v.1.0 public summary 9.1.2020 (pdf)

Linatera (Drospirenone and ethinylestradiol) (pdf)

Linezolid Accord (linetsolid) (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) (pdf)

Livial (tibolone) (pdf)

Longin kirsikka (benzydamine hydrochloride) (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)

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)

Metadon Abcur (methadone) (pdf)

Metadon Nordic Drugs (methadone) (pdf)

Methotrexat Accord (methotrexate) (pdf)

Methotrexate Orion (methotrexate) RMP v.3.1 public summary 4.6.2020 (pdf)

Methotrexate Pfizer (methotrexate) RMP v.0.3 public summary 14.10.2020 (pdf)

Methylphenidate Actavis (methylphenidate) (pdf)

Methylphenidate Orion (methylphenidate) (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)

Midazolam Accordpharma (midazolam) RMP v.1.2 public summary 15.5.2020 (pdf)

Milnocor (milrinone) (pdf)

Minirin (desmopressin) (pdf)

Mirena (levonogestrel) RMP v.1.2 public summary 5.3.2020 (pdf)

Mirtazapin Orion (mirtazapine) (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 Orion (moxifloxacin) (pdf)

Mucoratio (acetylcysteine) (pdf)

Mydrane (tropicamide, phenylephrine and lidocaine) RMP v.4.0 public summary 30.1.2020 (pdf)

Myfortic (mycophenolic acid) (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)

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)

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 (olmesartan) (pdf)

Olmestad Comp (olmesartan and hydrochlorothiazide) (pdf)

Olysio (simeprevir) (pdf)

Omeprazol Orion (Omeprazole) (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 Orion (oxycodone) (pdf)

Oxycodone ratiopharm (oxycodone) (pdf)

Oxycodone/Naloxone Acino (oxycodone and naloxone) (pdf)

Oxycodone/Naloxone Stada (oxycodone and naloxone) (pdf)

OxyContin, OxyNorm (oxycodone) (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)

Pazopanib Stada (pazopanib) RMP v.0.5 public summary 9.12.2021 (pdf)

Pegorion (macrogol 4000) (pdf)

Pemetrexed Fresenius Kabi (pemetrexed) (pdf)

Pemetrexed Orion (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)

Physioneal (peritoneal dialysis solution) (pdf)

Picorion (sodium picosulfate) (pdf)

Pirfenidone ratiopharm (pirfenidone) RMP v.1.2 public summary 10.1.2022 (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) (pdf)

Pregabalin Orion (pregabalin) (pdf)

Pregabalin Stada (pregabalin) (pdf)

Priligy (dapoxetine) RMP v.9.0 public summary 25.2.2021 (pdf)

Primovist (gadoxetate) (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 Orion (quetiapine fumarate) RMP 2.0 public summary 25.11.2020 (pdf)

Quetiapin ratiopharm (quetiapine) (pdf)

Raplixa (fibrinogen and thrombin) (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)

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 ratiopharm (rivaroxaban) RMP v.1.1 public summary 4.12.2019 (pdf)

Rivastigmin ratiopharm (rivastigmine) (pdf)

Rivastor (rivastigmine) (pdf)

Rocuronium Fresenius Kabi (rocuronium) RMP v.0.1 public summary 8.3.2021 (pdf)

Rosuvastatin Actavis (rosuvastatin) (pdf)

Rosuvastatin Orion (rosuvastatin) RMP v.1.0 public summary 10.7.2021 (pdf)

Rosuvastatin ratiopharm (rosuvastatin) (pdf)

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

Rosuvastatin Stada (rosuvastatin) (pdf)

Salflumix Easyhaler (salmeterol and fluticasone) RMP v.2.0 public summary 25.11.2020 (pdf)

Saxenda (liraglutide) (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 STADA (sitagliptin) RMP v.1.1 public summary 23.7.2020 (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)

Sivextro (tedizolid) (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) (pdf)

Solifenacin Orion (solifenacin) (pdf)

Solifenacin Stada (solifenacin) (pdf)

Sorafenib Stada (sorafenib) (pdf)

Spiriva and Spiriva Respimat (tiotropium) pdf)

Srivasso (tiotropium) (pdf)

Stapressial (Atorvastatin, perindopril and amlodipine) (pdf)

Strattera (atomoxetine) (pdf)

Striverdi Respinat (olodaterol) (pdf)

Sunosi (solriamfetol hydrochloride) (pdf)

Suxamethonium Ethypharm (suxamethonium chloride) (pdf)

Sylvant (siltuximab) (pdf)

Symbicort Turbuhaler (budesonide and formoterol) (pdf)

Synjardy (empagliflozin and metformin) (pdf)

Taflotan (tafluprost) (pdf)

Tafluprost Santen (tafluprost) (pdf)

Tadalafil Orion (tadalafil) (pdf)

Tadalafil ratiopharm (tadalafil) (pdf)

Takhzyro (lanadelumab) (pdf)

Tamsurion (tamsulosin) (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)

Tetraspan and Venofundin (HES solution) (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) (pdf)

Topimax (topiramate) (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) (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)

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) (pdf)

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

Viekirax (ombitasvir, paritaprevir and ritonavir) (pdf)

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

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) (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)

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

Zavedos (idarubicin) (pdf)

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

Zerbaxa (ceftolozane and tazobactam) (pdf)

Zevtera (ceftobiprole) (pdf)

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

Zofran (ondansetron) (pdf)

Zoledronic Acid Agila (zoledronic acid) (pdf)

Zomacton (somatropin) (pdf)

Zontivity (vorapaxar) (pdf)

Zopiclone Orion (zopiclone) (pdf)

Zyban (bupropion) (pdf)

Zydelig (idelalisib) (pdf)

Zysils (benzydamine) (pdf)