Summaries of risk management plans

Translations of RMP summaries in Finnish and Swedish are required to be submitted for medicinal products authorised by national, mutual recognition and decentralised procedures. For centrally authorised products, translations of RMP summaries are recommended to be submitted only from RMP summaries published by the European Medicines Agency.

Fimea publishes on its website summaries of risk management plans, the English version approved by the Authority and the Finnish and Swedish translations prepared by the marketing authorisation holder. Responsibility for the content of the translations belongs to the marketing authorisation holder.
 

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

Abasaglar (insulin glargine) (pdf)

Abilify (aripiprazole) (pdf)

Abstral (fentanyl) (pdf)

Acarizax (dermatophagoides farinae, dermatophagoides pteronyssinus) (pdf)

Actilyse (alteplase) (pdf)

Adempas (riociguat) (pdf)

Adrenalin Stragen (adrenaline) (pdf)

Afamcivir (famciclovir) (pdf)

Albuman (human albumin) (pdf)

Alendronat ratiopharm (alendronic acid) (pdf)

Alendronat Bluefish (alendronic acid) (pdf)

Alfuzosin hydrochloride Orion (alfuzosin) (pdf)

Allegra (fexofenadine) (pdf)

Amiodarone Orion (amiodarone) (pdf)

Amlodipin Pfizer (amlodipine) (pdf)

Amorion Comp (amoxicillin and clavulanic acid) (pdf)

Arcoxia (etoricoxib) (pdf)

Aripiprazol Krka (aripiprazole) (pdf)

Aripiprazol Stada (aripiprazole) (pdf)

Aripiprazole Orion (aripiprazole) (pdf)

Aripiprazole ratiopharm (aripiprazole) (pdf)

Avelox (moxifloxacin) (pdf)

Azotorion (azithromycin) (pdf)

Bendamustine Fresenius Kabi (bendamustine) (pdf)

Benelyte (solution for infusion) (pdf)

Bimatoprost Stada (bimatoprost) (pdf)

Bisolaclar (acetylcysteine) (pdf)

Blincyto (blinatumomab) (pdf)

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

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

Botox and Vistabel (botulinumtoxinA) (pdf)

Breakyl (fentanyl) (pdf)

Brevibloc (esmolol) (pdf)

Brinzolamide ratiopharm (brinzolamide) (pdf)

Briviact (brivaracetam) (pdf)

Budesonide Teva (budesonide) (pdf)

Bufomix Easyhaler (budesonide and formoterol) (pdf)

Bupropion Orion (bupropion) (pdf)

Burana (ibuprofen) (pdf)

Calciumfolinat Fresenius Kabi (calcium folinate) (pdf)

Candesartan HCTZ Actavis (candesartan and hydrochlorothiazide) (pdf)

Candesartan HCTZ Orion (candesartan and hydrochlorothiazide) (pdf)

Cartexan (chondroitin sulfate) (pdf)

Casodex (bicalutamide) (pdf)

Caspofungin Stada (caspofungin) (pdf)

Cerdelga (eliglustat) (pdf)

Certican (everolimus) (pdf)

Cimzia (TNFα blocker) (pdf)

Ciprofloxacin Orion (ciprofloxacin) (pdf)

Ciqorin (ciclosporin) (pdf)

Cinacalcet ratiopharm (cinacalcet) (pdf)

Cinryze (C1 inhibitor) (pdf)

Clarityn (loratadine) (pdf)

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

Cofact (clotting factors II, VII, IX and X) (pdf)

Colrefuz (colchicine) (pdf)

Cortiment (budesonide) (pdf)

Cosentyx (secukinumab) (pdf)

Cotellic (cobimetinib) (pdf)

Cozaar (losartan) (pdf)

Creon (pancreatin) (pdf)

Cypretyl (cyproteroneacetate and ethinylestradiol) (pdf)

Cyramza (ramucirumab) (pdf)

Dacepton (apomorphine) (pdf)

Daklinza (daclatasvir) (pdf)

Dalacin (clindamycin) (pdf)

Desloratadine Actavis (desloratadine) (pdf)

Detremin (cholecalciferol) (pdf)

Divisun (colecalciferol) (pdf)

Docetaxel Orion (docetaxel) (pdf)

Duavive (conjugated oestrogens and bazedoxifene) (pdf)

Duloxetine Orion (duloxetine) (pdf)

Duloxetine ratiopharm (duloxetine) (pdf)

Duloxetin Stada (duloxetine) (pdf)

Duosol (solution for haemofiltration) (pdf)

Dutrebis (lamivudine and raltegravir) (pdf)

Efexor Depot (venlafaxine) (pdf)

Elaprase (idursulfase) (pdf)

Elidel (pimecrolimus) (pdf)

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

EpiPen (epinephrine) (pdf)

Eposin (etoposide) (pdf)

Escitalopram Krka (escitalopram) (pdf)

Escitalopram Lundbeck (escitalopram) (pdf)

Escitalopram Orion (escitalopram) (pdf)

Etoricoxib Orion (etoricoxib) (pdf)

Etoricoxib Stada (etoricoxib) (pdf)

Evotaz (atazanavir and cobicistat) (pdf)

Exviera (dasabuvir) (pdf)

Ezetrol (ezetimibe) (pdf)

Femar (letrozole) (pdf)

Femoston (estradiol and dydrogesterone) (pdf)

Fenylefrin Stragen (phenylephrine) (pdf)

Fexorin (fexofenadine) (pdf)

Fibclot (fibrinogen) (pdf)

Finasteride Bluefish (finasteride) (pdf)

Flecainide Orion (flecainide) (pdf)

Flexyess (Drospirenone and ethinylestradiol) (pdf)

Fluarix (influenza vaccine) (pdf)

Flucloxacillin Orion (flucloxacillin) (pdf)

Fludarabin Actavis (fludarabine) (pdf)

Fredomat (travoprost) (pdf)

Gazyvaro (obinutuzumab) (pdf)

Gemkabi (gemcitabine) (pdf)

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

Geloplasma (solution for infusion) (pdf)

Giotrif (afatinib) (pdf)

Granocyte (lenograstim) (pdf)

Harvoni (ledipasvir and sofosbuvir) (pdf)

Histec (cetirizine) (pdf)

Hydrocortisone Orion (hydrocortisone) (pdf)

Hydrokortison CCS (hydrocortisone) (pdf)

Ibandronate ratiopharm (ibandronic acid) (pdf)

Ibandronat Stada (ibandronic acid) (pdf)

Ikervis (ciclosporin) (pdf)

Imatinib Fresenius Kabi (imatinib) (pdf)

Imatinib Stada (imatinib) (pdf)

Imbruvica (ibrutinib) (pdf)

Imlygic (talimogene laherparepvec) (pdf)

Imodium (loperamide) (pdf)

Incresync (alogliptin and pioglitazone) (pdf)

Incruse (umeclidinium bromide) (pdf)

Inegy (ezetimibe and simvastatin) (pdf)

Influvac (influenza vaccine) (pdf)

Inspiolto Respimat (tiotropium and olodaterol) (pdf)

Intuniv (guanfacine) (pdf)

Isotretinoin Actavis (isotretinoin) (pdf)

Jardiance (empagliflozin) (pdf)

Jaydess (levonorgestrel) (pdf)

Jinarc (tolvaptan) (pdf)

Kadcyla (trastuzumab) (pdf)

Ketipinor (quetiapine) (pdf)

Kovaltry (octocog alfa) (pdf)

Keytruda (pembrolizumab) (pdf)

Kyprolis (carfilzomib) (pdf)

Lamictal (lamotrigine) (pdf)

Latanoprost Pfizer (latanoprost) (pdf)

Leflunomide Stada (leflunomide) (pdf)

Lemilvo (aripiprazole) (pdf)

Lescol (fluvastatin) (pdf)

Letrozol Orion (letrozole) (pdf)

Levocetirizin Orion (levocetirizine) (pdf)

Levocetirizin Stada (levocetirizine) (pdf)

Levofloxacin Orion (levofloxacin) (pdf)

Linatera (Drospirenone and ethinylestradiol) (pdf)

Linezolid Orion (linezolid) (pdf)

Liofora (Drospirenone and ethinylestradiol) (pdf)

Lipistad (atorvastatin) (pdf)

Lipoplus (intravenous infusion) (pdf)

Liporion (atorvastatin) (pdf)

Lisinopril/Hydrochlorothiazide Orion (lisinopril and hydrochlorothiazide) (pdf)

Losatrix (losartan) (pdf)

Lutinus (progesterone) (pdf)

Lynparza (olaparib) (pdf)

Medipekt (bromhexine) (pdf)

Meditus (acetylcysteine) (pdf)

Melatonin Orion (melatonin) (pdf)

Melatonin Vitabalans (melatonin) (pdf)

Memantin Stada (memantine) (pdf)

Menjugate (meningococcal vaccine) (pdf)

Menopur (menotrophin) (pdf)

Metadon Abcur (methadone) (pdf)

Metadon Nordic Drugs (methadone) (pdf)

Methotrexate Orion (methotrexate) (pdf)

Methylphenidate Actavis (methylphenidate) (pdf)

Metoclopramide Orion (metoclopramide) (pdf)

Minirin (desmopressin) (pdf)

Mirtazapin Orion (mirtazapine) (pdf)

Modafinil Orion (modafinil) (pdf)

Mometasone Actavis (mometasone) (pdf)

Moventig (naloxegol) (pdf)

Movicol Junior Plain (macrogol 3350) (pdf)

Moxifloxacin Orion (moxifloxacin) (pdf)

Naproxen Orion (naproxen) (pdf)

Nasacort (triamcinolone acetonide) (pdf)

Neofordex (dexamethasone) (pdf)

Neotigason (acitretin) (pdf)

Neupogen (filgrastim) (pdf)

Nexium (esomeprazole) (pdf)

Nexplanon (etonogestrel) (pdf)

Nicorette (nicotine) (pdf)

Nicorette Pepparmint (nicotine) (pdf)

Noviana (oestrogen) (pdf)

Nucala (mepolizumab) (pdf)

Nulojix (belatacept) (pdf)

Numeta (parenteral nutrition) (pdf)

NuvaRing (etonogestrel and ethinylestradiol) (pdf)

Octostim (desmopressin) (pdf)

Ofev (nintedanib) (pdf)

Olanzapin Orion (olanzapine) (pdf)

Olanzapine ratiopharm (olanzapine) (pdf)

Olmesartan medoxomil (olmesartan) (pdf)

Olmestad Comp (olmesartan and hydrochlorothiazide) (pdf)

Olysio (simeprevir) (pdf)

Orencia (abatacept) (pdf)

Oridip (lercanidipine) (pdf)

Orisild (sildenafil) (pdf)

Orudis 2.5% gel (etoprofen)(pdf)

Otrivin Comp (ipratropium and xylometazoline) (pdf)

Oxycodone Orion (oxycodone) (pdf)

Oxycodone ratiopharm (oxycodone) (pdf)

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

OxyContin, OxyNorm (oxycodone) (pdf)

Palandra (drospirenone and ethinylestradiol) (pdf)

Palonosetron Fresenius Kabi (palonosetron) (pdf)

Palonosetron Stada (palonosetron) (pdf)

Pamol (paracetamol) (pdf)

Pamolhot-C (paracetamol and ascorbic) (pdf)

Para-Caps (paracetamol) (pdf)

Paracetamol B. Braun (paracetamol) (pdf)

Pemetrexed Fresenius Kabi (pemetrexed) (pdf)

Pemetrexed Stada (pemetrexed) (pdf)

Pentiro (entacapone, levodopa and carbidopa) (pdf)

Physioneal (peritoneal dialysis solution) (pdf)

Picorion (sodium picosulfate) (pdf)

Plasmalyte (crystalloid solution for intravenous infusion) (pdf)

Plenadren (hydrocortisone) (pdf)

Portrazza (necitumumab) (pdf)

Praluent (Alirocumab)(pdf)

Pramipexol Stada (pramipexole) (pdf)

Pravorion (pravastatin) (pdf)

Praxbind (idarucizumab) (pdf)

Prednisolon Alternova (prednisolon) (pdf)

Pregabalin Krka (pregabalin) (pdf)

Pregabalin Orion (pregabalin) (pdf)

Pregabalin Pfizer (pregabalin) (pdf)

Pregabalin Stada (pregabalin) (pdf)

Primovist (Gadoxetate)(pdf)

Pronaxen (naproxen) (pdf)

Proscar (finasteride) (pdf)

Prothromplex (prothrombin complex coagulation factors) (pdf)

Raplixa (fibrinogen and thrombin) (pdf)

Rasagilin Stada (rasagiline (pdf)

Rasagilin Stada Arzneimittel AG (rasagiline) (pdf)

Rasagiline Orion (rasagiline) (pdf)

Remeron SolTab (mirtazapine) (pdf)

Rennie Orange (calsium carbonate and magnesium subcarbonate) (pdf)

Repatha (evolocumab) (pdf)

Resolor (prucalopride) (pdf)

Revestive (teduglutide) (pdf)

Rezolsta (darunavir and cobicistat) (pdf)

Risperdal and Risperdal Consta (risperidone) (pdf)

Ristempa (pegfilgrastim) (pdf)

Ritalin (methylphenidate) (pdf)

Rosuvastatin ratiopharm (rosuvastatin) (pdf)

Rosuvastatin Stada (rosuvastatin) (pdf)

Saxenda (liraglutide) (pdf)

Serdolect (sertindole) (pdf)

Seretide (salmeterol and fluticasone) (pdf)

Sidenafil Pfizer / Viagra (sildenafil) (pdf)

Sirturo (bedaquiline) (pdf)

Sivextro (tedizolid)(pdf)

Skudex (dexketoprofen and tramadol) (pdf)

SmofKabiven (emulsion for infusion) (pdf)

Spiriva and Spiriva Respimat (tiotropium bromide) (pdf)

Strattera (atomoxetine) (pdf)

Striverdi Respinat (olodaterol) (pdf)

Sylvant (siltuximab) (pdf)

Symbicort Turbuhaler (budesonide and formoterol) (pdf)

Synjardy (empagliflozin and metformin) (pdf)

Taflotan (tafluprost) (pdf)

Tadalafil Orion (tadalafil) (pdf)

Taptiqom (tafluprost and timolol) (pdf)

Targiniq (oxycodone and naloxone) (pdf)

Targocid (teicoplanin) (pdf)

Telfast (fexofenadine) (pdf)

Telmisartan HCTZ ratiopharm (Telmisartan and hydrochlorothiazide) (pdf)

Tenofovir Disoproxil Stada (tenofovir disoproxil) (pdf)

TicoVac and TicoVac Junior (TBE vaccination) (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)

Triumeq (dolutegravir, abacavir and lamivudine) (pdf)

Trexan (methotrexate) (pdf)

Trulicity (dulaglutide) (pdf)

Valganciklovir Teva (valganciclovir) (pdf)

Valsartan Hydrochlorothiazide Orion (valsartan and hydrochlorothiazide) (pdf)

Valsartan Orion (valsartan) (pdf)

Vancomycin Orion (vancomycin) (pdf)

Vargatef (nintedanib) (pdf)

Vectatone (penciclovir) (pdf)

Vectibix (panitumumab) (pdf)

Venlafaxin Pfizer (venlafaxine) (pdf)

Venorion (venlafaxine) (pdf)

Viekirax (ombitasvir, paritaprevir and ritonavir) (pdf)

Vipdomet (alogliptin and metformin) (pdf)

Vipidia (alogliptin) (pdf)

Voluven (HES and sodium chloride) (pdf)

Voriconazole Fresenius Kabi (voriconazole) (pdf)

Voriconazole Orion (voriconazole) (pdf)

Voxra (bupropion) (pdf)

VPRIV (velaglucerase alfa) (pdf)

Vreya (cypromix) (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)

Zavedos (idarubicin) (pdf)

Zerbaxa (ceftolozane and tazobactam) (pdf)

Zofran (ondansetron) (pdf)

Zoledronic Acid Agila (zoledronic acid) (pdf)

Zontivity (vorapaxar) (pdf)

Zyban (bupropion) (pdf)

Zydelig (idelalisib) (pdf)