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120 results
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Summary of opinion: Nexviadyme
Avalglucosidase alfa, opinion date: 23/07/2021, Positive, Last updated: 02/08/2021 -
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Summary of opinion: Amversio
betaine anhydrous, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
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Summary of opinion: Sitagliptin Accord
sitagliptin, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
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Summary of opinion: Yescarta
axicabtagene ciloleucel, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Pirfenidone AET
pirfenidone, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Filsuvez
birch bark extract, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Kinpeygo
budesonide, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Zokinvy
lonafarnib, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Upstaza
eladocagene exuparvovec, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Ertapenem SUN
ertapenem, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Sugammadex Fresenius Kabi
sugammadex, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Accord
sitagliptin, metformin hydrochloride, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Ganirelix Gedeon Richter
ganirelix, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Xenpozyme
olipudase alfa, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Pepaxti (new)
melphalan flufenamide, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Summary of opinion: Vyvgart (new)
efgartigimod alfa, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Summary of opinion: Scemblix (new)
asciminib, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Summary of opinion: Crysvita (new)
burosumab, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Summary of opinion: Roctavian (new)
Valoctocogene roxaparvovec, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Referral: Zynteglo
betibeglogene autotemcel, associated names: Zynteglo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 22/07/2021, EC decision date: 16/09/2021, Last updated: 11/10/2021 -
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan, olmesartan, associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 19/02/2021, Last updated: 19/03/2021 -
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Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products
capecitabine, fluorouracil, tegafur, flucytosine, associated names: Xeloda, Teysuno, Capecitabine Accord, Capecitabine Medac, Capecitabine Teva, Ecansya (previously Capecitabine Krka), Article 31 referrals
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 07/07/2020, Last updated: 23/07/2020 -
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Referral: Factor VIII
associated names: Iblias, Elocta, Kovaltry, Nuwiq, Obizur, NovoEight, Voncento, ReFacto AF, Kogenate Bayer, Helixate NexGen, Advate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/09/2017, EC decision date: 10/10/2017, Last updated: 05/12/2017 -
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Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014 -
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Direct healthcare professional communication (DHPC): Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy
Active substance: onasemnogene abeparvovec, DHPC type: Type II variation, Last updated: 18/03/2021