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15 results
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Summary of opinion: Zynlonta
loncastuximab tesirine, opinion date: 15/09/2022, Positive, Last updated: 19/09/2022 -
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Summary of opinion: Pyrukynd
mitapivat, opinion date: 15/09/2022, Positive, Last updated: 16/09/2022 -
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Summary of opinion: Yescarta
axicabtagene ciloleucel, opinion date: 15/09/2022, Positive, Last updated: 16/09/2022 -
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Summary of opinion: Ebvallo
tabelecleucel, opinion date: 13/10/2022, Positive, Last updated: 14/10/2022 -
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Summary of opinion: Pemetrexed Baxter
pemetrexed, opinion date: 13/10/2022, Positive, Last updated: 14/10/2022 -
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Summary of opinion: Livmarli
Maralixibat chloride, opinion date: 13/10/2022, Positive, Last updated: 14/10/2022 -
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Summary of opinion: Dimethyl fumarate Teva
dimethyl fumarate, opinion date: 13/10/2022, Positive, Last updated: 14/10/2022 -
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Summary of opinion: Plerixafor Accord
plerixafor, opinion date: 13/10/2022, Positive, Last updated: 18/10/2022 -
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Summary of opinion: Pirfenidone Viatris (new)
pirfenidone, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022 -
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Summary of opinion: Sugammadex Amomed (new)
sugammadex, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022 -
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Summary of opinion: Imcivree
setmelanotide, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022 -
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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: 08/07/2022 -
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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: 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