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281 results
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Summary of opinion: Albrioza
sodium phenylbutyrate, Ursodoxicoltaurine, opinion date: 12/10/2023, Negative, Last updated: 13/10/2023 -
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Summary of opinion: Bylvay
odevixibat, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
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Summary of opinion: Revestive
teduglutide, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Adcetris
brentuximab vedotin, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Kaftrio
ivacaftor, tezacaftor, elexacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Yorvipath
Palopegteriparatide, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Finlee
dabrafenib, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Loargys
Pegzilarginase, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Rezzayo
rezafungin, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Spexotras (new)
trametinib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Azacitidine Kabi (new)
azacitidine, opinion date: 10/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Evkeeza (new)
evinacumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Naveruclif (new)
paclitaxel, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Rystiggo (new)
Rozanolixizumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Omjjara (new)
momelotinib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Prevymis
letermovir, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Agamree
Vamorolone, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Takhzyro
lanadelumab, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Referral: Ocaliva (updated)
obeticholic acid, associated names: Ocaliva, Article 20 procedures
Status: Procedure started, Last updated: 10/11/2023 -
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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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Orphan designation: Talquetamab for: Treatment of multiple myeloma
Date of designation: 20/08/2021, Positive, Last updated: 21/09/2023 -
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Orphan designation: Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-methoxy, ether with N-[[[2-[[6-[[1-[3-[[3-(2,3-dihydroxypropoxy)propyl]amino]-3-oxopropyl]-2,5-dioxo-3-pyrrolidinyl]thio]hexyl]amino]ethyl]amino]carbonyl]-2-methylalanyl-teriparatide (2:1) for: Treatment of hypoparathyroidism
Date of designation: 19/10/2020, Positive, Last updated: 15/09/2023