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Summary of opinion: Tibsovo
ivosidenib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Tidhesco
ivosidenib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Opzelura
ruxolitinib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Elfabrio
pegunigalsidase alfa, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Vafseo
vadadustat, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Libtayo
cemiplimab, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Rinvoq
upadacitinib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Bekemv
eculizumab, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Hyftor
sirolimus, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Esbriet
pirfenidone, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Akeega
niraparib, abiraterone acetate, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Imcivree
setmelanotide, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022 -
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Summary of opinion: Vegzelma
bevacizumab, opinion date: 23/06/2022, Positive, Last updated: 21/06/2022 -
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Summary of opinion: Newflend ND H9 (new)
turkey herpes virus, strain rHVT/ND expressing Newcastle disease virus, live, opinion date: 23/03/2023, Positive, Last updated: 24/03/2023 -
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Summary of opinion: Comirnaty
tozinameran, riltozinameran and tozinameran, famtozinameran and tozinameran, COVID-19 mRNA Vaccine (nucleoside modified), opinion date: 19/10/2022, Positive, Last updated: 19/10/2022 -
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Referral: Pholcodine-containing medicinal products (updated)
pholcodine, Article 107i procedures
Status: European Commission final decision, opinion/position date: 14/12/2022, EC decision date: 06/03/2023, Last updated: 29/03/2023 -
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Referral: Janus kinase inhibitors (JAKi) (updated)
tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib, associated names: Xeljanz, Cibinqo, Olumiant, Rinvoq, Jyseleca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/01/2023, EC decision date: 10/03/2023, Last updated: 22/03/2023 -
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Referral: Topiramate (updated)
topiramate, Article 31 referrals
Status: Under evaluation, Last updated: 20/03/2023 -
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Referral: Gelisia and associated names (updated)
timolol maleate, associated names: Genoptol, Gelisia, Timolol sifi 1 mg/g gel oftalmico, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/12/2022, EC decision date: 27/02/2023, Last updated: 16/03/2023 -
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Referral: Pseudoephedrine-containing medicinal products (updated)
pseudoephedrine, Article 31 referrals
Status: Procedure started, Last updated: 16/03/2023 -
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Referral: Rambis and associated names (updated)
ramipril, bisoprolol fumarate, associated names: Ralbior, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/12/2022, EC decision date: 15/02/2023, Last updated: 08/03/2023 -
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Referral: Amfepramone-containing medicinal products
amfepramone, associated names: Regenon, Tenuate Retard, Amfepramon-Hormosan, Regenon Retard, Article 31 referrals
Status: European Commission final decision, opinion/position date: 10/11/2022, EC decision date: 13/01/2023, Last updated: 20/01/2023 -
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Referral: Synchron
Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/05/2022, EC decision date: 28/11/2022, Last updated: 16/12/2022 -
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Referral: Nomegestrol and chlormadinone
nomegestrol, chlormadinone, associated names: Zoely, Article 31 referrals
Status: European Commission final decision, opinion/position date: 01/09/2022, EC decision date: 28/11/2022, Last updated: 14/12/2022 -
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Referral: Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome
terlipressin, Article 31 referrals
Status: CMDh final position, opinion/position date: 10/11/2022, Last updated: 22/11/2022