For help on how to get the results you want, see our search tips.
27 results
Medicine type
Accelerated assessment Remove Accelerated assessment filter
Exceptional circumstances Remove Exceptional circumstances filter
Biosimilar Remove Biosimilar filter
Conditional approval Remove Conditional approval filter
Orphan medicine Remove Orphan medicine filter
Generic Remove Generic filter
-
List item
Summary of opinion: Nexviadyme
Avalglucosidase alfa, opinion date: 23/07/2021, Positive, Last updated: 02/08/2021 -
List item
Summary of opinion: Sondelbay
teriparatide, opinion date: 27/01/2022, Positive, Last updated: 28/01/2022 -
List item
Summary of opinion: Vildagliptin / Metformin hydrochloride Accord
vildagliptin / metformin hydrochloride, opinion date: 27/01/2022, Positive, Last updated: 28/01/2022 -
List item
Summary of opinion: Dimethyl fumarate Polpharma
dimethyl fumarate, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
List item
Summary of opinion: Amversio
betaine anhydrous, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
List item
Summary of opinion: Sitagliptin Accord
sitagliptin, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
List item
Summary of opinion: Dimethyl fumarate Neuraxpharm
dimethyl fumarate, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
List item
Summary of opinion: Dimethyl fumarate Mylan
dimethyl fumarate, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
List item
Summary of opinion: Carvykti
ciltacabtagene autoleucel, opinion date: 24/03/2022, Positive, Last updated: 25/03/2022 -
List item
Summary of opinion: Kymriah
tisagenlecleucel, opinion date: 24/03/2022, Positive, Last updated: 25/03/2022 -
List item
Summary of opinion: Cabometyx
cabozantinib, opinion date: 24/03/2022, Positive, Last updated: 25/03/2022 -
List item
Summary of opinion: Amifampridine SERB
amifampridine, opinion date: 24/03/2022, Positive, Last updated: 25/03/2022 -
List item
Summary of opinion: Polivy
polatuzumab vedotin, opinion date: 24/03/2022, Positive, Last updated: 25/03/2022 -
List item
Summary of opinion: Ayvakyt
avapritinib, opinion date: 27/01/2022, Positive, Last updated: 28/01/2022 -
List item
Summary of opinion: Lunsumio (new)
mosunetuzumab, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
List item
Summary of opinion: Yescarta (new)
axicabtagene ciloleucel, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
List item
Summary of opinion: Pirfenidone AET (new)
pirfenidone, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
List item
Summary of opinion: Retsevmo (new)
selpercatinib, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
List item
Summary of opinion: Filsuvez (new)
birch bark extract, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
List item
Referral: Rubraca (updated)
rucaparib, associated names: Rubraca, Article 20 procedures
Status: Procedure started, Last updated: 06/05/2022 -
List item
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 -
List item
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 -
List item
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 -
List item
Referral: Lartruvo
olaratumab, associated names: Lartruvo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 19/07/2019, Last updated: 22/08/2019 -
List item
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