For help on how to get the results you want, see our search tips.
225 results
Medicine type
Additional monitoring Remove Additional monitoring filter
Exceptional circumstances Remove Exceptional circumstances filter
Generic Remove Generic filter
Conditional approval Remove Conditional approval filter
Medicine
Paediatric investigation plans Remove Paediatric investigation plans filter
Summaries of opinion Remove Summaries of opinion filter
Referrals Remove Referrals filter
Categories
Human Remove Human filter
-
List item
Summary of opinion: Krazati
adagrasib, opinion date: 20/07/2023, Negative, Last updated: 28/07/2023 -
List item
Summary of opinion: Bylvay
odevixibat, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
List item
Summary of opinion: Tepkinly
epcoritamab, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
List item
Summary of opinion: Degarelix Accord
degarelix acetate, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
List item
Summary of opinion: Revestive
teduglutide, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Refixia
nonacog beta pegol, opinion date: 22/06/2023, Positive, Last updated: 23/06/2023 -
List item
Summary of opinion: Ronapreve
casirivimab, imdevimab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Jaypirca
pirtobrutinib, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Camzyos
mavacamten, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Kaftrio (new)
ivacaftor, tezacaftor, elexacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Ryeqo (new)
relugolix, estradiol, norethisterone acetate, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Voxzogo (new)
vosoritide, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Enhertu (new)
trastuzumab deruxtecan, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Referral: Adakveo
crizanlizumab, associated names: Adakveo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/05/2023, EC decision date: 03/08/2023, Last updated: 29/08/2023 -
List item
Referral: Quinolone- and fluoroquinolone-containing medicinal products
nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin, associated names: Quinsair, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 11/03/2019, Last updated: 08/06/2023 -
List item
Referral: Janus kinase inhibitors (JAKi)
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: 22/05/2023 -
List item
Referral: Rubraca
rucaparib, associated names: Rubraca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 21/07/2022, EC decision date: 21/09/2022, Last updated: 17/10/2022 -
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: 08/07/2022 -
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: Picato
ingenol mebutate, associated names: Picato, Article 20 procedures
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 06/07/2020, Last updated: 16/11/2020 -
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: Lemtrada
alemtuzumab, associated names: Lemtrada, Article 20 procedures
Status: European Commission final decision, opinion/position date: 14/11/2019, EC decision date: 16/01/2020, Last updated: 04/02/2020 -
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: Xofigo
radium Ra223 dichloride, associated names: Xofigo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 26/07/2018, EC decision date: 28/09/2018, Last updated: 11/10/2018 -
List item
Referral: Zinbryta
associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, EC decision date: 27/03/2018, Last updated: 11/07/2018