For help on how to get the results you want, see our search tips.
26 results
Medicine type
Exceptional circumstances Remove Exceptional circumstances filter
Orphan medicine Remove Orphan medicine filter
Generic Remove Generic filter
Accelerated assessment Remove Accelerated assessment filter
Categories
Human Remove Human filter
-
List item
Summary of opinion: Albrioza
sodium phenylbutyrate, Ursodoxicoltaurine, opinion date: 12/10/2023, Negative, Last updated: 13/10/2023 -
List item
Summary of opinion: Bylvay
odevixibat, 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: Kaftrio
ivacaftor, tezacaftor, elexacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Yorvipath
Palopegteriparatide, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Finlee
dabrafenib, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Loargys
Pegzilarginase, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
List item
Summary of opinion: Rezzayo
rezafungin, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
List item
Summary of opinion: Spexotras (new)
trametinib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
List item
Summary of opinion: Azacitidine Kabi (new)
azacitidine, opinion date: 10/11/2023, Positive, Last updated: 10/11/2023 -
List item
Summary of opinion: Evkeeza (new)
evinacumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
List item
Summary of opinion: Naveruclif (new)
paclitaxel, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
List item
Summary of opinion: Rystiggo (new)
Rozanolixizumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
List item
Summary of opinion: Omjjara (new)
momelotinib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
List item
Summary of opinion: Prevymis
letermovir, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
List item
Summary of opinion: Agamree
Vamorolone, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
List item
Summary of opinion: Takhzyro
lanadelumab, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Referral: Ocaliva (updated)
obeticholic acid, associated names: Ocaliva, Article 20 procedures
Status: Procedure started, Last updated: 10/11/2023 -
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: 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 -
List item
Referral: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)
daclatasvir, dasabuvir, sofosbuvir, ledipasvir, simeprevir, ombitasvir, paritaprevir, ritonavir, associated names: Sovaldi, Olysio, Viekirax, Harvoni, Exviera, Daklinza, Article 20 procedures
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 23/02/2017, Last updated: 09/03/2017 -
List item
Referral: Iclusig
ponatinib, associated names: Iclusig, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 15/01/2015, Last updated: 02/03/2015