For help on how to get the results you want, see our search tips.
208 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Referrals Remove Referrals filter
Referral status
European Commission final decision Remove European Commission final decision filter
Opinion provided by Committee for Medicinal Products for Human Use Remove Opinion provided by Committee for Medicinal Products for Human Use filter
Referral type
Article 5(11) referrals (prior to January 2010) Remove Article 5(11) referrals (prior to January 2010) filter
Article 30 referrals Remove Article 30 referrals filter
Article 13 referrals Remove Article 13 referrals filter
Article 31 referrals Remove Article 31 referrals filter
Categories
Human Remove Human filter
-
List item
Referral: Hydroxyethyl starch solutions for infusion
hydroxyethyl starch, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/10/2013, EC decision date: 19/12/2013, Last updated: 12/01/2018 -
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: Gadolinium-containing contrast agents
gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide, gadoxetic acid, associated names: Optimark, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/07/2017, EC decision date: 23/11/2017, Last updated: 04/12/2017 -
List item
Referral: Vancomycin-containing medicines
vancomycin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/05/2017, EC decision date: 21/09/2017, Last updated: 17/11/2017 -
List item
Referral: Symbioflor 2
escherichia coli bacteria (cells and autolysate), associated names: Symbioflor E. Coli, Symbioflor® 2, Symbioflor Escherichia, Article 31 referrals
Status: European Commission final decision, EC decision date: 22/06/2017, Last updated: 07/09/2017 -
List item
Referral: Cardioxane
dexrazoxane, Article 13 referrals
Status: European Commission final decision, opinion/position date: 19/07/2017, EC decision date: 19/07/2017, Last updated: 26/07/2017 -
List item
Referral: Vepesid
etoposide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2017, EC decision date: 26/06/2017, Last updated: 14/07/2017 -
List item
Referral: Etopophos
etoposide phosphate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2017, EC decision date: 26/06/2017, Last updated: 14/07/2017 -
List item
Referral: Micro Therapeutic Research
Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/03/2017, EC decision date: 23/06/2017, Last updated: 10/07/2017 -
List item
Referral: Saroten and associated names
amitriptyline, associated names: Saroten Retard, Redomex, Redomex Diffucaps, Saroten Tabs, Saroten retard Tabs, Saroten 2ml, Sarotex, Sarotex Retard, Sarotex Retard 25, Sarotex Retard 50, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 08/05/2017, Last updated: 06/06/2017 -
List item
Referral: Haldol Decanoate and associated names
haloperidol decanoate, associated names: Haldol Decanoat, Haldol Decanoas, Serenase Dekanoat, Serenase Depot, Haldol - Janssen Decanoat Depot, Haldol Decanoato, Haldol Depot, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 28/04/2017, Last updated: 11/05/2017 -
List item
Referral: Haldol and associated names
haloperidol, associated names: Aloperidin, Haldol-Janssen, Serenase, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 28/04/2017, Last updated: 05/05/2017 -
List item
Referral: Dienogest/ethinylestradiol-containing medicinal products indicated in acne
dienogest, ethinyl estradiol, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/01/2017, EC decision date: 22/03/2017, Last updated: 24/03/2017 -
List item
Referral: Lovenox and associated names
enoxaparin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 09/03/2017, Last updated: 22/03/2017 -
List item
Referral: Metformin and metformin-containing medicines
metformin, associated names: Xigduo, Vipdomet, Velmetia, Synjardy, Ristfor, Komboglyze, Jentadueto, Janumet, Icandra (previously Vildagliptin / metformin hydrochloride Novartis), Glubrava, Eucreas, Efficib, Ebymect, Competact, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/10/2016, EC decision date: 12/12/2016, Last updated: 21/12/2016 -
List item
Referral: Pharmaceutics International Inc.
sodium phenylbutyrate, progesterone, dutasteride, colecalciferol, associated names: Ammonaps, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/09/2016, EC decision date: 05/12/2016, Last updated: 14/12/2016 -
List item
Referral: Clenil and associated names
beclometasone dipropionate, associated names: Becloneb, Beclospin and Sanasthmax, Article 30 referrals
Status: European Commission final decision, opinion/position date: 15/09/2016, EC decision date: 11/11/2016, Last updated: 18/11/2016 -
List item
Referral: Semler
Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/07/2016, EC decision date: 22/09/2016, Last updated: 17/11/2016 -
List item
Referral: Durogesic and associated names
fentanyl, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/07/2016, EC decision date: 22/09/2016, Last updated: 19/10/2016 -
List item
Referral: Alkem
Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2016, EC decision date: 08/09/2016, Last updated: 07/10/2016 -
List item
Referral: Levonelle 1500 microgram tablets and associated names
levonorgestrel, Article 13 referrals
Status: European Commission final decision, opinion/position date: 26/05/2016, EC decision date: 01/08/2016, Last updated: 09/08/2016 -
List item
Referral: Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease
beclometasone, budesonide, flunisolide, fluticasone propionate, fluticasone furoate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 28/04/2016, EC decision date: 29/06/2016, Last updated: 15/07/2016 -
List item
Referral: Novantrone and associated names
mitoxantrone, associated names: Elsep, Ralenova, Article 30 referrals
Status: European Commission final decision, opinion/position date: 28/04/2016, EC decision date: 24/06/2016, Last updated: 05/07/2016 -
List item
Referral: Cymevene
ganciclovir, associated names: Cymevan, Citovirax, Article 30 referrals
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 28/04/2016, Last updated: 21/06/2016 -
List item
Referral: Amoxil
amoxicillin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 25/06/2015, EC decision date: 20/08/2015, Last updated: 19/05/2016