79 results
-
List item
Referral: Bicalutamide 150 mg
bicalutamide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/05/2007, EC decision date: 03/09/2007, Last updated: 03/10/2007Bicalutamide 150 mg … Bicalutamide 150 mg … QUESTIONS AND ANSWERS ON BICALUTAMIDE 150 MG TABLETS Following … -
List item
Referral: Bicaluplex
bicalutamide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/09/2007, EC decision date: 22/11/2007, Last updated: 07/02/2008Non-Proprietary Name (INN): bicalutamide: Background information (PDF/31.41 … and associated names, INN-bicalutamide European Medicines … Non-Proprietary Name (INN): bicalutamide BACKGROUND INFORMATION … -
List item
Press release: EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision; Aurobindo Pharma stopped from supplying irbesartan to the EU
Last updated: 15/10/2018under increased supervision; Aurobindo Pharma stopped from supplying … under increased supervision; Aurobindo Pharma stopped from supplying … -
List item
National expert: Maria Formosa Cassar, Medicines Authority (updated)
- Declaration of interests - 80.33 KB | PDF
- Curriculum Vitae - 21.4 KB | PDF
Authorisations (pertaining to MAH: Aurobindo Pharma Malta) and PV documentation … -
List item
National expert: Kristian Wennmalm, Medical Products Agency (updated)
- Declaration of interests - 81.09 KB | PDF
- Curriculum Vitae - 19.56 KB | PDF
2011; academic (Docetaxel, Bicalutamide). 2.11 CAT member or alternate … -
List item
Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 24-27 July 2006
CHMP, Last updated: 28/07/2006bicalutamide 150 mg … a referral procedure for bicalutamide 150 mg-containing medicinal … following suspension of Casodex (bicalutamide) 150 mg, from AstraZeneca … -
List item
National expert: Ana Isabel Terleira Fernandez, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 86.19 KB | PDF
- Curriculum Vitae - 31.28 KB | PDF
02/2004-03/2004 Tecnimede Bicalutamide Antiandrogenic 09/2009-10/2009 … -
List item
National expert: Wilhelmus Petrus Johannes (Wim) Witjes, European Medicines Agency (updated)
- Declaration of interests - 82.13 KB | PDF
- Curriculum Vitae - 40.76 KB | PDF
-
List item
Human medicine European public assessment report (EPAR): Xtandi (updated)
enzalutamide, Prostatic Neoplasms
Date of authorisation: 21/06/2013,
Date of refusal: 26/04/2013, Revision: 16, Authorised, Last updated: 24/02/2021 -
List item
Human medicine European public assessment report (EPAR): Lojuxta
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,
, 
, Revision: 13, Authorised, Last updated: 27/01/2021
-
List item
Human medicine European public assessment report (EPAR): Actelsar HCT
telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013,
, Revision: 12, Authorised, Last updated: 27/01/2021
-
List item
Human medicine European public assessment report (EPAR): Erleada
apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019,, Revision: 2, Authorised, Last updated: 17/12/2020
-
List item
Human medicine European public assessment report (EPAR): Mysildecard (updated)
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016,, Revision: 3, Authorised, Last updated: 15/02/2021
-
List item
Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,
, Revision: 23, Authorised, Last updated: 21/12/2020
-
List item
Human medicine European public assessment report (EPAR): Xofigo
radium (223Ra) dichloride, Prostatic Neoplasms
Date of authorisation: 13/11/2013,, Revision: 11, Authorised, Last updated: 18/05/2020
-
List item
Human medicine European public assessment report (EPAR): Firmagon
degarelix, Prostatic Neoplasms
Date of authorisation: 17/02/2009, Revision: 16, Authorised, Last updated: 29/09/2020 -
List item
Human medicine European public assessment report (EPAR): Provenge
autologous peripheral-blood mononuclear cells including a minimum of 50 million autologous CD54+ cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor, Prostatic Neoplasms
Date of authorisation: 06/09/2013,, Revision: 1, Withdrawn, Last updated: 19/05/2015
-
List item
Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group (updated)
valsartan, candesartan, irbesartan, losartan and 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: 02/03/2021 -
List item
Referral: Didanosine
didanosine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/09/2013, EC decision date: 20/11/2013, Last updated: 10/12/2013was Didanosine reviewed? Aurobindo Pharma (Malta) Limited submitted … was Didanosine reviewed? Aurobindo Pharma (Malta) Limited submitted … administration France Aurobindo Pharma (Malta) Limited … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013
CHMP, Last updated: 20/09/2013Marketing-authorisation holder Aurobindo Pharma (Malta) Limited More … -
List item
Referral: Ranitidine-containing medicinal products (updated)
ranitidine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 17/09/2020, EC decision date: 24/11/2020, Last updated: 17/02/2021 -
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: Retinoid-containing medicinal products
acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tretinoin, tazarotene, associated names: Targretin, Panretin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/03/2018, EC decision date: 21/06/2018, Last updated: 02/07/2018 -
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