57 results
Keyword Bicalutamide AHCL Remove keyword
-
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
Human medicine European public assessment report (EPAR): Posaconazole AHCL
posaconazole, Mycoses
Date of authorisation: 25/07/2019,
, Authorised, Last updated: 28/08/2019
Posaconazole AHCL Mycoses … Posaconazole AHCL … Posaconazole AHCL posaconazole posaconazole … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-29 May 2019
CHMP, Last updated: 29/05/2019Posaconazole AHCL … -
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): 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): 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: Arimidex
anastrozole, Article 29 paediatrics
Status: European Commission final decision, EC decision date: 06/11/2009, Last updated: 28/05/2010 -
List item
Referral: GVK Biosciences
Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015 -
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: Arimidex
anastrozole, Article 30 referrals
Status: European Commission final decision, opinion/position date: 17/03/2011, EC decision date: 18/05/2011, Last updated: 27/07/2011 -
List item
Referral: Bisphosphonates
alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid, zoledronic acid, associated names: Actonel, Aredia, Bonefos, Didronel, Fosamax, Nerixia, Skelid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/04/2011, EC decision date: 13/07/2011, Last updated: 28/10/2011 -
List item
Referral: Sandimmun and associated names
ciclosporin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 27/06/2013, EC decision date: 31/10/2013, Last updated: 20/12/2013 -
List item
Referral: Sandimmun Neoral and associated names
ciclosporin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 27/06/2013, EC decision date: 31/10/2013, Last updated: 20/12/2013 -
List item
Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014 -
List item
Public data from Article 57 database (updated)
Last updated: 16/02/2021