59 results
Keyword Bicalutamide Remove keyword
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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 … medicines containing 150 mg bicalutamide, used orally (by mouth) for … all medicines containing bicalutamide 150 mg, both those that are … -
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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 … and associated names, INN-bicalutamide European Medicines … Non-Proprietary Name (INN): bicalutamide BACKGROUND INFORMATION … -
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Human medicine European public assessment report (EPAR): Firmagon
degarelix, Prostatic Neoplasms
Date of authorisation: 17/02/2009, Revision: 19, Authorised, Last updated: 04/10/2022medicines, goserelin and bicalutamide. After 12 weeks of treatment … those receiving goserelin and bicalutamide. What are the risks associated … medicines, goserelin and bicalutamide. After 12 weeks of treatment … -
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National expert: Kristian Wennmalm, Medical Products Agency (updated)
- Declaration of interests - 41 KB | PDF
- Curriculum Vitae - 29.36 KB | PDF
2011; academic (Docetaxel, Bicalutamide). 1.11 Committee for Advanced … -
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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 … -
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Human medicine European public assessment report (EPAR): Orgovyx
relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022,
, Revision: 7, Authorised, Last updated: 18/07/2023
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Human medicine European public assessment report (EPAR): Lojuxta
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,, 
, Revision: 17, Authorised, Last updated: 14/06/2023
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Human medicine European public assessment report (EPAR): Erleada (updated)
apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019,, Revision: 10, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Lynparza (updated)
Olaparib, Ovarian Neoplasms
Date of authorisation: 16/12/2014, Revision: 23, Authorised, Last updated: 21/09/2023 -
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Human medicine European public assessment report (EPAR): Xtandi
enzalutamide, Prostatic Neoplasms
Date of authorisation: 21/06/2013,
Date of refusal: 26/04/2013, Revision: 21, Authorised, Last updated: 17/06/2022 -
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Human medicine European public assessment report (EPAR): Xofigo
radium (223Ra) dichloride, Prostatic Neoplasms
Date of authorisation: 13/11/2013,, Revision: 13, Authorised, Last updated: 16/05/2023
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Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,
, Revision: 26, Authorised, Last updated: 06/12/2022
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Human medicine European public assessment report (EPAR): Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 20/04/2007, Revision: 30, Withdrawn, Last updated: 20/05/2022 -
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Human medicine European public assessment report (EPAR): Opdivo (updated)
nivolumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Mesothelioma; Colorectal Neoplasms
Date of authorisation: 19/06/2015, Revision: 55, Authorised, Last updated: 08/09/2023 -
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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
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Human medicine European public assessment report (EPAR): Yervoy
Ipilimumab, Melanoma; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Mesothelioma, Malignant; Colorectal Neoplasms
Date of authorisation: 13/07/2011, Revision: 52, Authorised, Last updated: 15/06/2023 -
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Human medicine European public assessment report (EPAR): Pylclari
Piflufolastat (18F), Prostatic Neoplasms
Date of authorisation: 24/07/2023,, Authorised, Last updated: 28/07/2023
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National expert: Antonio Portolés, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 44.8 KB | PDF
- Curriculum Vitae - 54.71 KB | PDF
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Referral: Arimidex
anastrozole, Article 29 paediatrics
Status: European Commission final decision, EC decision date: 06/11/2009, Last updated: 28/05/2010 -
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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 -
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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 -
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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 -
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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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Anastrozole
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: Anastrozole, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 06/02/2009, Last updated: 23/04/2009, Compliance check: V, 03/04/2009 -
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Public data from Article 57 database
Last updated: 30/06/2023