64 results
Keyword Bicalutamide AHCL 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): Posaconazole AHCL
posaconazole, Mycoses
Date of authorisation: 25/07/2019,
, Revision: 5, Authorised, Last updated: 22/12/2022
Posaconazole AHCL Infections Bacterial Infections … Posaconazole AHCL … PRODUCT Posaconazole AHCL 40 mg/mL oral suspension … -
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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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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-29 May 2019
CHMP, Last updated: 29/05/2019Posaconazole AHCL … -
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National expert: Kristian Wennmalm, Medical Products Agency (updated)
- Declaration of interests - 81.12 KB | PDF
- Curriculum Vitae - 19.76 KB | PDF
2011; academic (Docetaxel, Bicalutamide). 2.11 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): 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): 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): Orgovyx
relugolix, Prostatic Neoplasms
Date of authorisation: 29/04/2022,
, Revision: 4, Authorised, Last updated: 17/08/2022
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Human medicine European public assessment report (EPAR): Lojuxta
Lomitapide, Hypercholesterolemia
Date of authorisation: 31/07/2013,, 
, Revision: 15, Authorised, Last updated: 22/03/2022
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Human medicine European public assessment report (EPAR): Xofigo
radium (223Ra) dichloride, Prostatic Neoplasms
Date of authorisation: 13/11/2013,, Revision: 12, Authorised, Last updated: 07/07/2022
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Human medicine European public assessment report (EPAR): Erleada
apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019,, Revision: 8, Authorised, Last updated: 25/08/2022
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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): 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: 50, Authorised, Last updated: 07/12/2022 -
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Human medicine European public assessment report (EPAR): Opdivo
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: 51, Authorised, Last updated: 07/12/2022 -
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National expert: Antonio Portolés, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 82.88 KB | PDF
- Curriculum Vitae - 43.11 KB | PDF
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Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, 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 -
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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: 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: 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: 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 -
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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