37 results
Keyword Dutasteride Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): dutasteride, tamsulosin hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Uro-nephrology
PIP number: EMEA-000216-PIP01-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule
Decision date: 24/06/2008, Last updated: 21/07/2008, Compliance check: XKey facts dutasteride tamsulosin hydrochloride … product specific waiver for dutasteride, tamsulosin hydrochloride … Word - Decision and Opinion dutasteride-tamsulosin hydrochloride … … -
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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: 14/12/2016standards. • The medicines Dutasteride Actavis dutasteride), Lutigest/Lutinus (progesterone … recommendations. • Other medicines (Dutasteride Actavis dutasteride), Lutigest/Lutinus (progesterone … phenylbutyrate progesterone dutasteride colecalciferol sodium phenylbutyrate Sodium … -
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Press release: Pharmaceutics International Inc., US: supply of non-critical medicines to EU to be stopped due to manufacturing failings
CHMP, Last updated: 16/09/2016standards. The medicines Dutasteride Actavis dutasteride), Lutigest/Lutinus (progesterone … standards. • The medicines Dutasteride Actavis dutasteride), Lutigest/Lutinus (progesterone … recommendations. • Other medicines (Dutasteride Actavis dutasteride), Lutigest/Lutinus (progesterone … -
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National expert: Martijn van Gils, Medicines Evaluation Board
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 19.56 KB | PDF
Preliminary evaluation of the effect of dutasteride on PCA3 in post-DRE urine … -
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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: 20, Authorised, Last updated: 10/05/2022 -
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Human medicine European public assessment report (EPAR): Tadalafil Mylan
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,
, Revision: 13, Authorised, Last updated: 28/09/2021
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Human medicine European public assessment report (EPAR): Ammonaps
Sodium phenylbutyrate, Ornithine Carbamoyltransferase Deficiency Disease; Citrullinemia; Carbamoyl-Phosphate Synthase I Deficiency Disease
Date of authorisation: 07/12/1999, Revision: 20, Authorised, Last updated: 11/11/2020 -
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Human medicine European public assessment report (EPAR): Urorec
silodosin, Prostatic Hyperplasia
Date of authorisation: 29/01/2010, Revision: 18, Authorised, Last updated: 06/04/2022 -
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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: 30/03/2022 -
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Human medicine European public assessment report (EPAR): Silodyx
silodosin, Prostatic Hyperplasia
Date of authorisation: 29/01/2010, Revision: 15, Authorised, Last updated: 07/07/2021 -
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,
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, Revision: 25, Authorised, Last updated: 12/05/2022
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Human medicine European public assessment report (EPAR): Cialis
tadalafil, Erectile Dysfunction
Date of authorisation: 12/11/2002, Revision: 30, Authorised, Last updated: 11/10/2021 -
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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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National expert: Wilhelmus Petrus Johannes (Wim) Witjes, European Medicines Agency
- Declaration of interests - 82.15 KB | PDF
- Curriculum Vitae - 40.3 KB | PDF
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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 -
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Public data from Article 57 database
Last updated: 02/06/2021 -
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Periodic safety update reports (PSURs)
Last updated: 09/07/2021 -
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Press release: EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
Last updated: 24/03/2017 -
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Paediatric Committee (PDCO): 30 March – 1 April 2016
European Medicines Agency, London, UK, from 30/03/2016 to 01/04/2016, Last updated: 30/06/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 July 2018
European Medicines Agency, London, UK, from 09/07/2018 to 12/07/2018, Last updated: 13/03/2014 -
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PRAC recommendations on safety signals
Last updated: 07/02/2022 -
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PDCO: meeting archive 2015-2017
Last updated: 19/04/2022 -
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Periodic safety update reports
Last updated: 26/09/2018 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 02/05/2022 -
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Press release: Meeting highlights from the Paediatric Committee: 6 - 8 May 2008
PDCO, Last updated: 15/05/2008therapeutic area of nephrology; Dutasteride and tamsulosin hydrochloride …