56 results
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Opinion/decision on a Paediatric investigation plan (PIP): Baraclude, Entecavir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000339-PIP02-09-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral solution
Decision date: 16/05/2014, Last updated: 25/06/2014, Compliance check: V, 20/06/2014Invented name Baraclude Active substance Entecavir … entecavir (monohydrate) (Baraclude), (EMEA-000339-PIP02-09-M03 … entecavir (monohydrate) (Baraclude), (EMEA-000339-PIP02-09-M03 … -
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Human medicine European public assessment report (EPAR): Baraclude
Entecavir, Hepatitis B, Chronic
Date of authorisation: 26/06/2006, Revision: 26, Authorised, Last updated: 28/05/2020Baraclude Hepatitis B, Chronic … Baraclude … Baraclude EPAR summary II 41 update … -
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Press release: Public statement: Baraclude (entecavir): Occurrence of a resistant HIV variant in a patient co-infected with HIV and HBV
CHMP, Last updated: 05/03/2007Public statement: Baraclude (entecavir): Occurrence of … Public statement: Baraclude (entecavir): Occurrence of … PUBLIC STATEMENT BARACLUDE (entecavir) Occurrence of … -
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Human medicine European public assessment report (EPAR): Entecavir Accord
Entecavir, Hepatitis B, Chronic
Date of authorisation: 25/09/2017,
, Revision: 3, Authorised, Last updated: 29/01/2021
European Union (EU) called Baraclude. How is Entecavir Accord used … with the reference medicine, Baraclude, and do not need to be repeated … and to be bioequivalent to Baraclude. Therefore, the Agency’s … -
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Human medicine European public assessment report (EPAR): Entecavir Mylan (updated)
entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017,, Revision: 3, Authorised, Last updated: 25/02/2021
European Union (EU) called Baraclude. How is Entecavir Mylan used … with the reference medicine, Baraclude, and do not need to be repeated … and to be bioequivalent to Baraclude. Therefore, the Agency’s … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2014
CHMP, Last updated: 25/07/2014Baraclude … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 January 2011
CHMP, Last updated: 21/01/2011Baraclude … Union (EU), for: • Baraclude (entecavir), from Bristol-Myers … -
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Human medicine European public assessment report (EPAR): Viread
tenofovir disoproxil fumarate, Hepatitis B, Chronic, HIV Infections
Date of authorisation: 04/02/2002, Revision: 55, Authorised, Last updated: 25/01/2021 -
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Human medicine European public assessment report (EPAR): Hepsera
adefovir dipivoxil, Hepatitis B, Chronic
Date of authorisation: 06/03/2003, Revision: 26, Authorised, Last updated: 08/08/2019 -
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Human Medicines Highlights: Issue 24 - January 2011
Last updated: 01/02/2011Baraclude ( entecavir ) – new indication …
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Herbal medicinal product: Mate folium
Ilex paraguariensis St. Hilaire, Maté Leaf, F: Assessment finalised, Last updated: 01/03/2018 -
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Orphan designation: dexamethasone for: Treatment of multiple myeloma
Date of first decision: 09/06/2010, Withdrawn, Last updated: 12/02/2018kezelése Italian Desametasone (compressa da 40 mg) Trattamento del … -
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Orphan designation: hydrocortisone for: Treatment of adrenal insufficiency
Date of first decision: 22/05/2006, Positive, Last updated: 01/07/2016 -
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia
Date of first decision: 27/07/2005, Positive, Last updated: 23/03/2015 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 16/02/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 17-20 September 2018
European Medicines Agency, London, UK, from 17/09/2018 to 20/09/2018, Last updated: 31/10/2018 -
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Deadlines for placing paediatric medicines on the market
Last updated: 10/08/2015 -
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Download medicine data
Last updated: 29/04/2020 -
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Sampling and testing
Last updated: 28/03/2019 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 March 2016
European Medicines Agency, London, UK, from 14/03/2016 to 17/03/2016, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 February 2014
European Medicines Agency, London, UK, from 03/02/2014 to 06/02/2014, Last updated: 13/08/2013 -
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Paediatric Committee (PDCO): 17-19 July 2013
European Medicines Agency, London, UK, from 17/07/2013 to 19/07/2013, Last updated: 21/12/2010 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 January 2018
European Medicines Agency, London, UK, from 08/01/2018 to 11/01/2018, Last updated: 13/03/2014 -
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Key documents
Last updated: 21/12/2020 -
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Committee for Medicinal Products for Human Use (CHMP): 23-26 April 2018
European Medicines Agency, London, UK, from 23/04/2018 to 26/04/2018, Last updated: 08/06/2018