42 results
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Opinion/decision on a Paediatric investigation plan (PIP): Sebivo, telbivudine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000065-PIP01-07-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral solution
Decision date: 07/06/2017, Last updated: 25/07/2017, Compliance check: XInvented name Sebivo Active substance telbivudine … investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M05 … investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M05 … -
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Human medicine European public assessment report (EPAR): Sebivo
telbivudine, Hepatitis B, Chronic
Date of authorisation: 24/04/2007, Revision: 20, Withdrawn, Last updated: 14/01/2021Sebivo Hepatitis B, Chronic … Sebivo … EMEA/H/C/000713 Public statement Sebivo Withdrawal of the marketing … -
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News: Public statement: Risk of peripheral neuropathy with Sebivo (telbivudine)
CHMP, Last updated: 14/02/2008peripheral neuropathy with Sebivo (telbivudine … peripheral neuropathy with Sebivo (telbivudine … -
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Human medicine European public assessment report (EPAR): ViraferonPeg
peginterferon alfa-2b, Hepatitis C, Chronic
Date of authorisation: 28/05/2000, Revision: 36, Withdrawn, Last updated: 22/01/2021 -
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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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PRAC: Agendas, minutes and highlights (updated)
Last updated: 16/02/2021 -
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Download medicine data
Last updated: 29/04/2020 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 April 2017
European Medicines Agency, London, UK, from 03/04/2017 to 06/04/2017, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 April 2013
European Medicines Agency, London, UK, from 08/04/2013 to 11/04/2013, Last updated: 02/06/2012 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 May 2014
European Medicines Agency, London, UK, from 05/05/2014 to 08/05/2014, Last updated: 13/08/2013 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 March 2018
European Medicines Agency, London, UK, from 05/03/2018 to 08/03/2018, Last updated: 05/03/2018 -
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Paediatric Committee (PDCO): 10-12 April 2013
European Medicines Agency, London, UK, from 10/04/2013 to 12/04/2013, Last updated: 21/12/2010 -
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Paediatric Committee (PDCO): 23-25 April 2014
European Medicines Agency, London, UK, from 23/04/2014 to 25/04/2014, Last updated: 10/12/2010 -
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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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Pharmacovigilance Risk Assessment Committee (PRAC): 27-30 November 2017
European Medicines Agency, London, UK, from 27/11/2017 to 30/11/2017, Last updated: 27/11/2017 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 March 2014
European Medicines Agency, London, UK, from 03/03/2014 to 06/03/2014, Last updated: 13/08/2013 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 October 2013
European Medicines Agency, London, UK, from 07/10/2013 to 10/10/2013, Last updated: 02/07/2012 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 September 2016
European Medicines Agency, London, UK, from 26/09/2016 to 29/09/2016, Last updated: 13/03/2014 -
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Paediatric Committee (PDCO): 12-14 June 2013
European Medicines Agency, London, UK, from 12/06/2013 to 14/06/2013, Last updated: 21/12/2010 -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,19-22 February 2007
CHMP, Last updated: 23/02/2007time of 201 days. Sebivo (telbivudine), from Novartis … -
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Committee for Medicinal Products for Human Use (CHMP): 18-21 October 2010
European Medicines Agency, London, UK, from 18/10/2010 to 21/10/2010, Last updated: 16/02/2010amendments to the SmPC of Sebivo (telbivudine) from Novartis … -
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Paediatric Committee (PDCO): 15-17 May 2013
European Medicines Agency, London, UK, from 15/05/2013 to 17/05/2013, Last updated: 21/12/2010 -
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News: EMA 2017 annual report published
Last updated: 02/05/2018 -
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PRAC: meeting archive 2012-2013
Last updated: 13/05/2016 -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 March 2018
European Medicines Agency, London, UK, from 19/03/2018 to 22/03/2018, Last updated: 31/05/2018