110 results
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Opinion/decision on a Paediatric investigation plan (PIP): Sebivo,
Decision type: PM: decision on the application for modification of an agreed PIP, PIP number: EMEA-000065-PIP01-07-M05, decision date: 07/06/2017, Last updated: 25/07/2017, compliance check: Xinvestigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M05 … investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M05 … investigation plan for telbivudine (Sebivo), film-coated tablet, oral … -
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Human medicine European public assessment report (EPAR): Sebivo
Date of authorisation: 24/04/2007, Revision: 20, Authorised, Last updated: 29/05/2018Sebivo EPAR Summary update R 23 … summary for the public Sebivo telbivudine This is a … assessment report (EPAR) for Sebivo. It explains how the Committee … -
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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): Hepsera
Date of authorisation: 06/03/2003, Revision: 26, Authorised, Last updated: 08/08/2019 -
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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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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): 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): 8-11 April 2013
European Medicines Agency, London, UK, from 08/04/2013 to 11/04/2013, Last updated: 02/06/2012