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Keyword Viramune Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Viramune, nevirapine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000391-PIP01-08-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet, Tablet, Oral suspension
Decision date: 03/03/2010, Last updated: 19/04/2010, Compliance check: V, 06/08/2010Invented name Viramune Active substance nevirapine … Investigation Plan for nevirapine (Viramune) (EMEA-000391-PIP01-08-M01 … Investigation Plan for nevirapine (Viramune) (EMEA-000391-PIP01-08-M01 … -
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Human medicine European public assessment report (EPAR): Viramune
nevirapine, HIV Infections
Date of authorisation: 04/02/1998, Revision: 44, Authorised, Last updated: 21/04/2023Viramune Blood-Borne Infections Communicable … Viramune … summary for the public Viramune nevirapine This is a summary … -
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News: Public Statement on Viramune (Nevirapine) - Severe and Life-Threatening Cutaneous and Hepatic Reactions
Last updated: 12/04/2000Public Statement on Viramune (Nevirapine) - Severe and … sometimes fatal, associated with Viramune1 (nevirapine). This has led … Public Assessment Report of Viramune published on the EMEA Website … -
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Press release: Updated advice on body fat changes and lactic acidosis with HIV medicines
CHMP, Last updated: 23/10/2015Triumeq, Trizivir, Truvada, Viramune, Viread, Zerit and Ziagen … Triumeq, Trizivir, Truvada, Viramune, Viread, Zerit and Ziagen … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 2015
CHMP, Last updated: 23/10/2015Trizivir: EPAR Truvada: EPAR Viramune: EPAR Viread: EPAR Volibris … Paediatric investigation plan Viramune: Paediatric investigation … -
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Human medicine European public assessment report (EPAR): Nevirapine Teva
nevirapine, HIV Infections
Date of authorisation: 30/11/2009,
, Revision: 11, Withdrawn, Last updated: 21/03/2023
is a generic medicine of Viramune. The European Public Assessment … -
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Human medicine European public assessment report (EPAR): Sifrol
pramipexole dihydrochloride monohydrate, Restless Legs Syndrome; Parkinson Disease
Date of authorisation: 13/10/1997, Revision: 37, Authorised, Last updated: 25/07/2023 -
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Human medicine European public assessment report (EPAR): Mirapexin
pramipexole dihydrochloride monohydrate, Restless Legs Syndrome; Parkinson Disease
Date of authorisation: 23/02/1998, Revision: 40, Authorised, Last updated: 25/07/2023 -
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Human medicine European public assessment report (EPAR): MicardisPlus
Telmisartan, hydrochlorothiazide, Hypertension
Date of authorisation: 19/04/2002, Revision: 33, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): Stribild
elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 24/05/2013, Revision: 25, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Pradaxa (updated)
Dabigatran etexilate mesilate, Arthroplasty, Replacement; Venous Thromboembolism
Date of authorisation: 17/03/2008, Revision: 40, Authorised, Last updated: 24/11/2023 -
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Human medicine European public assessment report (EPAR): Truvada
emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 20/02/2005, Revision: 46, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Trajenta
linagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 23/08/2011, Revision: 19, Authorised, Last updated: 17/05/2023 -
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Human medicine European public assessment report (EPAR): Aptivus
tipranavir, HIV Infections
Date of authorisation: 25/10/2005, Revision: 42, Authorised, Last updated: 23/08/2022 -
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Human medicine European public assessment report (EPAR): Onduarp
Telmisartan, Hypertension
Date of authorisation: 24/11/2011, Revision: 2, Withdrawn, Last updated: 02/04/2014 -
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Human medicine European public assessment report (EPAR): Invega
paliperidone, Schizophrenia; Psychotic Disorders
Date of authorisation: 24/06/2007, Revision: 18, Authorised, Last updated: 19/05/2020 -
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Sampling and testing (updated)
Last updated: 07/11/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 January 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/01/2022 to 13/01/2022, Last updated: 07/10/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 17-20 May 2021
European Medicines Agency, Amsterdam, the Netherlands, from 17/05/2021 to 20/05/2021, Last updated: 07/12/2021 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 30/11/2023 -
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Press release: Committee for Proprietary Medicinal Products (CPMP) 35th plenary meeting
Last updated: 27/02/1998Tetanus and Hepatitis B, for VIRAMUNE (nevirapine) indicated for … 21.11.97 b) 05.02.98 c) d) a) Viramune b) nevirapine c) Part B a … -
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Committee for Medicinal Products for Human Use (CHMP): 19-22 October 2015
European Medicines Agency, London, UK, from 19/10/2015 to 22/10/2015, Last updated: 03/01/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 10-13 June 2014
European Medicines Agency, London, UK, from 10/06/2014 to 13/06/2014, Last updated: 13/08/2013 -
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Deadlines for placing paediatric medicines on the market
Last updated: 10/08/201511/05/2011 11/05/2013 Yes Viramune EMEA-000391-PIP01-08-M01 … Tablets and oral suspension Viramune is indicated in combination …
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 July 2014
European Medicines Agency, London, UK, from 07/07/2014 to 10/07/2014, Last updated: 13/08/2013