59 results
Keyword Juluca Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Juluca, rilpivirine, dolutegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001750-PIP01-15-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 03/12/2021, Last updated: 22/03/2023, Compliance check: XInvented name Juluca Active substance rilpivirine … rilpivirine / dolutegravir (Juluca), (EMEA-001750-PIP01-15-M05 … rilpivirine / dolutegravir (Juluca), (EMEA-001750-PIP01-15-M05 … -
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Human medicine European public assessment report (EPAR): Juluca
dolutegravir sodium, rilpivirine hydrochloride, HIV Infections
Date of authorisation: 16/05/2018, Revision: 14, Authorised, Last updated: 02/02/2023Juluca Blood-Borne Infections Communicable … Juluca … THE MEDICINAL PRODUCT Juluca 50 mg/25 mg film-coated tablets … -
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Press release: New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir
PRAC, Last updated: 18/05/2018website. Another medicine, Juluca, a combination of dolutegravir … found here. Another medicine, Juluca, a combination of dolutegravir … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018
CHMP, Last updated: 23/03/2018Juluca … -
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Human medicine European public assessment report (EPAR): Triumeq
dolutegravir sodium, lamivudine, abacavir (as sulfate), HIV Infections
Date of authorisation: 31/08/2014, Revision: 31, Authorised, Last updated: 20/04/2023 -
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Human medicine European public assessment report (EPAR): Dovato
dolutegravir sodium, lamivudine, HIV Infections
Date of authorisation: 10/06/2022, Revision: 12, Authorised, Last updated: 08/11/2022 -
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Human medicine European public assessment report (EPAR): Tivicay
dolutegravir, HIV Infections
Date of authorisation: 16/01/2014, Revision: 33, Authorised, Last updated: 07/03/2023 -
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Human medicine European public assessment report (EPAR): Rekambys
rilpivirine, HIV Infections
Date of authorisation: 17/12/2020,
, Revision: 7, Authorised, Last updated: 23/11/2022
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Human medicine European public assessment report (EPAR): Vocabria
Cabotegavir sodium, Cabotegravir, HIV Infections
Date of authorisation: 17/12/2020,, Revision: 8, Authorised, Last updated: 12/01/2023
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 31/05/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 24-26 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 24/04/2023 to 26/04/2023, Last updated: 24/04/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 November - 1 December 2022
European Medicines Agency, Amsterdam, the Netherlands, from 28/11/2022 to 01/12/2022, Last updated: 03/04/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 24-27 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 24/10/2022 to 27/10/2022, Last updated: 31/03/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/05/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 16-19 August 2022
Written procedure, from 16/08/2022 to 19/08/2022, Last updated: 04/10/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 10-13 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/10/2022 to 13/10/2022, Last updated: 23/11/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 August - 1 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 29/08/2022 to 01/09/2022, Last updated: 02/09/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/03/2022 to 10/03/2022, Last updated: 22/11/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 February 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/02/2022 to 10/02/2022, Last updated: 07/11/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 June 2022
European Medicines Agency, Amsterdam, the Netherlands, from 20/06/2022 to 23/06/2022, Last updated: 18/08/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 November-2 December 2021
European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2021 to 02/12/2021, Last updated: 04/10/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 16-19 May 2022
European Medicines Agency, Amsterdam, the Netherlands, from 16/05/2022 to 19/05/2022, Last updated: 12/08/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2022 to 24/03/2022, Last updated: 12/08/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2022 to 10/06/2022, Last updated: 31/03/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 24-27 January 2022
European Medicines Agency, Amsterdam, the Netherlands, from 24/01/2022 to 27/01/2022, Last updated: 16/03/2022