119 results
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Opinion/decision on a Paediatric investigation plan (PIP): Harvoni, Sofosbuvir, ledipasvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001411-PIP01-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form, Age-appropriate dosage form, other
Decision date: 16/03/2017, Last updated: 21/09/2021, Compliance check: V, 26/04/2019Invented name Harvoni Active substance Sofosbuvir … sofosbuvir / ledipasvir (Harvoni), (EMEA-001411-PIP01-12-M04 … sofosbuvir / ledipasvir (Harvoni), (EMEA-001411-PIP01-12-M04 … -
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Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,
, Revision: 26, Authorised, Last updated: 10/11/2022
Harvoni Infections Communicable … Harvoni … initial authorisation) Harvoni Ledipasvir / sofosbuvir … -
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Referral: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)
daclatasvir, dasabuvir, sofosbuvir, ledipasvir, simeprevir, ombitasvir, paritaprevir, ritonavir, associated names: Sovaldi, Olysio, Viekirax, Harvoni, Exviera, Daklinza, Article 20 procedures
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 23/02/2017, Last updated: 09/03/2017EU as Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax)1 … including Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax … daclatasvir), Exviera (dasabuvir), Harvoni (sofosbuvir / ledipasvir … -
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Press release: Harvoni recommended for the treatment of chronic hepatitis C
CHMP, Last updated: 26/09/2014Harvoni recommended for the treatment … recommended the authorisation of Harvoni (ledipasvir / sofosbuvir … transplantation in the EU. Harvoni belongs to a new generation … -
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Press release: EMA recommends avoidance of certain hepatitis C medicines and amiodarone together
CHMP, Last updated: 24/04/2015the hepatitis C medicines Harvoni (sofosbuvir with ledipasvir … the hepatitis C medicines Harvoni (sofosbuvir with ledipasvir … patients taking the medicines Harvoni or Sovaldi plus Daklinza … -
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Press release: Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B
CHMP, Last updated: 16/12/2016EU as Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax)1 … EU as Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax)1 … including Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax … -
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Press release: PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C
PRAC, Last updated: 02/12/2016EU as Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax … EU as Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax)1 … daclatasvir), Exviera (dasabuvir), Harvoni (sofosbuvir / ledipasvir … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014
CHMP, Last updated: 26/09/2014Harvoni … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020
CHMP, Last updated: 30/04/2020Harvoni … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015
CHMP, Last updated: 24/04/2015Harvoni … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2017
CHMP, Last updated: 23/06/2017Harvoni … -
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Press release: Two new combination therapies against chronic hepatitis C
CHMP, Last updated: 27/05/2016ledipasvir under the name Harvoni, and velpatasvir which is … ledipasvir under the name Harvoni, and velpatasvir which is … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2016
PRAC, Last updated: 15/04/2016antivirals (Daklinza, Exviera, Harvoni, Olysio, Sovaldi, Viekirax … -
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Press release: Record number of medicines for rare diseases recommended for approval in 2014
Last updated: 09/01/2015assessment in 2014 (Daklinza, Harvoni, Exviera, Viekirax, Ofev … assessment in 2014 (Daklinza, Harvoni, Exviera, Viekirax, Ofev … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 March 2016
PRAC, Last updated: 18/03/2016antivirals (Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax … -
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Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, Revision: 18, Authorised, Last updated: 06/07/2022
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Human medicine European public assessment report (EPAR): Vosevi
Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic
Date of authorisation: 26/07/2017, Revision: 13, Authorised, Last updated: 01/08/2022 -
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Human medicine European public assessment report (EPAR): Viread (updated)
tenofovir disoproxil fumarate, Hepatitis B, Chronic; HIV Infections
Date of authorisation: 04/02/2002, Revision: 58, Authorised, Last updated: 04/01/2023 -
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Human medicine European public assessment report (EPAR): Olysio
simeprevir, Hepatitis C, Chronic
Date of authorisation: 14/05/2014,
, Revision: 13, Withdrawn, Last updated: 23/05/2018
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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: 45, Authorised, Last updated: 31/05/2021 -
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National expert: Alessandro Aiuti, European Medicines Agency (updated)
- Declaration of interests - 85.9 KB | PDF
- Curriculum Vitae - 97.2 KB | PDF
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Compassionate use
Last updated: 26/10/2020closure - Related content Harvoni …
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 18/01/2023 -
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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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PRAC recommendations on safety signals (updated)
Last updated: 05/01/2023