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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: 20/04/2017, Compliance check: XKey facts Harvoni Sofosbuvir ledipasvir Infectious … sofosbuvir / ledipasvir (Harvoni), (EMEA-001411-PIP01-12-M04 … 20/04/2017 EMA/114829/2017 Generic Harvoni: EPAR Direct-acting antivirals … -
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Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,
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, Revision: 21, Authorised, Last updated: 29/07/2020
Harvoni Hepatitis C, Chronic … ledispavirsofosbuvir Overview Harvoni is an antiviral medicine … by the hepatitis C virus. Harvoni contains the active substances … -
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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) 19-22 June 2017
CHMP, Last updated: 23/06/2017Harvoni … -
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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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National expert: Hans Van Vlierberghe, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 84.39 KB | PDF
- Curriculum Vitae - 68.41 KB | PDF
01/2016-(current) Gilead HCV compounds (Harvoni, Sovaldi...) Hepatitis … -
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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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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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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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Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, , Revision: 14, Authorised, Last updated: 31/03/2021
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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: 44, Authorised, Last updated: 31/03/2021 -
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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: 9, Authorised, Last updated: 08/06/2020
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Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, , Revision: 19, Authorised, Last updated: 06/04/2021
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Human medicine European public assessment report (EPAR): Viekirax
Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, , Revision: 22, Authorised, Last updated: 12/03/2021
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Human medicine European public assessment report (EPAR): Viread
tenofovir disoproxil fumarate, Hepatitis B, Chronic, HIV Infections
Date of authorisation: 04/02/2002, Revision: 55, Authorised, Last updated: 25/01/2021 -
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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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National expert: Alessandro Aiuti, European Medicines Agency (updated)
- Declaration of interests - 84.54 KB | PDF
- Curriculum Vitae - 80.43 KB | PDF
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Compassionate use
Last updated: 26/10/2020closure - Related content Harvoni …