Victrelis
Withdrawn
This medicine's authorisation has been withdrawn
boceprevir
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 29 June 2018, the European Commission withdrew the marketing authorisation for Victrelis (boceprevir) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Victrelis was granted marketing authorisation in the EU on 18 July 2011 for treatment of chronic hepatitis C. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2016.
The European Public Assessment Report (EPAR) for Victrelis is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Victrelis : EPAR - Summary for the public
English (EN) (513.73 KB - PDF)
First published: Last updated:
български (BG) (617.99 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
español (ES) (515.33 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
čeština (CS) (585.54 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
dansk (DA) (575.75 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Deutsch (DE) (577.49 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
eesti keel (ET) (514.74 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
ελληνικά (EL) (686.2 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
français (FR) (576.69 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
italiano (IT) (516.73 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
latviešu valoda (LV) (589.22 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
lietuvių kalba (LT) (603.5 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
magyar (HU) (636.49 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Malti (MT) (583.7 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Nederlands (NL) (575.63 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
polski (PL) (584.22 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
português (PT) (574.86 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
română (RO) (545.35 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
slovenčina (SK) (640.78 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
slovenščina (SL) (634.62 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Suomi (FI) (575.43 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
svenska (SV) (575.08 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Product information
Victrelis: EPAR - Product Information
English (EN) (1.65 MB - PDF)
First published: Last updated:
български (BG) (2.79 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
español (ES) (1.79 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
čeština (CS) (2.42 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
dansk (DA) (1.69 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Deutsch (DE) (1.85 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
eesti keel (ET) (1.72 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
ελληνικά (EL) (3.09 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
français (FR) (1.83 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
hrvatski (HR) (1.73 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
íslenska (IS) (1.69 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
italiano (IT) (1.84 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
latviešu valoda (LV) (2.51 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
lietuvių kalba (LT) (1.72 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
magyar (HU) (2.52 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Malti (MT) (2.71 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Nederlands (NL) (1.83 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
norsk (NO) (1.69 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
polski (PL) (2.59 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
português (PT) (1.8 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
română (RO) (1.84 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
slovenčina (SK) (2.53 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
slovenščina (SL) (2.41 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Suomi (FI) (1.76 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
svenska (SV) (1.72 MB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Latest procedure affecting product information:
II/0042
29/06/2017
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Victrelis : EPAR - All Authorised presentations
English (EN) (497.59 KB - PDF)
First published: Last updated:
български (BG) (586.88 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
español (ES) (499.2 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
čeština (CS) (539.55 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
dansk (DA) (498.85 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Deutsch (DE) (499.03 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
eesti keel (ET) (499.25 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
ελληνικά (EL) (582.85 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
français (FR) (499.3 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
hrvatski (HR) (477.03 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
íslenska (IS) (498.37 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
italiano (IT) (498.09 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
latviešu valoda (LV) (578.76 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
lietuvių kalba (LT) (528.05 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
magyar (HU) (541.13 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Malti (MT) (538.89 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Nederlands (NL) (498.89 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
norsk (NO) (45.75 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
polski (PL) (579.25 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
português (PT) (499.39 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
română (RO) (527.6 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
slovenčina (SK) (525.2 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
slovenščina (SL) (512.72 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Suomi (FI) (497.57 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
svenska (SV) (497.78 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Victrelis: EPAR - Conditions imposed on member states for safe and effective use
English (EN) (474.92 KB - PDF)
First published: Last updated:
български (BG) (576.41 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
español (ES) (475.53 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
čeština (CS) (562.77 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
dansk (DA) (475.78 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Deutsch (DE) (476.08 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
eesti keel (ET) (476.76 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
ελληνικά (EL) (605.68 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
français (FR) (473.37 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
íslenska (IS) (474.42 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
italiano (IT) (476.21 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
latviešu valoda (LV) (577.45 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
lietuvių kalba (LT) (538.63 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
magyar (HU) (559.92 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Malti (MT) (570.51 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Nederlands (NL) (474.38 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
norsk (NO) (477.78 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
polski (PL) (567.95 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
português (PT) (473.04 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
română (RO) (562.23 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
slovenčina (SK) (593.34 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
slovenščina (SL) (579.94 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Suomi (FI) (475.72 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
svenska (SV) (475.74 KB - PDF)
First published: 03/08/2011Last updated: 31/07/2018
Product details
- Name of medicine
- Victrelis
- Active substance
- Boceprevir
- International non-proprietary name (INN) or common name
- boceprevir
- Therapeutic area (MeSH)
- Hepatitis C, Chronic
- Anatomical therapeutic chemical (ATC) code
- J05AE
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Victrelis is indicated for the treatment of chronic hepatitis-C (CHC) genotype-1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
Authorisation details
- EMA product number
- EMEA/H/C/002332
- Marketing authorisation holder
- Merck Sharp Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom - Marketing authorisation issued
- 18/07/2011
- Withdrawal of marketing authorisation
- 29/06/2018
- Revision
- 22
Assessment history
Victrelis : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (792.04 KB - PDF)
First published: Last updated:
Victrelis-H-C-2332-PSUV-0031 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/CHMP/768663/2014
English (EN) (517.34 KB - PDF)
First published: Last updated:
Victrelis-H-C-2332-P46-0035 : EPAR - Assessment Report
AdoptedReference Number: EMA/594074/2014
English (EN) (597.86 KB - PDF)
First published: Last updated:
Victrelis-H-C-2332-PSUV-0028 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
English (EN) (522.27 KB - PDF)
First published: Last updated:
Victrelis-H-C-2332-PSUV-0024 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
AdoptedReference Number: EMA/CHMP/99097/2014
English (EN) (520.52 KB - PDF)
First published: Last updated:
Victrelis-H-C-2332-PSU-0020 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
AdoptedReference Number: EMA/CHMP/547111/2013
English (EN) (524.83 KB - PDF)
First published: Last updated:
Victrelis-H-C-2332-II-0005: EPAR - Assessment Report - Variation
Adopted
English (EN) (944.87 KB - PDF)
First published: Last updated:
News on Victrelis
More information on Victrelis
Questions and answers on drug interactions between Victrelis (boceprevir) and ritonavir-boosted HIV protease inhibitors
Reference Number: EMA/CHMP/117973/2012
English (EN) (115.97 KB - PDF)
First published: Last updated:
Victrelis: Product information as approved by the CHMP on 16 February 2012, pending endosement by the European Commission
English (EN) (428.63 KB - PDF)
First published: Last updated:
More information on Victrelis
This page was last updated on