- 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Assessment Report (EPAR) for Victrelis is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.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)
български (BG) (617.99 KB - PDF)
español (ES) (515.33 KB - PDF)
čeština (CS) (585.54 KB - PDF)
dansk (DA) (575.75 KB - PDF)
Deutsch (DE) (577.49 KB - PDF)
eesti keel (ET) (514.74 KB - PDF)
ελληνικά (EL) (686.2 KB - PDF)
français (FR) (576.69 KB - PDF)
italiano (IT) (516.73 KB - PDF)
latviešu valoda (LV) (589.22 KB - PDF)
lietuvių kalba (LT) (603.5 KB - PDF)
magyar (HU) (636.49 KB - PDF)
Malti (MT) (583.7 KB - PDF)
Nederlands (NL) (575.63 KB - PDF)
polski (PL) (584.22 KB - PDF)
português (PT) (574.86 KB - PDF)
română (RO) (545.35 KB - PDF)
slovenčina (SK) (640.78 KB - PDF)
slovenščina (SL) (634.62 KB - PDF)
Suomi (FI) (575.43 KB - PDF)
svenska (SV) (575.08 KB - PDF)
Product information
Victrelis: EPAR - Product Information
English (EN) (1.65 MB - PDF)
български (BG) (2.79 MB - PDF)
español (ES) (1.79 MB - PDF)
čeština (CS) (2.42 MB - PDF)
dansk (DA) (1.69 MB - PDF)
Deutsch (DE) (1.85 MB - PDF)
eesti keel (ET) (1.72 MB - PDF)
ελληνικά (EL) (3.09 MB - PDF)
français (FR) (1.83 MB - PDF)
hrvatski (HR) (1.73 MB - PDF)
íslenska (IS) (1.69 MB - PDF)
italiano (IT) (1.84 MB - PDF)
latviešu valoda (LV) (2.51 MB - PDF)
lietuvių kalba (LT) (1.72 MB - PDF)
magyar (HU) (2.52 MB - PDF)
Malti (MT) (2.71 MB - PDF)
Nederlands (NL) (1.83 MB - PDF)
norsk (NO) (1.69 MB - PDF)
polski (PL) (2.59 MB - PDF)
português (PT) (1.8 MB - PDF)
română (RO) (1.84 MB - PDF)
slovenčina (SK) (2.53 MB - PDF)
slovenščina (SL) (2.41 MB - PDF)
Suomi (FI) (1.76 MB - PDF)
svenska (SV) (1.72 MB - PDF)
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)
български (BG) (586.88 KB - PDF)
español (ES) (499.2 KB - PDF)
čeština (CS) (539.55 KB - PDF)
dansk (DA) (498.85 KB - PDF)
Deutsch (DE) (499.03 KB - PDF)
eesti keel (ET) (499.25 KB - PDF)
ελληνικά (EL) (582.85 KB - PDF)
français (FR) (499.3 KB - PDF)
hrvatski (HR) (477.03 KB - PDF)
íslenska (IS) (498.37 KB - PDF)
italiano (IT) (498.09 KB - PDF)
latviešu valoda (LV) (578.76 KB - PDF)
lietuvių kalba (LT) (528.05 KB - PDF)
magyar (HU) (541.13 KB - PDF)
Malti (MT) (538.89 KB - PDF)
Nederlands (NL) (498.89 KB - PDF)
norsk (NO) (45.75 KB - PDF)
polski (PL) (579.25 KB - PDF)
português (PT) (499.39 KB - PDF)
română (RO) (527.6 KB - PDF)
slovenčina (SK) (525.2 KB - PDF)
slovenščina (SL) (512.72 KB - PDF)
Suomi (FI) (497.57 KB - PDF)
svenska (SV) (497.78 KB - PDF)
Victrelis: EPAR - Conditions imposed on member states for safe and effective use
English (EN) (474.92 KB - PDF)
български (BG) (576.41 KB - PDF)
español (ES) (475.53 KB - PDF)
čeština (CS) (562.77 KB - PDF)
dansk (DA) (475.78 KB - PDF)
Deutsch (DE) (476.08 KB - PDF)
eesti keel (ET) (476.76 KB - PDF)
ελληνικά (EL) (605.68 KB - PDF)
français (FR) (473.37 KB - PDF)
íslenska (IS) (474.42 KB - PDF)
italiano (IT) (476.21 KB - PDF)
latviešu valoda (LV) (577.45 KB - PDF)
lietuvių kalba (LT) (538.63 KB - PDF)
magyar (HU) (559.92 KB - PDF)
Malti (MT) (570.51 KB - PDF)
Nederlands (NL) (474.38 KB - PDF)
norsk (NO) (477.78 KB - PDF)
polski (PL) (567.95 KB - PDF)
português (PT) (473.04 KB - PDF)
română (RO) (562.23 KB - PDF)
slovenčina (SK) (593.34 KB - PDF)
slovenščina (SL) (579.94 KB - PDF)
Suomi (FI) (475.72 KB - PDF)
svenska (SV) (475.74 KB - PDF)
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)
Victrelis-H-C-2332-PSUV-0031 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
English (EN) (517.34 KB - PDF)
Victrelis-H-C-2332-P46-0035 : EPAR - Assessment Report
English (EN) (597.86 KB - PDF)
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)
Victrelis-H-C-2332-PSUV-0024 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
English (EN) (520.52 KB - PDF)
Victrelis-H-C-2332-PSU-0020 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
English (EN) (524.83 KB - PDF)
Victrelis-H-C-2332-II-0005: EPAR - Assessment Report - Variation
English (EN) (944.87 KB - PDF)
News on Victrelis
More information on Victrelis
Questions and answers on drug interactions between Victrelis (boceprevir) and ritonavir-boosted HIV protease inhibitors
English (EN) (115.97 KB - PDF)
Victrelis: Product information as approved by the CHMP on 16 February 2012, pending endosement by the European Commission
English (EN) (428.63 KB - PDF)