Victrelis
Withdrawn
This medicine's authorisation has been withdrawn
boceprevir
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Victrelis has been withdrawn at the request of the marketing-authorisation holder.
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
- 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
Public statement on Victrelis
Reference Number: EMA/375478/2018
English (EN) (59.22 KB - PDF)
First published: Last updated:
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