Incivo
Expired
This medicine's authorisation has expired
telaprevir
MedicineHumanExpired
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Incivo has expired following the marketing-authorisation holder's decision not to apply for a renewal.
Incivo : EPAR - Summary for the public
Reference Number: EMA/644234/2011
English (EN) (541.29 KB - PDF)
First published: Last updated:
български (BG) (621.69 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
español (ES) (540.52 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
čeština (CS) (627.61 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
dansk (DA) (536.89 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Deutsch (DE) (540.78 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
eesti keel (ET) (602.19 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
ελληνικά (EL) (627.98 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
français (FR) (541.46 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
italiano (IT) (560.95 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
latviešu valoda (LV) (611.89 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
lietuvių kalba (LT) (566.07 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
magyar (HU) (599.87 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Malti (MT) (608.98 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Nederlands (NL) (537.39 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
polski (PL) (602.68 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
português (PT) (560.63 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
română (RO) (564.25 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
slovenčina (SK) (607.92 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
slovenščina (SL) (614.7 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Suomi (FI) (537.71 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
svenska (SV) (537.58 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Product information
Incivo : EPAR - Product Information
English (EN) (1.13 MB - PDF)
First published: Last updated:
български (BG) (4.44 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
español (ES) (1.19 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
čeština (CS) (1.97 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
dansk (DA) (864.34 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Deutsch (DE) (1.18 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
eesti keel (ET) (1.13 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
ελληνικά (EL) (2.56 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
français (FR) (1.2 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
hrvatski (HR) (1.14 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
íslenska (IS) (1.15 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
italiano (IT) (1.19 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
latviešu valoda (LV) (1.97 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
lietuvių kalba (LT) (1.16 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
magyar (HU) (2.01 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Malti (MT) (2.09 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Nederlands (NL) (1.14 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
norsk (NO) (1.1 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
polski (PL) (1.96 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
português (PT) (1.21 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
română (RO) (1.26 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
slovenčina (SK) (1.96 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
slovenščina (SL) (1.93 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Suomi (FI) (1.18 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
svenska (SV) (1.12 MB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Latest procedure affecting product information:
II/0035
25/06/2015
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).
Incivo : EPAR - All Authorised presentations
English (EN) (478.26 KB - PDF)
First published: Last updated:
български (BG) (495.63 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
español (ES) (478.33 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
čeština (CS) (491.12 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
dansk (DA) (479.45 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Deutsch (DE) (478.75 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
eesti keel (ET) (478.95 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
ελληνικά (EL) (498.05 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
français (FR) (478.19 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
hrvatski (HR) (485.46 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
íslenska (IS) (479.08 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
italiano (IT) (478.3 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
latviešu valoda (LV) (492.23 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
lietuvių kalba (LT) (479.1 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
magyar (HU) (491.38 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Malti (MT) (492.85 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Nederlands (NL) (478.88 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
norsk (NO) (478.46 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
polski (PL) (491.76 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
português (PT) (478.47 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
română (RO) (478.67 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
slovenčina (SK) (491.69 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
slovenščina (SL) (490.25 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Suomi (FI) (477.83 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
svenska (SV) (477.95 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Incivo : EPAR - Conditions imposed on member states for safe and effective use
English (EN) (507.83 KB - PDF)
First published: Last updated:
български (BG) (540.37 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
español (ES) (508.05 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
čeština (CS) (533.31 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
dansk (DA) (504.21 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Deutsch (DE) (511.02 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
eesti keel (ET) (503.08 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
ελληνικά (EL) (539.12 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
français (FR) (505.46 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
íslenska (IS) (504.35 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
italiano (IT) (504.42 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
latviešu valoda (LV) (529.11 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
lietuvių kalba (LT) (505.29 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
magyar (HU) (528.35 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Malti (MT) (58.61 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Nederlands (NL) (50.97 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
norsk (NO) (51.54 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
polski (PL) (51.64 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
português (PT) (51.43 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
română (RO) (51.64 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
slovenčina (SK) (53.51 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
slovenščina (SL) (46.63 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Suomi (FI) (502.13 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
svenska (SV) (51.4 KB - PDF)
First published: 03/10/2011Last updated: 06/10/2016
Product details
- Name of medicine
- Incivo
- Active substance
- telaprevir
- International non-proprietary name (INN) or common name
- telaprevir
- Therapeutic area (MeSH)
- Hepatitis C, Chronic
- Anatomical therapeutic chemical (ATC) code
- J05AE
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis):
- who are treatment naïve;
- who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.
Authorisation details
- EMA product number
- EMEA/H/C/002313
- Marketing authorisation holder
- Janssen-Cilag International N.V.
Turnhoutseweg 30
BE-2340 Beerse
Belgium - Marketing authorisation issued
- 19/09/2011
- Expiry of marketing authorisation
- 22/09/2016
- Revision
- 19
Assessment history
Incivo : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (693.19 KB - PDF)
First published: Last updated:
Incivo-H-C-2313-P46-023 : EPAR - Assessment Report
AdoptedReference Number: EMA/807529/2015
English (EN) (990.67 KB - PDF)
First published: Last updated:
Incivo-H-C-2313-PSUV-0028 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/CHMP/648366/2014
English (EN) (520.48 KB - PDF)
First published: Last updated:
Incivo-H-C-2313-PSUV-0024 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/CHMP/329265/2014
English (EN) (520.78 KB - PDF)
First published: Last updated:
Incivo-H-C-2313-PSUV-0021 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/CHMP/14619/2014
English (EN) (531.61 KB - PDF)
First published: Last updated:
More information on Incivo
Public statement on Incivo: Expiry of the marketing authorisation in the European Union
Reference Number: EMA/599647/2016
English (EN) (52.08 KB - PDF)
First published: Last updated:
More information on Incivo
This page was last updated on