Olysio
Withdrawn
This medicine's authorisation has been withdrawn
simeprevir
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 1 May 2018, the European Commission withdrew the marketing authorisation for Olysio (simeprevir) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Janssen-Cilag International NV, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Olysio was granted marketing authorisation in the EU on 14 May 2014 for the treatment of chronic hepatitis C (CHC) in adult patients, in combination with other medicinal products. The marketing authorisation was initially valid for a 5-year period.
The European Public Assessment Report (EPAR) for Olysio is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Olysio : EPAR - Summary for the public
English (EN) (548.55 KB - PDF)
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български (BG) (631.17 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
español (ES) (545.76 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
čeština (CS) (612.79 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
dansk (DA) (544.06 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Deutsch (DE) (549.52 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
eesti keel (ET) (542.55 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
ελληνικά (EL) (636.55 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
français (FR) (547.32 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
hrvatski (HR) (566.73 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
italiano (IT) (545.35 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
latviešu valoda (LV) (612.55 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
lietuvių kalba (LT) (573.19 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
magyar (HU) (607.91 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Malti (MT) (615.5 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Nederlands (NL) (545.49 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
polski (PL) (612.66 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
português (PT) (545.33 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
română (RO) (572.83 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
slovenčina (SK) (612.97 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
slovenščina (SL) (604.67 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Suomi (FI) (543.74 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
svenska (SV) (544.08 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Olysio : EPAR - Risk-management-plan summary
English (EN) (555.54 KB - PDF)
First published: Last updated:
Product information
Olysio : EPAR - Product Information
English (EN) (1.15 MB - PDF)
First published: Last updated:
български (BG) (2.23 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
español (ES) (1.18 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
čeština (CS) (1.84 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
dansk (DA) (1.19 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Deutsch (DE) (1.22 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
eesti keel (ET) (1.12 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
ελληνικά (EL) (2.33 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
français (FR) (1.14 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
hrvatski (HR) (1.22 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
íslenska (IS) (1.17 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
italiano (IT) (1.12 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
latviešu valoda (LV) (1.78 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
lietuvių kalba (LT) (1.19 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
magyar (HU) (1.85 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Malti (MT) (1.97 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Nederlands (NL) (1.21 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
norsk (NO) (1.2 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
polski (PL) (1.9 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
português (PT) (1.2 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
română (RO) (1.23 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
slovenčina (SK) (1.87 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
slovenščina (SL) (1.86 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Suomi (FI) (1.09 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
svenska (SV) (1.16 MB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Latest procedure affecting product information:
PSUSA/00010255/201705
08/02/2018
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).
Olysio : EPAR - All Authorised presentations
English (EN) (473.45 KB - PDF)
First published: Last updated:
български (BG) (494.22 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
español (ES) (472.79 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
čeština (CS) (486.06 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
dansk (DA) (473.7 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Deutsch (DE) (473.71 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
eesti keel (ET) (473.48 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
ελληνικά (EL) (493.72 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
français (FR) (473.61 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
hrvatski (HR) (473.63 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
íslenska (IS) (472.72 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
italiano (IT) (474.2 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
latviešu valoda (LV) (487.42 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
lietuvių kalba (LT) (474.24 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
magyar (HU) (487.25 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Malti (MT) (486.95 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Nederlands (NL) (472.89 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
norsk (NO) (472.92 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
polski (PL) (486.5 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
português (PT) (473.15 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
română (RO) (472.56 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
slovenčina (SK) (486.79 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
slovenščina (SL) (485.7 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Suomi (FI) (472.83 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
svenska (SV) (472.91 KB - PDF)
First published: 04/06/2014Last updated: 23/05/2018
Product details
- Name of medicine
- Olysio
- Active substance
- simeprevir
- International non-proprietary name (INN) or common name
- simeprevir
- Therapeutic area (MeSH)
- Hepatitis C, Chronic
- Anatomical therapeutic chemical (ATC) code
- J05AE14
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Olysio is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.
For hepatitis C virus (HCV) genotype specific activity.
Authorisation details
- EMA product number
- EMEA/H/C/002777
- Marketing authorisation holder
- Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium - Opinion adopted
- 20/03/2014
- Marketing authorisation issued
- 14/05/2014
- Withdrawal of marketing authorisation
- 01/05/2018
- Revision
- 13
Assessment history
Olysio : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (654.3 KB - PDF)
First published: Last updated:
Olysio-H-C-1438-A20-2777-0019 : EPAR - Assessment Report - Article 20
AdoptedReference Number: EMA/103226/2017
English (EN) (954.77 KB - PDF)
First published: Last updated:
Olysio : EPAR - Scientific Conclusion
English (EN) (538.81 KB - PDF)
First published: Last updated:
български (BG) (687.46 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
español (ES) (530.79 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
čeština (CS) (87.91 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
dansk (DA) (532.07 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
Deutsch (DE) (542.71 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
eesti keel (ET) (528.43 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
ελληνικά (EL) (698.83 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
français (FR) (530.89 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
hrvatski (HR) (572.64 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
italiano (IT) (538.07 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
latviešu valoda (LV) (664.34 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
lietuvių kalba (LT) (575.28 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
magyar (HU) (616.82 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
Malti (MT) (649.44 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
Nederlands (NL) (537.08 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
polski (PL) (648.48 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
português (PT) (538.2 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
română (RO) (576.84 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
slovenčina (SK) (631.52 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
slovenščina (SL) (650.63 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
Suomi (FI) (528.94 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
svenska (SV) (536.57 KB - PDF)
First published: 13/03/2017Last updated: 23/05/2018
Olysio-EMEA-H-C-PSUSA-00010255-201411 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/484307/2015
English (EN) (527.82 KB - PDF)
First published: Last updated:
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