Daklinza
daclatasvir
Table of contents
Overview
The marketing authorisation for Daklinza has expired following the marketing-authorisation holder’s decision not to pursue the renewal of the marketing authorisation.
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List item
Daklinza : EPAR - Summary for the public (PDF/545.44 KB)
First published: 15/09/2014
EMA/525602/2014 -
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List item
Daklinza : EPAR - Risk-management-plan summary (PDF/751.3 KB)
First published: 15/09/2014
Last updated: 28/05/2019
Authorisation details
| Product details | |
|---|---|
| Name |
Daklinza
|
| Agency product number |
EMEA/H/C/003768
|
| Active substance |
daclatasvir dihydrochloride
|
| International non-proprietary name (INN) or common name |
daclatasvir
|
| Therapeutic area (MeSH) |
Hepatitis C, Chronic
|
| Anatomical therapeutic chemical (ATC) code |
J05AP07
|
Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Bristol-Myers Squibb Pharma EEIG
|
| Revision |
15
|
| Date of issue of marketing authorisation valid throughout the European Union |
22/08/2014
|
| Contact address |
Plaza 254 |
Product information
24/07/2019 Daklinza - EMEA/H/C/003768 - IA/0034
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antivirals for systemic use
Therapeutic indication
Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
For HCV genotype specific activity, see sections 4.4 and 5.1.