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. |
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
| 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 | |
Product information
24/07/2019 Daklinza - EMEA/H/C/003768 - IA/0034
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.