Daklinza

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daclatasvir

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Daklinza has expired following the marketing-authorisation holder’s decision not to pursue the renewal of the marketing authorisation.

This EPAR was last updated on 30/08/2019

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 assessmentAccelerated 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 monitoringAdditional 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

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Product information

24/07/2019 Daklinza - EMEA/H/C/003768 - IA/0034

Contents

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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.

Assessment history

Changes since initial authorisation of medicine

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