Daklinza

daclatasvir

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This is a summary of the European public assessment report (EPAR) for Daklinza. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Daklinza.

For practical information about using Daklinza, patients should read the package leaflet or contact their doctor or pharmacist.

What is Daklinza and what is it used for?

Daklinza is an antiviral medicine used in combination with other medicines to treat chronic (long-term) hepatitis C (an infectious disease of the liver, caused by the hepatitis C virus) in adults.

It contains the active substance daclatasvir.

How is Daklinza used?

Daklinza can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.

Daklinza is available as 30, 60, and 90 mg tablets. The usual dose is 60 mg once a day. The dose may have to be raised or lowered if the patient is taking other medicines that decrease or increase Daklinza’s effects. Daklinza must be used in combination with other medicines for chronic hepatitis C, such as sofosbuvir, peginterferon alfa and ribavirin.

The combination of medicines to use and the duration of treatment will depend on the genotype (genetic make-up) of hepatitis C virus the patient is infected with and the nature of the patient’s liver problem, for example liver cirrhosis (scarring) or the liver not working well enough. For further information, see the package leaflet.

How does Daklinza work?

The active substance in Daklinza, daclatasvir, blocks the action of a protein in the hepatitis C virus called ‘NS5A’, which is essential for the virus to multiply. By blocking this protein, the medicine stops the hepatitis C virus from multiplying. There are several genotypes of the hepatitis C virus and Daklinza has been shown to be effective against genotypes 1 to 4.

What benefits of Daklinza have been shown in studies?

Daklinza used in combination with sofosbuvir (with or without ribavirin) was effective at clearing the hepatitis C virus from the blood in a main study involving 211 adults. The patients in the study were infected with genotypes 1, 2 or 3 and all received treatment for 12 or 24 weeks. Most patients had not previously been treated for hepatitis C, though some had genotype 1 infection that was resistant to standard medicines (consisting of either telaprevir or boceprevir – the so-called NS3/4A inhibitors - in combination with peginterferon alfa and ribavirin).

Around 99% of patients with genotype 1 infection (125 out of 126), 96% of patients with genotype 2 infection (25 out of 26) and 89% of patients with genotype 3 infection (16 out of 18) did not show any sign of the virus in their blood 12 weeks after the end of their planned treatment.

Additional studies involving patients with genotypes 4 indicate that Daklinza is also as effective against genotype 4 as it is against genotype 1.

What are the risks associated with Daklinza?

The most common side effects reported with Daklinza in combination with sofosbuvir with or without ribavirin are fatigue (tiredness), nausea (feeling sick) and headache. For the full list of all side effects reported with Daklinza, see the package leaflet.

Daklinza must not be used together with certain medicines that may reduce the effects of Daklinza. For more information on the medicines that should not be taken with Daklinza, see the package leaflet.

Why is Daklinza approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that Daklinza used in combination with other medicines was shown to be effective against hepatitis C virus, including in patients with genotype 1 resistant to previous treatment. Almost all the patients in the main study had the virus cleared from their blood.

Regarding its safety, Daklinza was well tolerated and the side effects were similar to those experienced by patients taking placebo.

The Committee therefore concluded that the benefits of Daklinza outweigh its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Daklinza?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Daklinza have been included in the summary of product characteristics and the package leaflet.

Further information can be found in the summary of the risk management plan.

Other information about Daklinza

The European Commission granted a marketing authorisation valid throughout the European Union for Daklinza on 22 August 2014.

For more information about treatment with Daklinza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Daklinza : EPAR - Summary for the public BG = bălgarski 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public ES = español 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public CS = čeština 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public DA = dansk 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public DE = Deutsch 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public ET = eesti keel 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public EL = elliniká 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public FR = français 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public IT = italiano 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public LV = latviešu valoda 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public LT = lietuvių kalba 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public HU = magyar 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public MT = Malti 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public NL = Nederlands 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public PL = polski 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public PT = português 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public RO = română 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public SK = slovenčina 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public SL = slovenščina 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public FI = suomi 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public SV = svenska 2014-09-15 2016-07-12
Daklinza : EPAR - Summary for the public HR = Hrvatski 2014-09-15 2016-07-12
Name Language First published Last updated
Daklinza : EPAR - Risk-management-plan summary (English only) 2014-09-15  

This EPAR was last updated on 15/09/2016 .

Authorisation details

Product details

Product details for Daklinza
NameDaklinza
Agency product numberEMEA/H/C/003768
Active substance

daclatasvir dihydrochloride

International non-proprietary name (INN) or common name

daclatasvir

Therapeutic area Hepatitis C, Chronic
Anatomical therapeutic chemical (ATC) code J05AX14
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Daklinza
Marketing-authorisation holder

Bristol-Myers Squibb Pharma EEIG

Revision8
Date of issue of marketing authorisation valid throughout the European Union22/08/2014

Contact address:

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park 
Sanderson Road 
Uxbridge UB8 1DH 
United Kingdom

Product information

Product information

19/10/2016  Daklinza -EMEA/H/C/003768 -II/0020

Name Language First published Last updated
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19
Daklinza : EPAR - Product Information EN = English 2014-09-15 2016-10-19

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.


Name Language First published Last updated
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12
Daklinza : EPAR - All Authorised presentations EN = English 2014-09-15 2016-07-12

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

Name Language First published Last updated
Daklinza : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2014-11-10 2016-10-19

Initial marketing-authorisation documents

Name Language First published Last updated
Daklinza : EPAR - Public assessment report EN = English 2014-09-15  
CHMP summary of positive opinion for Daklinza EN = English 2014-06-27