Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)

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Summary

 

Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B

Further studies needed to assess risk of liver cancer with these medicines

On 15 December 2016, the European Medicines Agency (EMA) confirmed its recommendation to screen all patients for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C; patients infected with both hepatitis B and C viruses must be monitored and managed according to current clinical guidelines. These measures aim to minimise the risk of hepatitis B re-activation with direct-acting antivirals.
Direct-acting antivirals (marketed in the EU as Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax)1 are important medicines for treating chronic (long term) hepatitis C, a disease of the liver caused by hepatitis C virus.

The review of direct-acting antivirals was carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). It looked into cases2 of returning signs and symptoms of previously inactive hepatitis B infection (re-activation) when patients were treated with direct-acting antivirals for hepatitis C.

The hepatitis B re-activation is thought to be the consequence of the rapid treatment-induced reduction in hepatitis C virus (as co-infection is known to suppress the hepatitis B virus) and the lack of activity of direct-acting antivirals against hepatitis B virus.

The PRAC recommendation to include a warning in the prescribing information about hepatitis B re-activation and how to minimise it was endorsed by EMA’s Committee for Medicinal Products for Human Use (CHMP).

In addition to data on hepatitis B re-activation, EMA also reviewed data suggesting that patients treated with direct-acting antivirals who have previously been treated for liver cancer could be at risk of their cancer returning early.

The CHMP agreed that companies should carry out a study to evaluate the risk of liver cancer returning with direct-acting antivirals. In this context, further research is also needed on the risk of new liver cancers in patients with chronic hepatitis C and cirrhosis (liver scarring) that are treated with direct-acting antivirals.

The CHMP’s opinion was passed to the European Commission, which issued a legally binding decision valid throughout the EU.

Information for patients

Direct-acting antiviral medicines (including Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax) are effective treatments for long-term hepatitis C that can be used without interferons (medicines known to have troublesome side effects).

  • If you also have hepatitis B virus infection, direct-acting antivirals for hepatitis C may cause the hepatitis B infection to become active again. Re-activation of hepatitis B may cause serious liver problems.
  • You will be tested for hepatitis B before starting treatment with direct-acting antivirals to check if you might be at risk of hepatitis B reactivation.
  • If you have both hepatitis B and C virus infections, your doctor will monitor you closely during and after treatment with direct-acting antivirals. You may also receive treatment for hepatitis B.
  • Tell your doctor if you have or have had hepatitis B infection. Speak to your doctor if you have any question or concern regarding your treatment.
Information for healthcare professionals

Cases of hepatitis B re-activation (with severe consequences) have been reported in patients co-infected with hepatitis B and C viruses treated with direct-acting antivirals. The frequency of such re-activation appears to be low.

  • Hepatitis B re-activation is thought to be caused by the rapid treatment-induced reduction in hepatitis C virus (as co-infection is known to suppress the hepatitis B virus) and the lack of anti-hepatitis B activity of direct-acting antivirals.
  • All patients should be screened for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C; patients co-infected with hepatitis B and C must then be monitored and managed according to current clinical guidelines.
  • Further studies are needed to evaluate the risk of recurring or newly diagnosed hepatocellular carcinoma in patients treated with direct-acting antivirals. Companies marketing these medicines have been asked to perform a prospective study to assess the risk of recurrence of previously treated hepatocellular carcinoma, and a prospective cohort study in patients with cirrhosis to assess the incidence and type of de novo hepatocellular carcinoma.
  • Therapeutic guidelines recommend that, in patients with advanced fibrosis and cirrhosis, surveillance for hepatocellular carcinoma should continue even after sustained viral response has been achieved.
More about the medicines

The review covered the following direct-acting antivirals for treating chronic hepatitis C: Daklinza (daclatasvir), Exviera (dasabuvir), Harvoni (sofosbuvir / ledipasvir), Olysio (simeprevir), Sovaldi (sofosbuvir) and Viekirax (ombitasvir / paritaprevir / ritonavir). Since the start of this review, two other direct-acting antivirals, Epclusa (sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir), have been authorised in the EU.

Direct-acting antivirals work by blocking the action of proteins which are essential for making new hepatitis C viruses.

More information on these medicines can be found on EMA’s website.

More about the procedure

The review of direct-acting antivirals for the treatment of hepatitis C was initiated on 17 March 2016 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004. On 14 April 2016 the scope of the review was extended to include the risk of liver cancer, in addition to the potential risk of hepatitis B re-activation.

The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.

The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency’s opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 23/2/2017.

Name Language First published Last updated
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B BG = bălgarski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B ES = español 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B CS = čeština 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B DA = dansk 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B DE = Deutsch 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B ET = eesti keel 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B EL = elliniká 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B EN = English 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B FR = français 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B IT = italiano 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B LV = latviešu valoda 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B LT = lietuvių kalba 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HU = magyar 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B MT = Malti 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B NL = Nederlands 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B PL = polski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B PT = português 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B RO = română 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B SK = slovenčina 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B SL = slovenščina 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B FI = suomi 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B SV = svenska 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  

Key facts

About this medicine

Approved nameDirect-acting antivirals indicated for treatment of hepatitis C (interferon-free)
International non-proprietary name (INN) or common name

daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/paritaprevir / ritonavir

Associated names
Class

About this procedure

Current statusEuropean Commission final decision
Reference numberEMEA/H/A-20/1438
TypeArticle 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of manufacturing or safety issues.

Decision making modelPRAC-CHMP-EC
Authorisation modelCentrally authorised product(s)

Key dates and outcomes

Procedure start date17/03/2016
PRAC recommendation date01/12/2016
CHMP opinion/CMDh position date15/12/2016
EC decision date23/02/2017
OutcomeRisk minimisation measures

All documents

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Name Language First published Last updated
Direct-acting antivirals for hepatitis C Article-20 procedure - PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C HR = Hrvatski 2016-12-02  

Opinion provided by Committee for Medicinal Products for Human Use

Name Language First published Last updated
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2016-12-16  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex III HR = Hrvatski 2016-12-16  

European Commission final decision

Name Language First published Last updated
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Sovaldi Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - PRAC assessment report HR = Hrvatski 2017-03-06  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Daklinza Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Exviera Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  
Direct-acting antivirals for hepatitis C Article-20 procedure - Harvoni Annex I-III HR = Hrvatski 2017-03-09  

Document description:

  • Annex I - List of the medicines affected by the referral
  • Annex II - Scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) or Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)
  • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
  • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
  • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
  • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
  • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
  • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
  • PRAC / CHMP / CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

Current status:
European Commission final decision