• Increase font size
  • Default font size
  • Decrease font size
Information for citizens
Information for medical specialists
Information for companies
««« IMPORTANT! »»»
Pharmacovigilance / «Companies»

Single, central platform now mandatory for all periodic safety update reports

PSUR repository facilitates information exchange on the safety of human medicines authorised in the EU

As of 13 June 2016, all periodic safety update reports (PSURs) for human medicines authorised in the European Union (EU) must be submitted to the PSUR repository, which has been developed by the European Medicines Agency (EMA) in close collaboration with EU Member States and the industry.

More information on this is included in the hyperlink below:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/06/news_detail_002547.jsp&mid=WC0b01ac058004d5c1

 
Information for citizens

The PRAC has concluded a review of a meta-analysis of data from three observational studies (1-3) assessing the risk of developing antibodies against recombinant factor VIII products in previously untreated patients (PUPs) with severe haemophilia A (factor VIII level < 1%). Inhibitor development is the most serious and challenging complication in the treatment of haemophilia A.

More information on this is included in the hyperlink below:

13 May 2016; EMA/PRAC/332348/2016

 
Information for citizens

EMA reviews direct-acting antivirals for hepatitis C

On 17 March 2016, the European Medicines Agency (EMA) started a review of medicines known as direct-acting antivirals used for treating chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).

Direct-acting antivirals (Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax) are important medicines for the treatment of chronic hepatitis C and can be used without interferons, which are less well tolerated. Until recently, interferons were part of treatment regimens for hepatitis C. Interferons are known to act against both hepatitis B and C viruses, which may be present at the same time in some patients.

The review was triggered by reports of hepatitis B re-activation in patients who have been infected with hepatitis B and C viruses, and who were treated with direct-acting antivirals for hepatitis C. Hepatitis B re-activation refers to a return of active infection in a patient whose hepatitis B infection had been inactive. The review will assess the extent of hepatitis B re-activation in patients treated with direct-acting antivirals for hepatitis C and evaluate whether any measures are needed to optimise the treatment.

In addition, in April 2016 data from a study1 became available regarding the risk of liver cancer (hepatocellular carcinoma) coming back in patients who were treated with direct-acting antivirals for hepatitis C. The study suggested that these patients were at risk of their cancer coming back earlier than patients with hepatitis C who were not treated with direct-acting antivirals. The scope of the ongoing review has therefore been extended to also assess the risk of liver cancer with these medicines. While the review is ongoing, patients should speak to their doctor or pharmacist if they have any questions or concerns.

More information on this is included in the hyperlink below:

EMA reviews direct-acting antivirals for hepatitis C

 
Top