Messages in brief

News

No restriction of Rotarix and Rotateq

messages in brief | 21/05/2010

On March 17, 2010, the marketing authorization holder (GlaxoSmithKline Biologicals, GSK) informed the European Medicines Agency (EMA) that the oral…

No restriction of Rotarix and Rotateq Read more
News

Cancellation of marketing authorization for bufexamac-containing proprietary medicinal products

messages in brief | 26/04/2010

Based on a re-evaluation of the safety and efficacy data, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency…

Cancellation of marketing authorization for bufexamac-containing proprietary medicinal products Read more
News

Changed procedure for slot allocation for DC procedures

messages in brief | 31/03/2010

AGES PharmMed receives a large number of requests for decentralized procedures (DCP) and mutual recognition procedures (MRP) to act as procedure…

Changed procedure for slot allocation for DC procedures Read more
News

Generic Clopidogrel Replacement

messages in brief | 29/03/2010

On March 29, 2010, the delivery of generic drugs containing Clopidogrel, which used the active ingredient of the supplier Glochem Industries Ltd.,…

Generic Clopidogrel Replacement Read more
News

Chapter 7 update

messages in brief | 04/03/2010

The update of the general data for Austria was sent to the European Commission on 03.03.2010. The last update was in July 2008. Since the updated…

Chapter 7 update Read more
News

Medical Devices Act Amendment (MPG) 2009

messages in brief | 01/03/2010

On March 21, 2010, an amendment to the Medical Devices Act (MPG) (Federal Law Gazette I No. 143/2009 of December 30, 2009) will come into force.…

Medical Devices Act Amendment (MPG) 2009 Read more
News

Use of unapproved radiopharmaceuticals

messages in brief | 17/02/2010

Due to the current supply situation of certain radiopharmaceuticals, the Federal Office for Safety in Health Care (BASG)/AGES PharmMed points out…

Use of unapproved radiopharmaceuticals Read more
News

Doping warnings

messages in brief | 15/02/2010

On 31.12.2009 the AMG amendment BGBl. I No. 146/2009 came into force, and with it the provision according to which medicinal products containing…

Doping warnings Read more
News

Wafers with anabolic steroids

messages in brief | 28/01/2010

The OMCL of AGES PharmMed recently tested wafers from illegal production that were fortified with anabolic steroids. The wafers were produced in…

Wafers with anabolic steroids Read more
Email

Further inquiry note