Messages in brief
No restriction of Rotarix and Rotateq
On March 17, 2010, the marketing authorization holder (GlaxoSmithKline Biologicals, GSK) informed the European Medicines Agency (EMA) that the oral…
Cancellation of marketing authorization for bufexamac-containing proprietary medicinal products
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…
Changed procedure for slot allocation for DC procedures
AGES PharmMed receives a large number of requests for decentralized procedures (DCP) and mutual recognition procedures (MRP) to act as procedure…
Generic Clopidogrel Replacement
On March 29, 2010, the delivery of generic drugs containing Clopidogrel, which used the active ingredient of the supplier Glochem Industries Ltd.,…
Chapter 7 update
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…
Medical Devices Act Amendment (MPG) 2009
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.…
Use of unapproved radiopharmaceuticals
Due to the current supply situation of certain radiopharmaceuticals, the Federal Office for Safety in Health Care (BASG)/AGES PharmMed points out…
Doping warnings
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…
Wafers with anabolic steroids
The OMCL of AGES PharmMed recently tested wafers from illegal production that were fortified with anabolic steroids. The wafers were produced in…
