Messages in brief
EudraVigilance New
After the European database EudraVigilance now fulfills all functionalities required by Regulation (EC) No. 726/2004, these have been positively…
Austrian guideline for the designation of medicinal specialties
The new guide summarizes rules and recommendations related to designations and names of human and veterinary drug specialties and is intended to…
Drug Safety Information Platform
Extended recall of EpiPen 300 micrograms and EpiPen Junior 150 micrograms solution for injection in a prefilled pen (epinephrine)
EpiPen 300 microgram solution for injection in a ready-to-use pen (epinephrine) and EpiPen Junior 150 microgram solution for injection in a…
Austrian Medicines Agency is a member of ICMRA
The International Coalition of Medicines Regulatory Agencies (ICMRA) admitted the Federal Office for Healthcare Safety/AGES Medical Market…
Recall of "EpiPen 300 micrograms solution for injection in a ready-to-use pen".
EpiPen 300 micrograms solution for injection in a ready-to-use pen (epinephrine) has been approved under the MRP/DCP procedure since March 30, 1998…
Drug regulatory authorities: Cooperation between Switzerland and Austria
Swissmedic , the Swiss Agency for Therapeutic Products, wants to work more closely with its partner authority in Austria. Swissmedic Director Jürg…
Reminder: private sale of medicines prohibited
Due to current events (see screenshot), the Federal Office for Safety in Health Care points out that according to §59 of the Medicines Act, private…
Possible interactions with "morning-after pill" - double dose or copper IUD required
New recommendations for levonorgestrel emergency contraceptives in case of interactions with CYP3A4-inducing drugs.
In Austria, the current…
