Messages in brief
Use of codeine no longer indicated in children with cough under 12 years of age
The Federal Agency informs about recommendations of the Committee for Risk Assessment and Pharmacovigilance (PRAC, BASG initial notification…
Technical malfunction in the electronic transmission of adverse event reports
Dear registration holder,due to a technical malfunction in the period
from 20.09.2015 (15h) until 28.09.2015 (12h)
an electronic transmission of…
"Small import" of medicinal specialties
Small import" of medicinal specialities according to § 11 para. 1 Z 7 of the Austrian Medicinal Products Import ActTheFederal Office for Safety in…
Application of auto-injectors with the active substance adrenaline
The European Medicines Agency (EMA) recommends new measures to ensure the safe and successful use of epinephrine auto-injectors.
- Introduction of…
Medical Literature Monitoring by the EMA
On May 12, 2015, the European Medicines Agency (EMA) announced that - in accordance with Article 27 of Regulation (EC) No. 726/2004 - starting on July…
Online mail order for over-the-counter medicines launched
Registration of mail order pharmacies starts
Situation in Austria
As of June 25, 2015, remote sales of over-the-counter pharmaceutical specialties approved in Austria will be made possible.…
EMA questionnaire for children on the use of medicines and clinical trials
Measures at EU level
The European Medicines Agency (EMA) would like to increase the acceptance of participation of children and adolescents in…
Warning against use of new hepatitis C drugs with amiodarone
The Federal Office informs about recommendations of the European Medicines Agency EMA regarding a restriction of the use of new hepatitis C drugs…
Results of review of generic approvals with respect to potentially falsified bioequivalence studies in India.
Measures at EU level
An inspection at the research service provider GVK Biosciences in Hyderabad (India) revealed serious deficiencies in the…
