Messages in brief
PSUR repository mandatory in force as of June 13
Due to legal requirements (Reg. (EC) 726/2004, Article 25a), EMA is obliged to set up a database for periodic safety update reports (PSUR) and the…
Pyrrolizidine alkaloids in medicinal products
Recently, pyrrolizidine alkaloids have also been detected in herbal preparations made from plants that do not biosynthesize pyrrolizidine alkaloids.…
Christa Wirthumer-Hoche elected Chairwoman of the EMA Management Board
At the European Medicines Agency (EMA) Management Board meeting in London on March 17, 2016, Christa Wirthumer-Hoche was elected Chair of the EMA…
Electronic application form (eAF)
HPV vaccination - no causal relationship with CRPS and POTS.
A re-examination of the safety and efficacy of human papillomavirus vaccines (HPV vaccines) has been completed. After evaluation of the current data…
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…
