EU Regulation 536/2014 is expected to standardize the approval procedure for clinical trials throughout the EU from fall 2018. These are an essential part of drug development and, not least, provide objective proof of the effect and side effects of…

AGES Medical Market Surveillance launches a social media campaign from November 7 - 11, 2016 to increase willingness to report adverse reactions. Vienna (OTS) - In addition to positive effects, medicinal products can also have potential side effects.…

Legal trade in pharmaceutical specialties via the Internet was made possible in Austria in 2015 by an amendment to the Austrian Medicines Act and linked to legal requirements. Technical features on the drug provider's website enable consumers to…

European Union/European Economic Area (EU/EEA)Member States should consider a range of mitigation measures regarding the Zika virus epidemic

The marketing authorization holder informed its supplied customers in a letter dated October 12, 2016, that an impurity, "lmpurity D", was detected in the course of stability tests, which in the measured concentration does not indicate any health…

The marketing authorization holder informed its supplied customers in a letter dated October 13, 2016, that an impurity, "lmpurity D", was detected during stability tests. In the measured concentration there is no health risk for the patients. A…

The Federal Office for Public Health Safety has been informed by the Italian authority that WNV NAT testing will now be carried out in the province of Oristano (Region of Sardinia) in addition to the regions already announced.

Gedeon Richter Plc has informed their supplied customers by letter dated 12/10/2016 that above mentioned batches of "Lisvy 60 microgram/24 hours + 13 microgram/24 hours Transdermal Patch" are recalled. Stability data for these batches indicated a…

The Federal Office for Safety in Health Care has been informed by the Italian authority that WNV NAT testing will now be carried out in the province of Siena (Tuscany Region) in addition to the regions already announced.

Several cases of accidental overdose associated with Levetiracetam - Oral Solution have been reported throughout Europe. The majority of cases involved children between 6 months and 11 years of age. Many of these unintentional medication errors…