The marketing authorization holder informed its supplied customers by letters dated October 29 and November 25, 2010, that the sterility of the products cannot be guaranteed for the batches listed above.

The marketing authorization holder has informed its supplied customers by letter dated 18.11.2010 that due to 5 complaints about visible particles after reconstitution of the product, which occurred in two batches of this medicinal speciality, the three above mentioned batches will be recalled as a precautionary measure and immediate replacement or…

Table 1: Product on the market and new application filed (65)*. Table 2: Product not on the market, new application filed (6)** Table 3: Product on the market, no new application filed (122)* Table 4: Product not on the market, no new application filed (551)** * Updated 02.05.2011 ** Updated on 03.05.2011 Queries: Univ.-Doz. Dr. Reinhard Länger…

Ebewe/Sandox has initiated a voluntary recall of certain lots of ebetraxate as a precautionary measure. See related file.

Due to a given occasion and due to inquiries regarding "innovations" in the field of traditional herbal medicinal products, the Federal Office for Safety in Health Care takes the liberty to inform about the current legal situation. The background of the current discussions is not a "new document" of the European Commission, but the transitional…

Ebewe/Santoz has initiated a voluntary recall of certain lots of 5-fluorouracil as a precautionary measure. See related file.

Notice of supply difficulties for PegIntron Powder and Solvent for Solution for Injection. See related file.

BASG/AGES PharmMed informs about the internal changeover of the E2B transmission of individual case reports, which was previously done via WebTrader, to gateway operation. The changeover will take place in October. For notifiers who have already successfully tested the electronic transmission of case reports to BASG or have already transmitted…

All eServices offered by BASG / AGES PharmMed will be available via this platform in the future. Currently, the following services can be accessed via the eServices navigation point: Non-interventional studies (NIS) : Public register of all NIS started in Austria as of 01.09.2010. Evaluations can be performed via the register and the result can be…

A notice from the Dutch government.