The distribution partner Croma-Pharma has informed the supplied customers by letter dated December 9, 2010, that the above mentioned batches have to…

The marketing authorization holder informed its supplied customers in a letter dated December 13, 2010, that the affected batch exhibited significant…

The marketing authorization holder informed its supplied customers by letters dated October 29 and November 25, 2010, that the sterility of the…

The marketing authorization holder has informed its supplied customers by letter dated 18.11.2010 that due to 5 complaints about visible particles…

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

See related file.

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.

The following quality defect has been identified in the drug product Ionsys (Fentanyl) 40 microgram per dose iontophoretic transdermal system:

A…

Exchange of unbuffered and weakly buffered infusion solutions.

See associated files.

Information to ensure the safety of Neupro.

See related files.