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…

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 defect in the IONSYS systems may potentially cause the system to self-activate. See related files.

Exchange of unbuffered and weakly buffered infusion solutions. See associated files.

Information to ensure the safety of Neupro. See related files.

Communication from the Federal Office for Safety in Health Care on Gardasil. You related file.

Information on the suspension of marketing of parenterally administrable drug products containing aprotinin. See related files.