Human medicines
Ebetrexat
Ebewe/Sandox has initiated a voluntary recall of certain lots of ebetraxate as a precautionary measure.
See related file.
5-Fluorouracil
Ebewe/Santoz has initiated a voluntary recall of certain lots of 5-fluorouracil as a precautionary measure.
See related file.
PegIntron
Notice of supply difficulties for PegIntron Powder and Solvent for Solution for Injection.
See related file.
Ionsys (fentanyl)
The following quality defect has been identified in the drug product Ionsys (Fentanyl) 40 microgram per dose iontophoretic transdermal system:
A…
Brombutyl
Exchange of unbuffered and weakly buffered infusion solutions.
See associated files.
Neupro
Information to ensure the safety of Neupro.
See related files.
Gardasil
Communication from the Federal Office for Safety in Health Care on Gardasil.
You related file.
Trasylol
Information on the suspension of marketing of parenterally administrable drug products containing aprotinin.
See related files.
Silomat
Information on market withdrawal of Clobutinol-containing drugs (Silomat®) up to and including patient level.
See related files.
Open applications for approval
Information on processing open registration and amendment requests submitted prior to Jan. 1, 2006.
See related file.