"MEDIKUS medizintechnische und pharmazeutische Vertriebs GmbH" informed its customers on April 26, 2019 that metallic particles were detected in the infusion bags.

Article 54 of the MDR regulates the consultation procedure related to the clinical evaluation of certain class III and class IIb devices. Regarding the exemption provisions to this procedure, an interpretative document has been published. Devices under the directives (AIMDD, MDD, IVDD) may be placed on the market, made available on the market or…

The purpose of the ‚Draft guideline on the non-clinical requirements for radiopharmaceuticals‘ (EMA/CHMP/SWP/686140/2018) is to provide guidance on the required nonclinical data needed to support clinical development and marketing authorisation of radiopharmaceuticals. Radiopharmaceuticals are a special, but clinically important group of medicinal…

The marketing authorisation holder informed its customers on April 4, 2019 that there is a risk that "Parkemed - Suspension zur oralen Anwendung" will likely contain levels of Lead (Pb) and Lithium (Li) which exceed the Permitted Daily Exposure (PDE) levels.

The marketing authorisation holder informed its customers on March 6, 2019 that the marketing of „Tetraspan 60 mg/ml Infusionslösung“ and „Venofundin 60 mg/ml Infusionslösung“ is ceased permanently for economic reasons.

The marketing authorisation holder informed its customers on February 19, 2019 that the marketing authorisation of „Vantobra 170 mg Lösung für einen Vernebler“ will be withdrawn.

For more information on this topic, follow the link to the security features .

The parallel distributor „HAEMATO PHARM GmbH“ informed its customers on February 14, 2019 that the supply chain is not fully documented and GDP-guidelines are not met.

During the transitional phase, strict limits are already in place for these impurities.

During the transitional phase, strict limits are already in place for these impurities.