Recall due to a possible incorrect closure of the crimp caps

Das BASG warns against the product "Prostapax Forte", because it is categorised as an illegal medicinal product (medicinal product by presentation) due to its claims in the advertising brochure.

Recall due to a possible incorrect closure of the crimp caps

This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.

The committee on herbal medicinal products (HMPC) of the European Medicines Agency (EMA) published the revised Public Statement on the use of herbal medicinal products1 containing estragole.

Recall of a batch due to visible crystalline particles

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that one offspring of donor 8212 WITTE has been diagnosed with autosomal recessive hearing loss 77 (DFNB77).

Recall due to possible non-sterility

Recall due to exceeding the limit value of the parameter "known impurities"

Up-to-date information from the 19.02.-22.02.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.