The Federal Office for Safety in Health Care (BASG) informs about new developments concerning counterfeits of the medicinal product Ozempic® (manufacturer: Novo Nordisk A/S). The existing BASG warnings of 12/10/2023, 19/10/2023 and 23/10/2023 remain valid. The manufacturer's mailing is supplemented with comprehensive patient information.

BASG informs about current developments and necessary measures in case of counterfeiting of the medicinal product Ozempic® in German presentation.

Up-to-date information from the 11.09.-14.09.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

is required. If the physician sample labelling is carried out by a qualified manufacturer as an activity on behalf according to Section 29 AMBO 2009, approval of this manufacturer in the dossier of the [...] the establishment (including inventory number). - Premises and, if applicable, equipment (coolers, active transport boxes, etc.) shall be qualified and maintained in accordance with GMP/GDP requirements [...] item 1.4.3 "Other" in the scope of authorisation of drug manufacturers, or under item 2.5 "Other activities" in the scope of authorisation of drug wholesalers. A list of overused equipment/compartments is

Recall due to increased release of active ingredient

On Friday 18.8.2023 a delegation of the Chinese Drug Administration Zhejiang Medical Products Administration visited the AGES Medical Market Surveillance for an exchange and deeper insights into the fields of activity.

Recall due to slightly increased peroxide number

Up-to-date information from the 17.07.-20.07.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

10 years after the review of iron-containing drugs for intravenous use associated with allergic reactions, cautions are recalled.

The BASG warns against potency enhancers seized in Austria that contain undeclared synthetic active pharmaceutical ingredients, such as sildenafil or tadalafil.