The parallel distributor has informed its supplied customers in a letter dated 16.04.2014 that Herceptin in Italian presentation has been adulterated and introduced into the legal distribution chain. Therefore, a recall of the above mentioned Italian…

by patients, as a particularly high standard of care must be applied to these products. Moreover, evaluation of exemption requests is always a matter of product-specific decisions on a case-by-case basis [...] of a marketing authorisation according to § 25 AMG In case of a change of ownership according to § 25 AMG the granted exemption(s) is/are transferred to the future marketing authorisation holder. A new [...] granted according to § 16(6) and § 17(10) AMG are permanent exemptions without a time limit. However, if there are changes to the product during the life-cycle that also lead to a significant change in

Referenced at:

• Life-Cycle
• Life-Cycle

The distribution company informed its supplied customers on 04/16/2014 and asked for a stock check of the affected batch.

Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der italienischen Behörde mitgeteilt, dass zwei Blutspender in den Provinzen Mantova und Cremona (Region Lombardia) WNV NAT positiv getestet wurden. Weiters wurde von vier symptomatischen humanen WNV-Fällen (davon zwei neuroinvasive Erkrankungen) in den Provinzen Verona, Rovigo (RegionVeneto) und Reggio Emilia (Region Emilia Romagna) berichtet.

Referenced at:

• WNV Risk Areas Italy - Update

The marketing authorization holder informed its supplied customers in a letter dated June 16, 2014, that the manufacturer cannot rule out the possibility that the solution in individual bottles is contaminated with small black particles, so that a…

The marketing authorization holder informed its supplied customers in a letter dated August 16, 2018, that due to quality problems with one batch of ampoules, batch D1K13 is being recalled as a precautionary measure.

The Federal Office for Safety in Health Care was informed by the Danish authority that it had been informed by the Danish tissue bank Cryos International (DK257551) of a termination of a pregnancy at 16 weeks' gestation due to abnormalities of the fetus in all four limbs. The report describes the clinical picture arthrogryposis multiplex congenita (AMC).

The marketing authorization holder has informed its supplied customers in a letter dated November 16, 2018, that isolated impurities or contamination of the film-coated tablets have been detected, which occurred during the packaging of the…

advice meeting is scheduled for a maximum of 2 hours. The meeting will be chaired by a BASG representative. After a round of welcome and introduction, the applicant shall give a presentation of the background [...] applying for Scientific Advice Item 5 If the application is submitted by a legal representative of the Applicant (e.g., a consultant), a letter of authorisation specific to the consultant and procedure in question [...] application form, the applicant is asked to attach a document containing a List of Questions, including justifications of the applicant’s positions. A template for this List of BASG / Austrian Medicines

Referenced at:

• Scientific advice by BASG

Dem Bundesamt für Sicherheit im Gesundheitswesen (BASG) wurde von der französischen Behörde mitgeteilt, dass in Frankreich, zusätzlich zu den bereits bekannt gegebenen Regionen, bestätigte autochthone Dengue-Fälle im Département Lot verzeichnet wurden.

Referenced at:

• Update: Dengue - France and overseas territories