Ukrain is a medicinal product made from celandine extracts produced by the pharmaceutical company Nowicky Pharma. The drug was advertised in the EU as an alternative cancer treatment without a valid marketing authorization. In Austria, Nowicky Pharma was prohibited from importing, manufacturing and marketing Ukrain by official notice. On September…

The parallel distributor, HAEMATO PHARM AG; has informed its supplied customers by letter dated 5.9.2012 that the batches placed on the market by him are recalled, because tablets were found which are light blue and have "GILEAD" as tablet embossing. However, the tablets approved for use in the EU are blue and embossed with "GILEAD" on one side and…

Occurrence of new diseases in the districts of Ialomita, Giurgi as well as city of Bucharest.

In accordance with Section 1 (3b) of the Austrian Medicines Act, Federal Law Gazette No. 185/1983, as amended, the following official demarcation has been made in response to questions submitted to the Federal Office for Safety in Health Care with regard to the demarcation of live animals as medicinal products. Basic information on the definition…

The marketing authorization holder informed its supplied customers in a letter dated August 27, 2012, that in the course of stability tests at the manufacturer Ben Venue Laboratories, Ohio, USA, an overfill was detected in a single dry-stone ampoule of a single batch. As a precautionary measure, the marketing authorization holder is now recalling…

Dealing with people willing to donate from various areas of Romania.

The distribution partner sanofi-aventis GmbH Austria informed its supplied customers by letter dated August 13, 2012, that aggregates above the specification limit of 5% occurred after reconstitution of reserve samples of a batch sold in the USA. As a precautionary measure, a recall has been initiated for batches produced during the same period and…

Emergence of new confirmed cases in the province of Venezia.

Misleading wording in package insert, see related file.

Packaged finished product batches as of May 2011 contain incorrect information in the package insert, see associated file.