The marketing authorization holder informed its customers by letters dated July 10 and 13, 2012, that the patient-specific batches could have an elevated protein-nitrogen content and that the manufacturer could not rule out the possibility that the allergen concentration was also elevated.

Occurrence of a confirmed case in Palaio Faliro.

The following innovations are planned throughout Europe: Risk and risk managementAll medicinal products carry known and unknown risks at the time of their authorization. The previous version of Regulation 726/2004 already takes this knowledge into account by stipulating the mandatory submission of risk management plans (RMPs). The new legislation…

The marketing authorization holder informed its supplied customers in a letter dated July 2, 2012, that quality deviations were detected in current batches during stability tests. Therefore, as a precautionary measure, the delivery will be stopped and the goods on the market will be recalled by wholesalers and pharmacies.

Occurrence of a new case in the municipality of Marathon, Attica region.

The marketing authorization holder informed its supplied customers by letter dated 28.06.2012 that the transport carton of batch A010816 is labeled with the strength "Propofol ratiopharm 10 mg/ml emulsion for injection or infusion" (500 mg/50 ml), but there are 10 packages with the strength "Propofol ratiopharm 20 mg/ml Emulsion for Injection or…

The occurrence of venous thromboembolic events (VTE) is a rare but long-known adverse effect of combined oral contraceptives (COCs), which is explicitly mentioned in the technical and instructions for use of the preparations. Recent studies have shown that the risk associated with drospirenone-containing preparations is significantly higher than…

Recently, a quality defect was identified during further development of the product, according to which the epinephrine solution is not delivered or is delivered insufficiently in the event of an anaphylactic emergency.

Anapen (active ingredient: epinephrine) has been approved for the treatment of a state of shock (anaphylactic emergency) in some European member states, including Austria, since 2005. Recently, during the further development of the product, a quality defect was discovered, according to which the epinephrine solution is not or not sufficiently…

The distribution company has informed its supplied customers in a letter dated 01.06.2012 that there is a potential problem with the dispensing time and dispensing volume after the autoinjector has been triggered. This problem has arisen during the development of a new variant which is not yet on the market. The potential risk is a possible reduced…