On August 5, 2011, the Federal Office for Safety in Health Care sent a draft of the "Ordinance of the Federal Office for Safety in Health Care on the Collection, Payment and Determination of the Amount of a Medical Device Fee (Medical Device Fee Ordinance 2011)" for review. All interested and affected parties are invited to submit any comments on…

The marketing authorization holder informed its supplied customers in a letter dated July 7, 2011, that another batch that had exceeded the 18-month shelf life would be replaced. Already on April 12, 2011, batches were withdrawn from the market after it had to be determined that the occurrence of visible particles is possible if the runtime of 18…

In a letter dated July 13, 2011, the marketing authorization holder informed its supplied customers that, in addition to the tablets, glass splinters may also be present in the amber glass vials. These particles are caused by chipping of the bottle neck and can occur with a probability of 0.1%.

In a letter dated July 7, 2011, the marketing authorization holder informed its customers that stability tests had revealed that the active ingredient content had been exceeded and that the batch concerned would therefore be replaced as a precautionary measure.

The marketing authorization holder informed its supplied customers in a letter dated July 5, 2011, that due to a calculation error an incorrect expiration date was printed on the label and folding box. The expiration date is indicated as 11/2012 instead of the correct 11/2011. There is currently no risk to patients, as the affected batch would in…

Ketoprofen-containing proprietary medicinal products are approved for the local symptomatic therapy of pain conditions, mainly in the field of traumatology and rheumatology. Due to reports of light-allergic reactions, the risk-benefit balance of these proprietary medicinal products was evaluated on a pan-European level under an Article 107…

The medicinal product imported from Switzerland is being recalled as a precautionary measure, as stability tests have shown that the specified active ingredient content cannot be guaranteed until the end of the product's shelf life. A letter to this effect was sent by "Roche Austria GmbH" to the supplied customers on June 29, 2011.

The marketing authorization holder informed its supplied customers in a letter dated June 28, 2011, that due to a minor deviation (falling below the specification limit) in the active ingredient activity of papain, the affected batch is being recalled as a precautionary measure.

The marketing authorization holder informed its supplied customers in a letter dated June 28, 2011, that due to a minor deviation (falling below the specification limit) in the active ingredient activity of bromelain, the affected batch is being recalled as a precautionary measure.

The marketing authorization holder informed its supplied customers in a letter dated June 15, 2011, that a replacement would be carried out due to visible particles in the reserve samples.