The marketing authorization holder informed its supplied customers by letter dated 06.06.2011 that a precautionary recall is being carried out due to three reports of crystallization of the calcium solution.

The marketing authorization holder informed its supplied customers in a letter dated May 26, 2011, that the degradation product prostaglandin A1 (PGA1) was above the specified limit at the end of the 24-month period and thus a replacement had to be carried out.

The marketing authorization holder informed its supplied customers in a letter dated May 20, 2011, that the content of available iodine in the three batches listed above may fall slightly below the specification limit before expiry of the shelf life and that a recall therefore had to be carried out.

The "Standards for the Preparation for Use, the Application and the Disposal of Cytostatic Drugs" are quality standards according to § 2 Z 12 of the Health Care Quality Act (GQG). These standards concern health care facilities and summarize the essential measures to ensure the protection of persons and to guarantee flawless drug quality. The BMG…

The marketing authorization holder informed its supplied customers in a letter dated May 11, 2011, that due to reports of an unpleasant, moldy odor, the affected batches must be recalled. This odor emanates from the primary packaging (plastic bottles) and is due to contamination with traces of 2,4,6-tribromoanisole (TBA). TBA is a degradation…

The marketing authorization holder informed its supplied customers by letter dated May 3, 2011, that an atypically elevated value of a known, characterized degradation product was detected in the batches listed above. However, the values are within the specification of the product. In order to prevent an overspecification from occurring within the…

Decree concerning "Standards for the preparation for use, application and disposal of cytostatic drugs" (acc. to § 2 Z 12 GQG). See related files.

Based on recent follow-up requests from the Drug Quality and Regulatory Affairs National Procedures Divisions, a list of the most frequently submitted complaints was compiled. In each case, the "Top Five" for new and renewal requests are summarized below. By taking these suggestions to heart, you will increase dossier quality and thus also shorten…

On May 3, 2011, the Ordinance of the Federal Office for Safety in Health Care on the Electronic Transmission of Applications and Notifications (Electronic Submission Ordinance 2011 - EEVO 2011) was published in the Official Gazette of the Federal Office for Safety in Health Care. The purpose of this ordinance is to make use of the power to issue…

Hip joint endoprostheses are medical devices of the highest risk class (class 3). These medical devices must undergo a development program with clinical studies. If the benefit-risk profile is appropriate, the device is certified by a notified body and may be used as a result. This benefit-risk profile is continuously evaluated within the framework…