Official announcements
Replacement
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Medicines
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28/06/2011
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…
Replacement
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Medicines
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28/06/2011
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 bromelain, the affected batch is being…
Replacement
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Veterinary Medicines
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15/06/2011
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.
Replacement
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Medicines
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06/06/2011
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.
Replacement
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Medicines
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30/05/2011
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…
Recall
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Medicines
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26/05/2011
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…
messages in brief
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23/05/2011
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…
Replacement
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Medicines
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11/05/2011
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…
Replacement
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Medicines
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05/05/2011
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…
Medicines
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05/05/2011
Decree concerning "Standards for the preparation for use, application and disposal of cytostatic drugs" (acc. to § 2 Z 12 GQG). See related files.
