Official announcements
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Replacement
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Medicines
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09/08/2011
The marketing authorization holder informed its supplied customers in a letter dated August 9, 2011, that the release of the active ingredient may be accelerated in the three batches mentioned and that a replacement will therefore be carried out as a…
Replacement
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Medicines
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15/07/2011
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 Already on April 12, 2011, batches were withdrawn from the market after…
Replacement
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Medicines
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14/07/2011
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…
Replacement
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Medicines
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08/07/2011
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…
Replacement
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Medicines
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07/07/2011
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…
Recall
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Medicines
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30/06/2011
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…
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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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…