Official announcements
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…
Safety warnings
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messages in brief
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01/07/2011
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…
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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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…