Official announcements
Replacement
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Medicines
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16/08/2011
The marketing authorization holder informed its supplied customers in a letter dated August 12, 2011, that individual tablets may break when they are pressed out of the blister and that this batch will therefore be replaced.
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…
messages in brief
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05/08/2011
On 05.08.2011, the Federal Office for Safety in Health Care sent a draft of the "Regulation of the Federal Office for Safety in Health Care amending the Regulation of the Federal Office for Safety in Health Care on the Fee Tariff pursuant to the GESG…
messages in brief
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05/08/2011
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…
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 Already on April 12, 2011, batches were withdrawn from the market after…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…
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…