Official announcements
Recall
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Medicines
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15/09/2011
The marketing authorization holder, in agreement with the European Medicines Agency (EMA), has informed its supplied customers by fax dated September 14 that all batches of Vimpat Syrup are being recalled. The reason for this recall is precipitation…
messages in brief
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13/09/2011
The QRD (Quality Review of Documents) working group of the European Medicines Agency (EMA) published the new version of the QRD template for central procedures at the end of July 2011. The template for MR/DC or referral procedures followed at the end…
messages in brief
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12/09/2011
The proposals are intended to harmonize the pharmacovigilance system provided for in Regulation (EU) No. 1235/2010 and Directive 2010/84/EU. To this end, implementing measures have been developed by the European Commission in the following areas: the…
Replacement
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Medicines
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08/09/2011
The marketing authorization holder informed its supplied customers in a letter dated 07.09.2011 that due to individual reports of an unpleasant, moldy odor, a further batch must be recalled. This odor emanates from the primary packaging (plastic…
Safety warnings
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messages in brief
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01/09/2011
Orally administered isotretinoin is highly teratogenic and strictly contraindicated in pregnancy. Reliable pregnancy prevention is therefore essential when using isotretinoin (Ciscutan®, various generics). Prescribing, dispensing and taking…
Recall
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Medicines
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30/08/2011
The distribution company has informed its supplied customers by letter dated August 29, 2011, that the batches indicated above may be contaminated with particles and are therefore recalled as a precautionary measure.
messages in brief
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29/08/2011
With the new DCP-slot alert mailing list applicants have the opportunity to be informed immediately whenever a new version of the availability matrix has been published. In the availability matrix free resources in the different assessor groups for…
Replacement
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Medicines
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24/08/2011
The marketing authorization holder has informed its supplied customers by letter dated 23.08.2011 that a replacement will be carried out due to crystallization of the calcium solution. Note: On 06.06.2011, the batches L108003 and L118002 were already…
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…