Official announcements
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…
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…