Official announcements
Replacement
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Medicines
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24/10/2011
The marketing authorization holder informed its supplied customers in a letter dated October 24, 2011, that a precautionary recall is being carried out due to an increased number of suspected cases of adverse drug reactions that occurred within a…
messages in brief
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17/10/2011
On Oct. 11, 2011, the European Commission published revised proposals to amend Regulation (EC) No. 726/2004 and to amend Directive 2001/83/EC. The content of these proposals is to clarify the form in which companies may inform the public about…
Recall
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Medicines
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11/10/2011
The distributor has informed its supplied customers by letter dated 04.10.2011 that the affected batch has a labeling error: On the folding boxes, the expiration date is poorly legible and stamped with the wrong year (Aug. 31, 2013 instead of the…
Medicines
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10/10/2011
Ophthalmologists have informed the Federal Office for Safety in Health Care that the drug Flurekain "Croma" Eye Drops is no longer available. See related files.
messages in brief
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29/09/2011
The BMF, BMI, BMG and BASG participated in this year's action week. The operation took place this year from 20.09. to 29.09.2011. A total of 84 countries participated in the organized action. The aim was to simultaneously and in a coordinated manner…
messages in brief
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28/09/2011
The World Health Organization (WHO) has recognized the EU Clinical Trials Register (CTR) as the primary registry for the International Clinical Trials Registry Platform (ICTRP), a web-based portal that contains information from a number of clinical…
messages in brief
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27/09/2011
Commission Regulation (EC) No. 1234/2008 of Nov. 24, 2008, concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products (Variation-Regulation), governs…
messages in brief
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27/09/2011
Since 01.09.2011 the new harmonized validation criteria are in force. From now on, the validation of dossiers includes the following criteria: Pass/Fail (P/F) and Best Practice (BP). A dossier is considered valid if all Pass/Fail criteria have been…
Safety warnings
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messages in brief
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23/09/2011
The preparations Xenical and Alli Vimpat (active ingredient: orlistat) have been approved throughout Europe since 1998 and 2007, respectively, for weight reduction in adults with overweight (body mass index BMI≥28 kg/m2 in combination with a mildly…
Recall
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Medicines
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16/09/2011
The marketing authorization holder informed its supplied customers in a letter dated September 15, 2011, that crystalline particles may be present in the amino acid chamber of the three batches mentioned and that a recall is therefore being carried…