Official announcements
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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…
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…
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…
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…
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…
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…
messages in brief
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23/05/2011
The "Standards for the Preparation for Use, the Application and the Disposal of Cytostatic Drugs" are quality standards according to § 2 Z 12 of the Health Care Quality Act (GQG). These standards concern health care facilities and summarize the…
messages in brief
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04/05/2011
Based on recent follow-up requests from the Drug Quality and Regulatory Affairs National Procedures Divisions, a list of the most frequently submitted complaints was compiled. In each case, the "Top Five" for new and renewal requests are summarized…