Welcome to the Federal Institute for Drugs and Medical Devices
The English web pages of the Federal Institute for Drugs and Medical Devices contain selected items from its German language site. The focus is on information giving an overview about the tasks and aims of the institute. Departments and units are introduced and provide an overview on their scientific work. Additional information is available at the respective German internet sections. The English site will be continuously expanded.
Search results 1 to 20 from a total of 50 (3 pages).
| Date | Title | Link |
|---|---|---|
| 2010.08.17 |
Update of BfArM eValidator (Software for technical validation of e-submissions) The new hotfix switches off the mutability of rule severity levels to avoid changes by mistake and prevent confusion for customers. Links to multiple referenced files will no longer considered as error as long as they stated in the same index file, i.e. also the same sequence. The revised version of the NeeS Guidance Document, dated March 2010, has been taken into account. Node extensions, which are allowed for the EU, will be informed about. Applicants are strongly advised to re-download the ZIP container and to update their local installation. |
to article |
| 2010.08.13 |
Angiotensin-receptor-antagonists: BfArM and EMA are assessing studies on the risk of cancer. In June 2010 “Lancet Oncology“ published the results of a meta-analysis (Sipahi et al., 2010), in which the authors observed a slightly increased risk for new cases of cancer under angiotensin-receptor-antagonist therapies. |
to article |
| 2010.08.12 |
Dear Doctor letter on Xyrem® (sodium oxybate): Risk of dosing errors Risk of dosing errors with Xyrem® (sodium oxybate) because gramme (g) and milliliter (ml) are easily confused. |
to article |
| 2010.08.09 |
Dear Doctor Letter (Rote-Hand-Brief) regarding Ketoprofen, topical formulations Important safety information about the risk of photosensivity reactions in association with topical uses of Ketoprofen. |
to article |
| 2010.07.27 |
BfArM recommends not to implant silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP) |
to article |
| 2010.07.26 |
Dear Doctor letter (Rote Hand Brief) on Cardioxane® (dexrazoxane): Secondary neoplasia in children Important safety information on Cardioxane® (dexrazoxane) and increased risk for secondary neoplasia in children. |
to article |
| 2010.07.23 |
Rosiglitazone: The BfArM and the EMA emphasise restrictions in indications In July 2010 the CHMP at the EMA initiated assessment of new study results on the antidiabetic, rosiglitazone. The BfArM, like the CHMP, is repeating the advice that the long-existing restrictions in rosiglitazone indications should be strictly observed by prescribing physicians. |
to article |
| 2010.07.21 |
Dear Doctor letter on Perfalgan® (paracetamol i.v.): Correction Correction of the letter on Perfalgan® (paracetamol i.v.) |
to article |
| 2010.07.16 |
Rosiglitazone: The EMA initiates assessment of new study results In July 2010 the CHMP at the EMA is assessing the recently published new study results on rosiglitazone (June 2010). |
to article |
| 2010.07.15 |
Dear Doctor letter on Invirase® (active substance: saquinavir): QT-prolongations Additional safety information on the arrhythmogenic risk due to QT and PR interval prolongations in association with Invirase (saquinavir). |
to article |
| 2010.07.14 |
Dear Doctor letter on Perfalgan® (paracetamol i.v.): Inadvertent overdose in newborn babies and infants Important information on the risk of inadvertently overdosed intravenous infusion of paracetamol 10 mg/ ml to newborn babies and infants. |
to article |
| 2010.07.13 |
HMA Strategy Paper II (Draft 2010 for consultation) The European Heads of Medicines Agencies (HMA) group is currently developing a second HMA strategy document for the period 2011-2015, which it aims to have finalised and published by the end of 2010. As part of the strategy development process, and in line with good practice, the HMA intends to consult with key stakeholder groups on the strategy’s content. |
to article |
| 2010.07.09 |
Dear Doctor letters on temozolomide: Recall For precautionary reasons the pharmaceutical companies will recall certain batches of temozolomide. |
to article |
| 2010.07.01 |
AMG-Submission Ordinance On 1 July 2010, the BfArM published the new BfArM key. The validity of which expires on 10 January 2011. Note: The validity period of the key published on 1 January 2010 will expire on 12 July 2010. |
to article |
| 2010.06.17 |
„Flying Team“ Pioglitazone – Expiry of data protection on 13.10.2010 The BfArM will, from 13. Oktober 2010, accept generic applications for Pioglitazone 15 mg and 30 mg tablets. Taking into account the number of DCP submission requests already received, the BfArM has decided to open a further „Flying Team“ project aiming at shortened timelines for submission and evaluation. |
to article |
| 2010.06.17 |
Valproic acid/valproate: Interaction with carbapenems The product information texts on all valproic acid or products containing valproates should include warnings about clinically relevant interactions with carbapenems (decreased valproate plasma concentration) to come up to the latest findings. The intended measures are due to an EU recommendation. A hearing in writing under the graduated plan procedure (Stufenplan), stage II, will follow. |
to article |
| 2010.06.16 |
Several links have changed on BfArM subpages Please note that the addresses of several links have changed due to a technical update of the underlying content management system. Please check both the bookmarks on BfArM subpages as well as the addresses of the RSS newsfeeds you use. |
to article |
| 2010.06.14 |
Information on WHO Certificates issued by the BfArM in accordance with Section 73a sub-section 2 AMG In accordance with Section 73a sub-section 2 AMG, the BfArM issues a certificate corresponding to the World Health Organisation's Certification Scheme, at the request of the pharmaceutical entrepreneur located outside the scope of the German Medicines Act (Arzneimittelgesetz, AMG) as far as the information relates to licensing issues. |
to article |
| 2010.05.05 |
Bufexamac-containing products for topical use A two-year period for selling bufexamac-containing products cannot be granted according to BfArM’s Feststellungsbescheid (ascertainment decision). Prior to the BfArM order the authorisation holders had abandoned their marketing authorisations in Germany. |
to article |
| 2010.05.03 |
Information letter on Exelon® and Prometax® transdermal patches (active substance: rivastigmine): incorrect administration and medication error In association with the rivastigmine transdermal patches, Exelon® and Prometax®, cases of overdosage due to medication errors and incorrect administration have been reported. |
to article |