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 73 (4 pages).
| Date | Title | Link |
|---|---|---|
| 2013.05.16 |
New information for allocation of DCP slots |
to article |
| 2013.05.14 |
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 |
| 2013.05.14 |
Electronic submission of clinical trial applications BfArM and PEI publish a file structure for electronic data carriers (CD-ROM/DVD) for the submission of clinical trial applications for medicinal products. |
to article |
| 2013.05.02 |
Dear Doctor Letter (Rote-Hand-Brief) on Pletal® (cilostazol): New safety information As the result of a review of the benefits and risks of cilostazol and in collaboration with the European Medicines Agency, the indications for medicinal products containing cilostazol have been restricted. |
to article |
| 2013.05.02 |
Dear Doctor Letter (Rote-Hand-Brief) on Tavor® pro injectione 2 mg solution for injection (lorazepam): Recall Recall of Tavor® pro injectione 2 mg solution for injection due to possible contamination with glass splinters. |
to article |
| 2013.04.30 |
Increlex® 10 mg/ml solution for injection (mecasermin, recombinant human IGF-1): Temporary market shortage The company Ipsen Pharma GmbH is sending out information that the medicinal product Increlex® 10 mg/ml solution for injection will presumably be out of stock starting early August 2013. This shortage is due to manufacturing difficulties and the safety or efficacy of Increlex® already on the market is not affected. |
to article |
| 2013.04.24 |
AMG-Submission Ordinance The BfArM refers to FAQ concerning eCTD or NeeS as alternatives to AMG-EV. |
to article |
| 2013.04.23 |
Information Letter on CAELYX®: As of Monday 29 April 2013, supply with the medicinal product will return to normal Janssen-Cilag is sending out information that the supply with CAELYX® 2 mg/ml concentrate for solution for infusion is returning to regular availability and that the "CAELYX® Managed Access Programme" is being terminated. |
to article |
| 2013.04.08 |
Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene™ (thalidomide): Risk of second primary haematological malignancies The pharmaceutical manufacturer is sending out information on the risk of second primary haematological malignancies in patients treated with thalidomide. |
to article |
| 2013.04.08 |
Dear Doctor Letter (Rote-Hand-Brief) on INCIVO® (telaprevir): Occurrence of serious skin reactions The pharmaceutical manufacturer is sending out information on the occurrence of serious skin reactions associated with treatment with INCIVO®. |
to article |
| 2013.03.26 |
Dear Doctor Letter (Rote-Hand-Brief) on Mimpara® (cinacalcet): Occurrence of severe hypocalcaemia resulting in death Important safety-relevant information regarding a fatal case with severe hypocalcaemia in a clinical study in children and adolescents. |
to article |
| 2013.03.26 |
Information letter on NULOJIX® (belatacept): Increased occurrence of acute graft rejection The pharmaceutical manufacturer is sending out information on the increased occurrence of acute graft rejection under treatment with NULOJIX® (belatacept) associated with rapid corticosteroid taper in patients at high immunologic risk for acute rejection reactions. |
to article |
| 2013.03.25 |
Hydroxyethyl starch (HES): Start of an European safety review At the request of the BfArM, the European Medicines Agency (EMA) has initiated a review procedure regarding the basic evaluation of the benefit-risk balance of solutions for infusion containing hydroxyethyl starch (HES). |
to article |
| 2013.03.11 |
Dear Doctor Letter (Rote-Hand-Brief) on Fentanyl®-Janssen and Durogesic® SMAT (12, 25, 50, 75, 100 µg/h), transdermal patch (active substance: fentanyl): New warning New warning regarding medicinal products (and generics) containing fentanyl and the possible occurrence of serotonin syndrome if used concomitantly with serotonergic medicines. |
to article |
| 2013.02.25 |
Information Letter on NeuroBloc® (botulinum toxin type B): Risks related to "off-label“ use Serious adverse events were observed in connection with NeuroBloc® if used outside the licensed indication ("off-label“). |
to article |
| 2013.02.21 |
Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing tolperisone: Risk of hypersensitivity reactions The pharmaceutical manufacturers are sending out information on the restriction of the indication for medicinal products containing tolperisone and on the risk of hypersensitivity reactions. |
to article |
| 2013.02.21 |
Information letter on Optimark® products (gadolinium): New peel-off tracking label In order to enable a better understanding on the use of contrast agents containing gadolinium (Gd-based contrast agents) within the European Union, the European Commission has requested all manufacturers of contrast agents containing gadolinium to introduce peel-off tracking labels for these products. |
to article |
| 2013.02.20 |
Scientific and Regulatory Advice through the BfArM The BfArM has updated its website with respect to scientific advice procedures. |
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| 2013.02.14 |
Diane 35 and its generics: European safety review started In its February meeting (4 - 7 February 2013) the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has started a safety review of the medicinal product Diane 35 (which contains 2 mg cyproterone acetate and 35 µg ethinylestradiol) and its associated generics. |
to article |
| 2013.02.14 |
Combined hormonal contraceptives: European safety review started In its February meeting (4 - 7 February 2013) the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has started a safety review on combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, nomegestrol, norelgestromin or norgestimate as the gestagen component. |
to article |