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 100 (5 pages).
| Date | Title | Link |
|---|---|---|
| 2012.05.11 |
Information letter on Protopic® (tacrolimus): Recommendations for the correct use Important recommendations for the correct use of Protopic® (0.03% and 0.1%) Ointment in order to minimise risks, especially when treating children. |
to article |
| 2012.05.10 |
PSUR Worksharing Project: Assessment of the active substance Eprosarten and the combination of the active substances Eprosartan and Hydrochlorothiaside A PSUR on eprosartan and the combination of the active substances eprosartan and hydrochlorothiazide is up for evaluation in the PSUR Worksharing Project of the Heads of Medicines Agencies (HMA). The BfArM has taken the role of the P-RMS. Companies interested in participating in the PSUR Worksharing Project for the a.m. substance respectively a.m. combination of active substances are requested to submit a PSUR. |
to article |
| 2012.05.10 |
PSUR Worksharing Project: Evaluation of Mefloquin A PSUR on mefloquin is up for evaluation in the PSUR Worksharing Project of the Heads of Medicines Agencies (HMA). The BfArM will be the P-RMS. Companies concerned with the a.m. substance who wish to take part in the PSUR Worksharing Project, are requested to submit a PSUR. |
to article |
| 2012.05.03 |
Dear Doctor Letter (Rote-Hand-Brief) on Atorvastatin Basics film-coated tablets ® (atorvastatin): Recall of all batches of the medicinal product currently in circulation The maximum daily dose for children (point 3 of the Package Leaflet) is incorrectly stated as "maximum dose of 80 mg once daily" instead of "maximum dose of 20 mg once daily". |
to article |
| 2012.04.30 |
Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): Update on the recommendation for cardiovascular monitoring at the beginning of treatment Important additional recommendations regarding a more intense monitoring of cardiovascular functions at the beginning of treatment with Gilenya® (fingolimod) in patients with relapsing-remitting multiple sclerosis. |
to article |
| 2012.04.19 |
Dear Doctor Letter (Rote-Hand-Brief) on Carbomedac® 10 mg/ml concentrate for solution for infusion (carboplatin): Possible crystallisation of the active substance Due to the danger of a substance-specific crystallisation of the active substance, the solution must be examined for the absence of particles and turbidity prior to use. |
to article |
| 2012.04.12 |
Angiotensin II receptor antagonists (sartans): Suspected potential carcinogenicity risk not confirmed After evaluation of all available data, the suspicion of a slightly increased risk for new cases of cancer in connection with the use of angiotensin II receptor antagonists could not be confirmed. |
to article |
| 2012.04.10 |
Dear Doctor Letter (Rote-Hand-Brief) on Alimta® (pemetrexed): Batch recall Alimta® 500 mg batches recalled due to a possible microbial contamination with Methylobacterium sp. which was discovered during routine controls. In Germany, this concerns batch A931727G and certain imported batches. |
to article |
| 2012.04.05 |
PSUR Worksharing Project: Evaluation of Triptorelin A PSUR on triptorelin is up for evaluation in the PSUR Worksharing Project of the Heads of Medicines Agencies (HMA). The BfArM will be the P-RMS. Companies concerned with the above-mentioned substance who wish to take part in the PSUR Worksharing Project, are requested to submit a PSUR. |
to article |
| 2012.04.04 |
Dear Doctor Letter (Rote-Hand-Brief) on Protelos® (strontium ranelate): New contraindications The pharmaceutical entrepreneur is sending out information on new contraindications and warnings for the use of Protelos® (strontium ranelate). These changes also apply to Osseor®. |
to article |
| 2012.04.04 |
Information letter on Pegasys® (pegylated interferon alfa 2a) pre-filled syringes: Possible shortage Possible shortage of the pharmaceutical form Pegasys® pre-filled syringes and recommendations for healthcare professionals. Prefilled pens are not affected. |
to article |
| 2012.04.04 |
Information letter on Viaspan® (organ preservation solution): Possible contamination of product during the manufacture Since alternative products are licensed in Germany, all potentially contaminated batches of ViaSpan® are recalled in Germany as a precautionary measure. Close medical monitoring after transplantation is recommended for affected patients by way of precaution. |
to article |
| 2012.03.27 |
Dear Doctor Letter (Rote-Hand-Brief) on Perfalgan® 10 mg/ml solution for infusion (paracetamol i.v.): Risk of accidental overdose The pharmaceutical manufacturer again refers to the risk of an accidental overdose of Perfalgan® 10 mg/ml solution for infusion in neonates and infants as well as in underweight adults. |
to article |
| 2012.03.27 |
Dear Doctor Letter (Rote-Hand-Brief) on Samsca® (tolvaptan): Risk of too rapid rise of serum sodium The pharmaceutical manufacturer issues information on the risk of a too rapid rise of serum sodium levels due to the use of Samsca® (tolvaptan) and on how this risk can be reduced. |
to article |
| 2012.03.12 |
Information letter on Vfend® 200 mg powder for solution for infusion (voriconazole): Temporary shortage It is recommended to limit the use of the product to patients without alternative treatment options. An information letter with treatment recommendations has been circulated to treating physicians and pharmacies concerned. |
to article |
| 2012.03.08 |
Information letter on Onglyza® (saxagliptin): Risk of serious hypersensitivity reactions and acute pancreatitis The pharmaceutical manufacturer issues information on important new findings on the use of Onglyza® (saxagliptin) and the related risk of serious hypersensitivity reactions and acute pancreatitis. |
to article |
| 2012.03.05 |
PSUR Worksharing Project: Evaluation of 17a-estradiol A PSUR on 17a-estradiol is up for evaluation in the PSUR Worksharing Project of the Heads of Medicines Agencies (HMA). The BfArM will be the P-RMS. Companies concerned with the above-mentioned substance who wish to take part in the PSUR Worksharing Project, are requested to submit a PSUR. |
to article |
| 2012.03.05 |
PSUR Worksharing Project: Evaluation of Gadobutrol A PSUR on gadobutrol is up for evaluation in the PSUR Worksharing Project of the Heads of Medicines Agencies (HMA). The BfArM will be the P-RMS. Companies concerned with the above-mentioned substance who wish to take part in the PSUR Worksharing Project, are requested to submit a PSUR. |
to article |
| 2012.02.27 |
Dear Doctor Letter (Rote-Hand-Brief) on Rasilez®, Rasilez HCT® and Rasilamlo® (aliskiren): New contraindications and warnings in connection with the use of aliskiren-containing medicines Important information on new contraindications and warnings in connection with the use of aliskiren-containing medicinal products in combination with inhibitors of the angiotensin converting enzyme (ACE inhibitors) or angiotensin receptor blockers (ARB). |
to article |
| 2012.02.24 |
Dear Doctor Letter (Rote-Hand-Brief) on Victrelis (boceprevir): Drug interactions with ritonavir-boosted HIV protease inhibitors In co-ordination with the European Medicines Agency (EMA) the pharmaceutical entrepreneur is circulating information on new findings on drug interactions between boceprevir, a recently licensed oral inhibitor of the hepatitis C virus (HCV)-NS3/4A protease, and ritonavir-boosted HIV protease inhibitors. |
to article |