BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Search i

Search help

  • Enter one or more search terms in the search field. Upper and lower case are not relevant.
  • As soon as you have entered three letters in the search field, various search words will be suggested from which you can choose one.
  • If you are searching for a certain group of words, put these words in double quotes. The hits will then contain the words in the order you entered, e.g. "medicines for children".
  • Multiple search terms can also be combined with the Boolean operators AND and OR. When using the operator AND, the results contain the intersection of all search terms. When using the operator OR, the hits contain one of the search terms or only individual search terms. The result set is therefore significantly larger. Please note that these operators must be written in capital letters.
  • If you receive a (too) large number of hits as a result of your search, you can narrow it down by using filters. These filter options appear to the left of the search results and are subdivided into:

    • category (e.g. safety of medicinal products, medical devices, code systems)
    • format (e.g. download, risk information, DHPCs)
    • time interval (e.g. last 30 days, older than ...)
  • Selected filters can be removed individually or all at once ("Show all results").
  • By default, search results are sorted by relevance, but they can also be sorted chronologically ("Latest entries first" or "Oldest entries first").

Enter search term

448 results

Results per page: 10 20 30

Selected filter

Information Letter on Pegasys® (pegylated interferon alfa 2a) pre-filled syringes: Possible shortage PDF, 800KB, File is accessible Date: 04. April 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated interferon alfa 2a

Possible shortage of the pharmaceutical form Pegasys® pre-filled syringes and recommendations for healthcare professionals. Prefilled pens are not affected.

Information Letter on Viaspan® (organ preservation solution): Possible contamination of product during the manufacture PDF, 113KB, File is accessible Date: 04. April 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: organ preservation solution

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 …

Dear Doctor Letter (Rote-Hand-Brief) on Perfalgan® 10 mg/ml solution for infusion (paracetamol i.v.): Risk of accidental overdosage PDF, 387KB, File is accessible Date: 27. March 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: paracetamol i.v.

The pharmaceutical manufacturer again refers to the risk of an accidental overdosage of Perfalgan® 10 mg/ml solution for infusion in neonates and infants as well as in underweight adults.

Dear Doctor Letter (Rote-Hand-Brief) on Samsca® (tolvaptan): Risk of too rapid rise of serum sodium PDF, 585KB, File is accessible Date: 27. March 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tolvaptan

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.

Information Letter on Vfend® 200 mg powder for solution for infusion (voriconazole): Temporary shortage PDF, 47KB, File is accessible Date: 12. March 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: voriconazole

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.

Information Letter on Onglyza® (saxagliptin): Risk of serious hypersensitivity reactions and acute pancreatitis PDF, 183KB, File is accessible Date: 08. March 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: saxagliptin

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.

Information Letter on Halaven® (eribulin): Danger of dosing errors PDF, 58KB, File is accessible Date: 05. March 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: eribulin

Danger of dosing errors due to the fact that the dose is stated differently in the EU compared to several other regions and in some publications.

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 PDF, 87KB, File is accessible Date: 27. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aliskiren

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 …

Dear Doctor Letter (Rote-Hand-Brief) on Victrelis (boceprevir): Drug interactions with ritonavir-boosted HIV protease inhibitors PDF, 100KB, File is accessible Date: 24. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: boceprevir

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 …

Information Letter on Mircera® (methoxy polyethylene glycol-epoetin beta): Impending supply failure, note on switching to alternative treatments PDF, 1MB, File is accessible Date: 02. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methoxy polyethylene glycol-epoetin beta

An information letter with treatment recommendations has been circulated to treating physicians and pharmacies concerned.

Information Letter on Mircera® (methoxy polyethylene glycol-epoetin beta): Possible shortages: Note on switching to alternative treatments PDF, 886KB, File is accessible Date: 02. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methoxy polyethylene glycol-epoetin beta

An information letter with treatment recommendations has been circulated to treating physicians and pharmacies concerned.

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): Increased cardiovascular monitoring at the beginning of treatment PDF, 638KB, File is accessible Date: 27. January 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

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.

Dear Doctor Letter (Rote-Hand-Brief) on Velcade® (bortezomib): Intravenous injection is the only correct route of administration PDF, 127KB, File is accessible Date: 16. January 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bortezomib

The only licensed route of administration of Velcade® (1 mg, 3.5 mg, powder for solution for injection) is via intravenous injection. Velcade® must not be administered in any other manner.

Dear Doctor Letter (Rote-Hand-Brief) on Rasilez®, Rasilez HCT® and Rasilamlo® (aliskiren): Potential risks of cardiovascular or renal adverse events PDF, 72KB, File is accessible Date: 05. January 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aliskiren

Important information on potential risks of cardiovascular or renal adverse events in patients with type 2 diabetes and renal impairment and/or cardiovascular diseases who are being treated with medicinal products containing aliskiren.

Dear Doctor Letter (Rote-Hand-Brief) on UVADEX™: Visual inspection of vials prior to administration PDF, 57KB, File is accessible Date: 29. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance:

Therakos Europe advises healthcare professionals to visually inspect the UVADEX™ vials prior to administration in order to exclude particle contamination. Furthermore, suspected cases of sepsis should be reported along with the numbers of the …

Dear Doctor Letter (Rote-Hand-Brief) on Hexvix®: Visual inspection of vials prior to administration PDF, 668KB, File is accessible Date: 29. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hexaminolevulinate hydrochloride

Ipsen Pharma GmbH advises healthcare professionals to visually inspect the Hexvix® vials prior to administration in order to exclude particle contamination. Furthermore, suspected cases of sepsis should be reported along with the numbers of …

Dear Doctor Letter (Rote-Hand-Brief) on Virazole® (ribavirin) 6 g dry substance, powder to be reconstituted for aerosol administration: Problems with sterility and particle contamination at the manufacturing site PDF, 104KB, File is accessible Date: 23. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ribavirin

MEDA Pharma recommends only treating patients with Virazole® if its use is considered to be absolutely essential.

Dear Doctor Letter (Rote-Hand-Brief) on Strattera® (atomoxetine): Risk of increased blood pressure and/or heart rate PDF, 286KB, File is accessible Date: 13. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: atomoxetine

Important safety-relevant information on the risk of increased blood pressure and/or heart rate associated with the use of Strattera® (atomoxetine) for treatment of Attention Deficit/Hyperactivity Disorder (ADHD).

Dear Doctor Letter (Rote-Hand-Brief) on Torisel® (temsirolimus, concentrate and diluent for solution for infusion): Contamination of the diluent PDF, 576KB, File is accessible Date: 09. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: temsirolimus

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) advises healthcare professionals to visually inspect the diluent prior to administration of Torisel® in order to exclude particle contamination. …

Dear Doctor Letter (Rote-Hand-Brief) on Ceplene® (0.5 mg/0.5 ml solution for injection): Contamination of the diluent PDF, 71KB, File is accessible Date: 09. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: histamine dihydrochloride

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) advises healthcare professionals to visually inspect the vial prior to administration of Ceplene® in order to exclude particle contamination. The …