BfArM - Federal Institute for Drugs and Medical Devices

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818 results

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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.

BfArM issues warning against use of Ukrain Date: 22. December 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance:

According to information available to the BfArM, large amounts of the medicinal product "Ukrain" are still being marketed illegally in Germany and other EU Member States.

Medicinal products containing somatropin: EMA confirms positive benefit/risk balance. Prescribers are reminded to adhere strictly to authorised indications and dosage recommendations Date: 19. December 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: somatropin

In the course of the risk assessment procedure for medicinal products containing somatropin, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a recommendation confirming that the …

Rote-Hand-Brief on Strattera® PDF, 286KB, File is accessible Date: 13. December 2011 Topics: Pharmakovigilanz Type: Download

Active substance: atomoxetine

Additional information (available in German only):

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).

Rote-Hand-Brief on Ceplene® PDF, 71KB, File is accessible Date: 09. December 2011 Topics: Pharmakovigilanz Type: Download

active substance: histamine dihydrochloride

Rote-Hand-Brief on Torisel® PDF, 576KB, File is accessible Date: 09. December 2011 Topics: Pharmakovigilanz Type: Download

Active substance: temsirolimus

Final SmPC and PL wording agreed by PhVWP in September 2011 PDF, 14KB, File is accessible Date: 09. December 2011 Topics: Pharmakovigilanz Type: Download

Von der Pharmakovigilance Working Party verabschiedete Texte der Fach- und Gebrauchsinformation

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 …

Rote-Hand-Brief on Cipralex® PDF, 176KB, File is accessible Date: 05. December 2011 Topics: Pharmakovigilanz Type: Download

Active substance: escitalopram

Dear Doctor Letter (Rote-Hand-Brief) on Cipralex® (escitalopram): Risk of dose-dependent QT interval prolongation and altered recommendations as to the maximum dose in patients older than 65 years PDF, 176KB, File is accessible Date: 05. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: escitalopram

Important information on the risk of dose-dependent prolongations of the QT interval as well as on altered recommendations as to the maximum dose in patients over 65 years of age. These new scientific findings also apply to all generic …

Dear Doctor Letter (Rote-Hand-Brief) on Caelyx® (pegylated liposomal doxorubicin): Supply failure, safety aspects PDF, 119KB, File is accessible Date: 28. November 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

Supply failure of Caelyx® (pegylated liposomal doxorubicin) resulting in a further decline in patient supply.

Rote-Hand-Brief on Caelyx® PDF, 119KB, File is accessible Date: 28. November 2011 Topics: Pharmakovigilanz Type: Download

Active substance: pegylated liposomal doxorubicin

Information letter regarding Apidra® cartridges (insulin glulisine) for injection: Supply of Apidra® PDF, 43KB, File is accessible Date: 24. November 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: insulin glulisine

Updated information on the availability of Apidra® 3 ml cartridges and further steps until full availability has been restored.

GMP shortcomings at Ben Venue Laboratories (BVL), manufacturer of the active substance: Several centrally authorised oncology medicines concerned Date: 24. November 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: busulfan, doxorubicin, bortezomib, azacitidine

Due to considerable shortcomings in adhering to Good Manufacturing Practice (GMP) at the Ben Venue Laboratories in the USA, the manufacturer of the active substance, the Committee for Medicinal Products for Human Use (CHMP) of the European …

EMA recommends suspension of marketing authorisation for all medicinal products containing buflomedil Date: 24. November 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: buflomedil

The Committee for Medicinal Products on Human Use (CHMP) of the European Medicines Agency (EMA) has completed its review of the benefit/risk balance of buflomedil and has come to a negative conclusion. The EMA recommends that all marketing …

Information Letter on Apidra® PDF, 43KB, File is accessible Date: 24. November 2011 Topics: Pharmakovigilanz Type: Download

Active substance: insulin glulisine

Information letter regarding Velcade® 1 mg powder for solution for injection PDF, 228KB, File is accessible Date: 21. November 2011 Topics: Pharmakovigilanz Type: Download

Active substance: bortezomib

Information Letter on Velcade® 1 mg powder for solution for injection (bortezomib) : Discontinuation of supply due to production difficulties PDF, 97KB, File is accessible Date: 21. November 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bortezomib

The pharmaceutical manufacturer issues information on the discontinuation of supply of Velcade® 1 mg powder for solution for injection due to production difficulties on the part of the contract manufacturer.

Rote-Hand-Brief on Supertendin® PDF, 199KB, File is accessible Date: 17. November 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dexamethasone

Dear Doctor Letter (Rote-Hand-Brief) on Supertendin® 5 ampoules: Batch recall due to a quality defect PDF, 199KB, File is accessible Date: 17. November 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexamethasone

The pharmaceutical manufacturer issues new information on the pharmacy and physician level recall of certain batches of Supertendin® 5 ampoules based on a quality defect.

Rote-Hand-Brief on Cipramil® PDF, 147KB, File is accessible Date: 31. October 2011 Topics: Pharmakovigilanz Type: Download

Active substance: citalopram

Dear Doctor Letter (Rote-Hand-Brief) on Cipramil® (citalopram): Risk of dose-dependent QT interval prolongation PDF, 147KB, File is accessible Date: 31. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: citalopram

Important information on the risk of dose-dependent prolongations of the QT interval as well as on altered recommendations as to the maximum dose.

These new scientific findings also apply to all generic marketing authorisations of …

Rote-Hand-Brief on Supertendin® PDF, 237KB, File is accessible Date: 27. October 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dexamethasone

Rote-Hand-Brief on Pradaxa® PDF, 428KB, File is accessible Date: 27. October 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dabigatran etexilate

Dear Doctor Letter (Rote-Hand-Brief) on Pradaxa® (dabigatran etexilate): Necessity of monitoring renal function PDF, 428KB, File is accessible Date: 27. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dabigatran etexilate

Summaries of Product Characteristics and reference material for physicians extended to include information on the necessity of determining the creatinine clearance prior to beginning treatment as well as of further control of renal function.

Dear Doctor Letter (Rote-Hand-Brief) on Supertendin® 5 ampoules: Batch recall due to a quality defect PDF, 237KB, File is accessible Date: 27. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexamethasone

The pharmaceutical manufacturer issues information on the pharmacy and physician level recall of certain batches of Supertendin® 5 ampoules based on a quality defect.

Rote-Hand-Brief on Advagraf® PDF, 299KB, File is accessible Date: 21. October 2011 Topics: Pharmakovigilanz Type: Download

active substance: tacrolimus

Rote-Hand-Brief on Refludan® PDF, 347KB, File is accessible Date: 21. October 2011 Topics: Pharmakovigilanz Type: Download

Active substance: lepirudin