BfArM - Federal Institute for Drugs and Medical Devices

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Rote-Hand-Brief on Cardioxane® PDF, 279KB, File is accessible Date: 18. July 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dexrazoxane

Dear Doctor Letter (Rote-Hand-Brief) on Cardioxane® (dexrazoxane): Restricted indications PDF, 279KB, File is accessible Date: 18. July 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexrazoxane

As part of an arbitration by the EMA in 2017, the contraindications for children and adolescents listed in this dear Doctor Letter were partially removed.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing pioglitazone (actos®, Competact®, Tandemact®): Increased incidence of bladder cancer PDF, 178KB, File is accessible Date: 10. June 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pioglitazone

Important safety information on the use of medicinal products containing pioglitazone.

Information Letter regarding Regranex® Gel (becaplermin): Discontinuation of distribution in Europe PDF, 336KB, File is accessible Date: 10. June 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: becaplermin

According to information from the pharmaceutical manufacturer, the distribution of Regranex® Gel (becaplermin 0.01%) in Europe will be discontinued as of 30 June.

Rote-Hand-Brief on actos®, Competact® and Tandemact® PDF, 178KB, File is accessible Date: 10. June 2011 Topics: Pharmakovigilanz Type: Download

Active substance: pioglitazon

Information Letter on Regranex® PDF, 336KB, File is accessible Date: 10. June 2011 Topics: Pharmakovigilanz Type: Download

Active substance: becaplermin

Oral contraceptives containing drospirenone (e.g. Yasmin®) - Update of product information regarding the risk of venous thromboembolisms Date: 30. May 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: drospirenone

Epidemiological studies have shown that the risk of venous thromboembolic events (VTE) due to the use of combined oral contraceptives (COCs) containing drospirenone is greater than when taking COCs containing levonorgestrel (so-called second …

Oral administration of medicinal products containing buflomedil: EMA recommends suspension of marketing authorisation Date: 26. May 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: buflomedil

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended suspending the marketing authorisation for oral use of medicines containing buflomedil in EU Member States.

Information Letter on Anemet® 200 mg Tabletten PDF, 143KB, File is accessible Date: 26. April 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dolasetrone

Information letter regarding Anemet® 200 mg tablets (dolasetron): Discontinuation of production PDF, 143KB, File is accessible Date: 26. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dolasetron

Due to the risk of arrhythmias in connection with the administration of Anemet® 200 mg tablets to adults for prevention and treatment of nausea and vomiting associated with cytostatic chemotherapy, the pharmaceutical manufacturer has renounced …

Rote-Hand-Brief on Thalidomide Celgene™ PDF, 129KB, File is accessible Date: 21. April 2011 Topics: Pharmakovigilanz Type: Download

Active Substance: thalidomide

(Extract from the Summary of Product Characteristics)

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene™ (thalidomide): Occurrence of thromboembolic events PDF, 129KB, File is accessible Date: 21. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thalidomide

Important information on the occurrence of thromboembolic events associated with Thalidomide Celgene™ (thalidomide).

Information Letter on Thyrogen® PDF, 59KB, File is accessible Date: 11. April 2011 Topics: Pharmakovigilanz Type: Download

Active substance: thyrotropin alfa

Information letter on Thyrogen® (thyrotropin alfa): Supply shortage due to a manufacturing issue and temporary treatment recommendations from the EMA PDF, 59KB, File is accessible Date: 11. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thyrotropin alfa

An information letter on the treatment recommendations has been sent to attending physicians and pharmacies concerned.

Information Letter on Onsenal® PDF, 2MB, File is accessible Date: 08. April 2011 Topics: Pharmakovigilanz Type: Download

Active substance: celecoxibe

Information letter on Onsenal® (celecoxibe): Company-led drug withdrawal for the indication "familial adenomatous polyposis" (FAP) PDF, 2MB, File is accessible Date: 08. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: celecoxibe

Important information on the company-led drug withdrawal of Onsenal® (celecoxibe) for the indication familial adenomatous polyposis.

EMA announcement on possible radioactivity of medicinal products manufactured in Japan Date: 05. April 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance:

The BfArM calls attention to the public announcement made by the European Medicines Agency (EMA) in co-ordination with the European licensing authorities following the radiation leak from the Fukushima Daiichi nuclear power plant in Japan.

Rote-Hand-Brief on Revlimid® PDF, 389KB, File is accessible Date: 01. April 2011 Topics: Pharmakovigilanz Type: Download

Active substance: lenalidomide

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Potential risk of second primary tumours PDF, 389KB, File is accessible Date: 01. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

Important information on the potential risk of second primary tumours in patients treated with Revlimid® (lenalidomide).

Topiramate: Data concerning the risk of malformations Date: 22. March 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: topiramate

Based on evaluations from pregnancy registries, the USA has now also revised the product informations of medicinal products containing topiramate and has included corresponding warnings already implemented in European marketing authorisations.

Dear Doctor Letter (Rote-Hand-Brief) on TYGACIL® (tigecycline): Restrictions in all indications PDF, 44KB, File is accessible Date: 17. March 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tigecycline

Important information on restrictions in all indications of TYGACIL® (tigecycline) due to increased mortality observed in clinical trials.

Rote-Hand-Brief on Tygacil® PDF, 44KB, File is accessible Date: 17. March 2011 Topics: Pharmakovigilanz Type: Download

Active substance: tigecycline

Rote-Hand-Brief on Zerit® PDF, 419KB, File is accessible Date: 09. March 2011 Topics: Pharmakovigilanz Type: Download

Active substance: stavudine

Dear Doctor Letter (Rote-Hand-Brief) on ZERIT® (stavudine): Restricted indications PDF, 419KB, File is accessible Date: 09. March 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: stavudine

Important information on restrictions in the indications of ZERIT® (stavudine) due to potentially serious adverse reactions.

Dear Doctor Letter (Rote-Hand-Brief) on Anemet 100 mg i.v.® (dolasetron): Renunciation of marketing authorisation PDF, 90KB, File is accessible Date: 18. February 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dolasetron

Due to the risk of arrhythmias in connection with the intravenous administration of dolasetron to adults for treatment of nausea and vomiting associated with cytostatic chemotherapy, the pharmaceutical manufacturer has renounced this marketing …

Dear Doctor Letter (Rote-Hand-Brief) on Vigil® (modafinil): Restricted indication and important safety information PDF, 104KB, File is accessible Date: 11. February 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: modafinil

A safety review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has lead to a restriction of the indications of Vigil® (modafinil) to adults with excessive sleepiness associated with …

Rote-Hand-Brief on Anemet® PDF, 90KB, File is accessible Date: 10. February 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dolasetrone

Rote-Hand-Brief on Vigil® PDF, 104KB, File is accessible Date: 07. February 2011 Topics: Pharmakovigilanz Type: Download

Active substance: modafinil

Dexrazoxane: Referral procedure for clarification of a potentially increased risk of secondary cancers Date: 28. January 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: dexrazoxane

In the course of a graduated plan procedure, stage II, the BfArM announces the initiation of a referral procedure in accordance with Article 31 of Directive 2001/83/EC.

Dear Doctor Letter (Rote-Hand-Brief) on Octenisept® (octenidine hydrochloride, phenoxyethanol): Swelling and tissue damage following irrigation under pressure PDF, 2MB, File is accessible Date: 27. January 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: octenidine hydrochloride, phenoxyethanol

Warning against incorrect use of Octenisept®.