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Use of valproate (and related substances) during pregnancy: initiation of a European safety review Date: 15. October 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

At the request of Great Britain, the European Medicines Agency (EMA) has initiated a review procedure in accordance with Article 31 of Directive 2001/83/EC regarding valproate, valproic acid and related substances.

Numeta G 16% E® (nutrient solution for term infants and children up to 2 years of age): Possible risk of hypermagnesemia PDF, 89KB, File is accessible Date: 09. October 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: nutrient solution for term infants and children up to 2 years of age

The company Baxter Deutschland GmbH is sending out information that administration of the medicinal product Numeta G 16% E® to term infants and children up to 2 years of age can possibly lead to the risk of hypermagnesemia.

Dear Doctor Letter (Rote-Hand-Brief) on short-acting beta-agonists/beta 2-sympathomimetic agents (SABAs) for obstetric indications - including Partusisten® (fenoterol): Restrictions of indication PDF, 818KB, File is accessible Date: 01. October 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fenoterol

The company Boehringer Ingelheim communicates important restrictions regarding the use of short-acting beta-agonists/beta 2-sympathomimetic agents (SABAs) for obstetric indications.

Application for changing the legal status Date: 26. September 2013 Topics: Pharmakovigilanz Arzneimittelsicherheit Type: Article

Application for changing the legal status

Dear Doctor Letter (Rote-Hand-Brief) on Lariam® (mefloquine): Risk of neuropsychiatric and other serious adverse reactions as well as inclusion of new contraindications PDF, 2MB, File is accessible Date: 10. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mefloquine

Important information regarding new contraindications (Blackwater fever, severe impairment of liver function) as well as on the risk of neuropsychiatric and other serious adverse reactions under Lariam® (mefloquine) for malaria …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing risperidone or paliperidone: Risk of an intraoperative floppy iris syndrome (IFIS) PDF, 817KB, File is accessible Date: 09. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: risperidone, paliperidone

Important information on the risk of an intraoperative floppy iris syndrome (IFIS) in connection with administration of risperidone or paliperidone to patients undergoing cataract surgery.

Information Letter on the new anticoagulants Eliquis® (apixaban), Pradaxa® (dabigatran etexilate) and Xarelto® (rivaroxaban): Reducing the risk of haemorrhages PDF, 108KB, File is accessible Date: 06. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: apixaban

The marketing authorisation holders request observation of risk factors for haemorrhages as well as of dosage instructions, contraindications, warnings and precautionary measures for use in order to reduce the risk of haemorrhages.

Information Letter on clopidogrel: Risk of acquired haemophilia PDF, 145KB, File is accessible Date: 04. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: clopidogrel

The marketing authorisation holders are circulating information on a small number of cases of acquired haemophilia associated with clopidogrel treatment in patients without a history of haemostasis.

Zyvoxid® 2 mg/ml solution for injection (linezolid): limited supply with immediate effect PDF, 116KB, File is accessible Date: 30. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: linezolid

The company Pfizer Pharma GmbH is circulating information that with immediate effect the medicinal product Zyvoxid® 2 mg/ml solution for injection is available again to a limited extent.

Dear Doctor Letter (Rote-Hand-Brief) on Imnovid® (pomalidomide): Information on important aspects of clinical use PDF, 591KB, File is accessible Date: 28. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pomalidomide

The marketing authorisation holder Celgene is circulating information on important aspects regarding the clinical use of the new medicinal product Imnovid® (pomalidomide).

Dear Doctor Letter (Rote-Hand-Brief) on Neupogen® (filgrastim) and Neulasta® (pegfilgrastim): Risk of capillary leak syndrom PDF, 567KB, File is accessible Date: 26. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: filgrastim

The marketing authorisation holder Amgen GmbH is circulating information on an adverse effect, the capillary leak syndrome (CLS), associated with the treatment of patients with cancer and/or healthy donors with Neupogen® (filgrastim) or Neulasta®

Diane® 35 and generic drugs: risk of thromboembolic events Date: 23. August 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: cyproterone acetate/ethinylestradiol

In a notice dated 8 August 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the European Commission's implementing decision on medicinal products containing the combination cyproterone acetate/ethinylestradiol.

Information Letter on oral ketoconazole-containing medicinal products (Nizoral® tablets): Suspension of marketing authorisation due to serious liver damage
PDF, 75KB, File is accessible
Date: 22. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ketoconazole

After an EU-wide review of the risk of hepatotoxicity under ketoconazole for treatment of fungal infections, the EMA recommends the suspension of the marketing authorisation for Nizoral® tablets (oral ketoconazole-containing medicinal …

Zyvoxid® 2 mg/ml solution for injection (linezolid): Temporary shortage
PDF, 148KB, File is accessible
Date: 15. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: linezolid

The company Pfizer Pharma GmbH is circulating information that the medicinal product Zyvoxid® 2 mg/ml solution for injection can currently not be supplied. This shortage is the result of manufacturing problems of one of the external …

Mucosolvan® Solution for injection (ambroxol hydrochloride)
PDF, 87KB, File is accessible
Date: 09. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ambroxol hydrochloride

Information on mixing with commercially available 5% glucose solution for infusion.

LInformation Letter on Roferon®-A (interferon alfa-2a)
PDF, 2MB, File is accessible
Date: 07. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: interferon alfa-2a

The marketing authorisation holder Roche Pharma is circulating an information letter on a temporary shortage in the supply of Roferon®-A due to relocation of the production site.

Information Letter on PegIntron® (peginterferon alfa-2b)
PDF, 64KB, File is accessible
Date: 02. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: peginterferon alfa-2b

Information on the correct use of the new pre-filled injection pen.

Dear Doctor Letter (Rote-Hand-Brief) on Erivedge® (vismodegib) PDF, 3MB, File is accessible Date: 31. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vismodegib

Important information for safe use, including information on contraceptive programmes.

Information Letter on VOTRIENT® (pazopanib)
PDF, 169KB, File is accessible
Date: 30. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pazopanib

Important change to frequency of serum liver test monitoring for hepatotoxicity.

DepoCyte® 50 mg injectable suspension (liposomal cytarabine for intrathecal injection): Back on the market as of 1 August 2013
PDF, 175KB, File is accessible
Date: 25. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: liposomal cytarabine

As of 1 August 2013, DepoCyte® will be available again regularly on the German market.