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

443 results

Results per page: 10 20 30

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.

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®

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 …