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

819 results

Filter

Results per page: 10 20 30

Sorting:

Latest entries first

Relevance

Latest entries first(selected sorting)

Oldest entries first

Selected filter

Carbomedac®: BfArM's recommendation to filter the medicinal product is cancelled Date: 19. May 2016 Topics: Pharmakovigilanz Type: Risk information

Active substance: Carboplatin

The company Medac Gesellschaft für klinische Spezialpräparate mbH has submitted documents to the BfArM proving that filtering the medicinal product Carbomedac® prior to use as recommended until now by the BfArM is no longer necessary.

Fusafungin (Locabiosol®): increasing number of severe hypersensitivity reactions. Date: 09. May 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Fusafungin

In its notice within the graduated plan procedure the BfArM revoked all marketing authorizations for fusafungin-containing medicinal products in Germany.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing fusafungine (Locabiosol®): revocation of marketing authorisation PDF, 262KB, File is accessible Date: 22. April 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fusafungine

By way of a Dear Doctor Letter, the company concerned is informing healthcare professionals of the revocation of the marketing authorisations of medicinal products containing fusafungine (Locabiosol® as mouth and nose spray) within the EU.

Dear Doctor Letter (Rote-Hand-Brief) on BCR-ABL tyrosine kinase inhibitors: Risk of reactivation of hepatitis B PDF, 339KB, File is accessible Date: 08. April 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: imatinib, dasatinib, nilotinib, bosutinib, ponatinib

The pharmaceutical companies concerned are circulating information on the risk of reactivation of hepatitis B after treatment with BCR-ABL tyrosine kinase inhibitors and the necessity of examining patients with regard to hepatitis B viral load …

Dear Doctor Letter (Rote-Hand-Brief) on Zydelig® (idelalisib): Restrictions of use PDF, 319KB, File is accessible Date: 24. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: idelalisib

The company Gilead Sciences GmbH is circulating information on interim recommendations on restrictions of use of Zydelig.

EMA recommends new safety measures for Zydelig®: close monitoring and use of antibiotics to prevent pneumonia Date: 21. March 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Idelalisib

EMA recommends new safety measures for Zydelig®: close monitoring and use of antibiotics to prevent pneumonia.

Inhalative corticosteroids (ICS) and pneumonia: recommendation by the PRAC Date: 21. March 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: corticosteroids | inhalative

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has now completed its review of this known risk and has confirmed the increased risk of pneumonia.

Dear Doctor Letter (Rote-Hand-Brief) on Zaltrap® (aflibercept): Risk of osteonecrosis of the jaw PDF, 1MB, File does not meet accessibility standards Date: 17. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aflibercept

.

Zydelig® for treatment of chronic lymphocytic leukaemia and follicular lymphoma: initiation of a European safety review Date: 15. March 2016 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: idelalisib

The BfArM issues information on the initiation of a European safety review regarding Zydelig® due to serious adverse events. Zydelig® is authorised in the EU for treatment of two types of rare blood cancers.

Information letter on Xofigo® (Radium-223 dichloride): Change in NIST standard reference material PDF, 167KB, File does not meet accessibility standards Date: 15. March 2016 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium-223 dichloride

The company Bayer Vital GmbH is circulating information that the National Institute of Standards and Technology (NIST) has recently revised the primary standardisation for Radium-223.