BfArM - Federal Institute for Drugs and Medical Devices

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818 results

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Hormone replacement therapy: PRAC completes review of new information on known breast cancer risk Date: 15. May 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: substances for hormone replacement therapy

The Committee for Pharmacovigilance Risk Assessment (PRAC) of the EMA recommends updating the current safety information of medicinal products for HRT, in relation to the known increased risk of breast cancer.

Information Letter on Anticholium® (physostigmine salicylate): change in the approval PDF, 158KB, File is accessible Date: 14. May 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: physostigmine salicylate

Dr. Franz Köhler Chemie GmbH informs about the change in the approval of Anticholium®. The intramuscular application is no longer approved. Anticholium® is now sodium metabisulfite free.

Direct Healthcare Professional Communication (DHPC) on brivudine: potentially fatal toxicity of fluoropyrimidines if administered shortly before or at the same time with brivudine or used within 4 weeks after the end of treatment with brivudine PDF, 572KB, File is accessible Date: 12. May 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: brivudine

Marketing authorisation holders of medicines containing brivudine inform that deaths may occur as a result of interaction between brivudine and fluoropyrimidines.

Picato® (ingenol mebutate): evaluation of the benefit-risk ratio Date: 05. May 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ingenol mebutate

The Committee for Medicinal Products for Human Use (CHMP) has adopted the PRAC recommendation.

Hydroxychloroquine: risk of serious side effects when used to treat COVID-19 Date: 29. April 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: hydroxychloroquine, chloroquine

The BfArM informs about the risk of serious side effects when using hydroxychloroquine for the treatment of COVID-19.

Attachment to the application for special approval according to § 11 para. 1 of the Medical Devices Act or Art. 59 of Regulation (EU) 2017/745 in connection with the SARS-CoV-2 pandemic (document in German) PDF, 258KB, File does not meet accessibility standards Date: 27. April 2020 Topics: Pharmakovigilanz Type: Download

Attachment to the application for special approval according to § 11 para. 1 of the Medical Devices Act or Art. 59 of Regulation (EU) 2017/745 in connection with the SARS-CoV-2 pandemic (document in German)

Direct Healthcare Professional Communication (DHPC) on cyproterone acetate: restrictions in use due to the risk of meningioma PDF, 723KB, File is accessible Date: 16. April 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Cyproteronacetat

The marketing authorisation holders of cyproterone containing medicines would like to inform about the occurrence of meningiomas in association with the use of cyproterone acetate.

Information Letter on Zomacton® (somatropin): change in the trade names of the injection equipment for administering the drugs PDF, 192KB, File is accessible Date: 16. April 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: somatropin

Ferring Arzneimittel GmbH informs that the needle-free injection device ZomaJet 2 Vision for the administration of Zomacton® 4 mg has been renamed ZomaJet 4 and the needle-free injection device ZomaJet Vision X for the administration of …

High-dose creams containing estradiol: a new risk review Date: 08. April 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: estradiol

With its notice within the graduated plan procedure of 18 March 2020, the BfArM implements the unanimous decision of the coordination group, CMDh.

Increased ring fractures with vaginal rings Date: 01. April 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: ethinylestradiol/etonogestrel

The BfArM has received a large number of reports of breaks in the vaginal rings GinoRing® (Exeltis Germany GmbH), Cyclelle® (Hexal AG), VeriAristo® (Aristo Pharma GmbH) and Setlona® (Mylan Germany GmbH), which are used for hormonal …