BfArM - Federal Institute for Drugs and Medical Devices

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819 results

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Fluorouracil,capecitabine, tegafur and flucytosine: recommendation for testing and treatment Date: 04. August 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: fluorouracil | capecitabine | tegafur | flucytosine

The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission with a notice in the national graduated plan procedure.

Methocarbamol/paracetamol-containing medicinal products: benefits continue to outweigh risks Date: 03. August 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: methocarbamol | paracetamol

With regard to the combination drug methocarbamol/paracetamol 380 mg/300 mg, the final decision of the EU Commission was issued on 10.06.2020.

Direct Healthcare Professional Communication (DHPC) on leuprorelin-containing depot drugs: need to strictly follow the instructions regarding preparation and administration to reduce the risk of application errors PDF, 85KB, File is accessible Date: 30. July 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leuprorelin

The marketing authorisation holders of depot medicines containing leuprorelin would like to inform about application errors which could possibly lead to a reduced efficacy.

Yondelis® (trabectedin): review of efficacy due to study discontinuation Date: 24. July 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: trabectedin

EMA has recommended that the use of Yondelis (trabectedin) in treating ovarian cancer remain unchanged following a review of a study that investigated Yondelis as a third-line treatment in patients with ovarian cancer.

Nitrosamines: EMA to provide guidance on avoiding nitrosamines in human medicines Date: 09. July 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: nitrosamine

EMA finalises opinion on presence of nitrosamines in medicines.

Fosfomycin-containing medicinal products: re-evaluation of the risk-benefit ratio according to the current state of scientific knowledge Date: 03. July 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Fosfomycin

The BfArM informs about the initiation of a European risk assessment procedure according to Art. 31 of Directive 2001/83/EC for fosfomycin.

Direct Healthcare Professional Communication (DHPC) on 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: pre-treatment testing to identify DPD-deficient patients PDF, 109KB, File is accessible Date: 04. June 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: 5-fluorouracil, capecitabine, tegafur

The marketing authorisation holders of medicines containing 5-fluorouracil i.v. (5-FU), capecitabine or tegafur, would like to inform you that patients with partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency are at an …

Direct Healthcare Professional Communication (DHPC) on flucytosine: updated recommendations for the use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency PDF, 97KB, File is accessible Date: 04. June 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Flucytosine

Mylan (Meda Pharma GmbH & Co KG) would like to inform you that the treatment with flucytosine is contraindicated in patients with known complete dihydropyrimidine dehydrogenase (DPD) deficiency due to the risk of life-threatening toxicity.

Hydroxychloroquine: renewed warning of risks when used to treat COVID-19 Date: 02. June 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: hydroxychloroquine, chloroquine

The European Medicines Agency (EMA) again warns about the risks of using hydroxychloroquine (and chloroquine) to treat COVID-19.

Direct Healthcare Professional Communication (DHPC) on tolperisone: a reminder of the negative risk-benefit balance if the use is outside the authorised indication PDF, 952KB, File is accessible Date: 02. June 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tolperisone

The marketing authorisation holders of tolperisone containing drugs are once again informing, that since 2013 tolperisone is only authorised for the symptomatic treatment of spasticity after a stroke in adult patients.

Cyproterone-containing medicines: review of meningioma risk Date: 19. May 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: cyproterone

The PRAC recommendations were adopted by the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) by consensus on 25 March 2020.

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.