BfArM - Federal Institute for Drugs and Medical Devices

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818 results

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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.