BfArM - Federal Institute for Drugs and Medical Devices

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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.

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.

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.

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.

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.

Direct oral anticoagulants (apixaban, dabigatran etexilate, rivaroxaban): no application changes required Date: 30. March 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: apixaban | dabigatran etexilate | rivaroxaban

Following a review of the results of a European study with real-world drug-related data from use, no change in the use criteria of the direct oral anticoagulants Eliquis® (apixaban), Pradaxa® (dabigatran etexilate), and Xarelto® (rivaroxaban) …

Xeljanz® (tofacitinib): increased risk of venous thromboembolic events and of serious and fatal infections Date: 23. March 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: tofacitinib

With the publication of the European Commission's decision, the risk assessment procedure in accordance with Article 20 of Regulation (EC) No. 726/2004 for Xeljanz® was completed.