BfArM - Federal Institute for Drugs and Medical Devices

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107 results

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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.

Calcitonin: restricted use Date: 19. March 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Calcitonin

With regard to the intranasal route of administration for the osteoporosis indication, suspension of the marketing authorisations has been extended until 1 April 2020.

Medicinal products containing kava-kava: risk of severe hepatic injury, alterations of the marketing authorisations concerned Date: 23. December 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: kava-kava

The Cologne Administrative Court issues a ruling regarding the legality of the decision in the national graduated plan procedure ("Stufenplanverfahren").

Methotrexate: dosing errors Date: 25. November 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: methotrexate

The Federal Institute for Drugs and Medical Devices (BfArM) is implementing the corresponding implementing decision of the European Commission C(2019) 7680 final of 21 October 2019 by decision of 20 November 2019.

Sibutramine containing medicines: implementation of European Commission decision to suspend marketing authorisation due to increased risk of cardiovascular events Date: 04. October 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: sibutramine

On 30 September 2010, the Federal Institute for Drugs and Medical Devices (BfArM) ordered the implementation of the European Commission's decision on drugs containing sibutramine and the increased risk of cardiovascular events. In a letter …

Omega-3 fatty acids: EMA reviewing use after heart attacks Date: 18. June 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: omega-3 fatty acids

The Federal Institute for Drugs and Medical Devices (BfArM) is implementing the implementing decision of the European Commission in its notification of 14 June 2019.

Fenspiride-containing drugs: potential risk of cardiac arrhythmia Date: 06. June 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: fenspirid

The PRAC recommendation was adopted by the CMDh by consensus and will be implemented directly at national level.

Fluoroquinolones: severe and long-lasting side effects in muscles, joints and nervous system Date: 02. May 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: fluoroquinolones | quinolones

In response to enquiries, the BfArM refers at this point to Annex II of the Commission Decision, which describes areas of application in Category 1.

Metamizole: inconsistent information regarding dosage and contraindications Date: 04. April 2019 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Metamizol

The European Medicines Agency (EMA) has started a review of medicines containing metamizole.