BfArM - Federal Institute for Drugs and Medical Devices

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819 results

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Dear Doctor Letter (Rote-Hand-Brief) on Rapiscan® (regadenoson): New information regarding the minimisation of the stroke risk and prolongation of Rapiscan-induced seizures after administration of aminophylline PDF, 194KB, File is accessible Date: 22. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: regadenoson

The company Rapidscan Pharma Solutions is circulating new safety information. Postponement of regadenoson administration should be considered in patients with uncontrolled hypertension.

Dear Doctor Letter (Rote-Hand-Brief) on SonoVue® (sulphur hexafluoride): Revised contraindications, warnings and precautions PDF, 589KB, File is accessible Date: 18. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sulphur hexafluoride

The company Bracco Imaging Deutschland GmbH is circulating information on rare but severe arrhythmias, sometimes fatal, in patients with cardiovascular instability during stress echocardiography procedures with SonoVue® used in combination …

Dear Doctor Letter (Rote-Hand-Brief) on CellCept® (mycophenolate mofetil): New warnings with regard to the risk of hypogammaglobulinaemia and bronchiectasis PDF, 2MB, File is accessible Date: 17. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mycophenolate mofetil

The company Roche Pharma AG is circulating new safety information regarding the risk of hypogammaglobulinaemia and bronchiectasis for all products that release mycophenolic acid as the active metabolite.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing valproate (and related substances): Risks for the unborn child in case of exposure during pregnancy Date: 12. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: valproat, related substances

Important new information and increased safety warnings with regard to medicinal products containing valproate and related substances (sodium valproate, valproic acid, valproate semisodium and valpromide).

Dear Doctor Letter (Rote-Hand-Brief) on Procoralan® (ivabradine): New contraindication and recommendations for minimisation of risks of cardiovascular events and severe bradycardias PDF, 1MB, File is accessible Date: 11. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ivabradine

The company Servier Deutschland GmbH is circulating information that concomitant use of ivabradine with verapamil or diltiazem is now contraindicated.

Marketing authorisations based on studies conducted by GVK Biosciences in India: suspension of marketing authorisation Date: 09. December 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

In a notice dated 8 December 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the suspension of several marketing authorisations that were based on a clinical trial conducted by GVK Biosciences in India.

Dear Doctor Letter (Rote-Hand-Brief) on Tecfidera® (dimethyl fumarate): Suspected case of progressive multifocal leukoencephalopathy (PML) PDF, 195KB, File is accessible Date: 04. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethyl fumarate

The company Biogen Idec GmbH is circulating information on a fatal case of progressive multifocal leukoencephalopathy (PML) in a patient with a severe and long-term lymphopenia treated with Tecfidera®.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing bromocriptine: Restrictions of indication regarding inhibition of lactation PDF, 1MB, File is accessible Date: 04. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bromocriptine

The marketing authorisation holders of medicinal products containing bromocriptine are circulating information that bromocriptine should only be taken in strengths up to 2.5 mg per individual dose for prevention or inhibition of lactation …

Information on medicinal products affecting the renin-angiotensin system: Key elements for communication PDF, 42KB, File is accessible Date: 01. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ACE-Hemmer, Angiotensin-II-Rezeptor-Antagonisten, Aliskiren

The Pharmacovigilance Risk Assessment Committee (PRAC) has adopted key elements regarding communication of the outcome of the safety review regarding medicinal products that affect the renin-angiotensin system.

Oral bromocriptine-containing medicines: indicated in the prevention or suppression of physiological lactation post-partum Date: 28. November 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: bromocriptine

In its notice of 27 November 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission of 30 October 2014 regarding medicinal products containing …