BfArM - Federal Institute for Drugs and Medical Devices

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819 results

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Medicinal products containing dimethyl fumarate (Tecfidera®, Fumaderm®) and progressive multifocal leukoencephalopathy (PML): Conclusion of the variation worksharing Date: 26. October 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: Dimethylfumarat

The BfArM issues information that the variation worksharing procedure regarding progressive multifocal leukoencephalopathy in connection with the use of medicinal products containing dimethyl fumarate has been concluded.

Information letter on Zelboraf®: Potentiation of radiation damage PDF, 105KB, File is accessible Date: 20. October 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vemurafenib

The company Roche Pharma AG is circulating information, that cases of severe radiation damage have been reported in patients treated with radiation prior to, during or subsequent to treatment with Zelboraf.

Codeine: review of the risk-benefit ratio of codeine-containing drugs for the treatment of cough in children and adolescents Date: 16. October 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: codeine

Treatment of cough in children younger than 12 years with medicinal products containing codeine is no longer permitted due to the risk of respiratory depression.

Educational material: Hearing of parallel importers pursuant to the graduated plan ("Stufenplan") Date: 13. October 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: different

Parallel importers are requested to comment in a hearing pursuant to the graduated plan.

Information Letter on Reminyl®: Serious skin reactions; Stevens-Johnson Syndrome and acute generalised exanthematous pustulosis PDF, 377KB, File is accessible Date: 22. September 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Galantaminhydrobromid

The company Janssen-Cilag is circulating information on a new warning for Reminyl®.

Dear Doctor Letter (Rote-Hand-Brief) on Betmiga® (mirabegron): New recommendations concerning the risk of increased blood pressure PDF, 413KB, File is accessible Date: 07. September 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mirabegron

The company Astellas Pharma GmbH is circulating information that serious cases of hypertension and increased blood pressure have been reported under treatment with mirabegron.

Fumaderm: progressive multifocal leukoencephalopathy (PML), hearing within a graduated plan procedure ("Stufenplanverfahren"), stage II Date: 04. September 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: Fumarsäureester

After receiving reports of adverse reactions of currently nine cases of progressive multifocal leukoencephalopathy (PML) in connection with the use of Fumaderm®, the BfArM considers amendments of the section on adverse events in the product …

Olysio® (simeprevir) in combination with Sovaldi® (sofosbuvir): Risk of severe arrhythmias if used concomitantly with amiodarone Date: 21. August 2015 Topics: Pharmakovigilanz Type: Risk information

Active substance: simeprevir, sofosbuvir

In accordance with the evaluation of cardiac safety of the concomitant administration of Harvoni®, Daklinza® and Sovaldi® with amiodarone, the Pharmacovigilance Risk Assessment Committee (PRAC) has also revised the medicinal product Olysio® …

Dear Doctor Letter (Rote-Hand-Brief) on InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix: Possible temporary shortage of the medicinal product PDF, 77KB, File is accessible Date: 13. August 2015 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dibotermin alfa

The company Medtronic BioPharma B.V. is circulating information that InductOs is expected to run out of stock as of the end of October 2015.

Ibuprofen-containing medicines: cardiovascular risk Date: 27. July 2015 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ibuprofen

In its notice of 22 July 2015, the BfArM has ruled the realisation of the decision of the Co-ordination group for Mutual Recognition and Decentralised Procedures - Human (CMDh) of 20 May 2015 regarding medicinal products containing …