BfArM - Federal Institute for Drugs and Medical Devices

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819 results

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Medicinal product Corlentor®/Procoralan® (ivabradine): Initiation of a European safety review Date: 27. June 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ivabradine

The BfArM issues information on the initiation of a European safety review according to Article 20 of Regulation (EC) No. 726/2004 regarding Corlentor®/Procoralan® (ivabradine)

Dantrolene sodium (DANTROLEN i.v.®): Use of filter needles to draw up reconstituted solution from new stock until further notice PDF, 1MB, File is accessible Date: 27. June 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dantrolene sodium

The company Norgine GmbH is circulating information that some vials of dantrolene sodium for intravenous use after reconstitution may contain visible particles of the active substance.

Sutent® 25 mg and 50 mg hard capsules: BfArM issues warning regarding counterfeits of the medicinal product from Romania Date: 17. June 2014 Topics: Pharmakovigilanz Type: Risk information

Active substance: sunitinib

The Federal Institute for Medicinal Products and Medical Devices (BfArM) is circulating a warning against counterfeits of the 25 mg and 50 mg strengths of the cancer drug Sutent® produced by Pfizer. The counterfeits that are parallel imported …

Dear Doctor Letter (Rote-Hand-Brief) on transdermal patches containing fentanyl: Possible life-threatening consequences of accidental exposure PDF, 1MB, File is accessible Date: 13. June 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fentanyl

The marketing authorisation holders are circulating information on possible life-threatening consequences of accidental exposure to patches containing fentanyl.

Information Letter on Procoralan®: Potentially dangerous bradycardia PDF, 1MB, File is accessible Date: 11. June 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ivabradine

The company Servier Deutschland GmbH has issued a reminder that specific conditions for use must be observed in order to avoid potentially dangerous bradycardia when administering the medicinal product Procoralan® containing ivabradine for …

Rienso® (ferumoxytol): Risk of serious hypersensitivity reactions Date: 05. June 2014 Topics: Pharmakovigilanz Type: Risk information

Active substance: ferumoxytol

The EMA is in the process of evaluating all worldwide data available on serious hypersensitivity reactions in connection with administration of the medicinal product Rienso (ferumoxytol) which, however, is currently not being marketed in …

Dear Doctor Letter (Rote-Hand-Brief) on Invirase® (saquinavir): Important new safety information on ECG monitoring PDF, 467KB, File is accessible Date: 28. May 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: saquinavir

The company Roche Pharma AG is circulating information on new recommendations regarding ECG monitoring in treatment-naïve patients receiving Invirase® (saquinavir). This Dear Doctor Letter is intended to emphasise the necessity of ECG

Dear Doctor Letter (Rote-Hand-Brief) on Norditropin® SimpleXx® 10 mg/1.5 ml: Counterfeit PDF, 2MB, File is accessible Date: 23. May 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: somatropin

The company Novo Nordisk Pharma GmbH is circulating information on the discovery of a counterfeit cartridge of the medicinal product Norditropin® SimpleXx® 10 mg/1.5 ml (active substance: somatropin).

Strontium ranelate containing medicinal products: risk of cardiavascular side effects Date: 19. May 2014 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: strontium ranelate

The BfArM issues information on the implementing decision of the Commission within a European safety review in accordance with Article 20 of Regulation (EC-European Community) No. 726/2004.

Information Letter on Buccolam®: Recall due to a potential quality defect PDF, 300KB, File is accessible Date: 09. May 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: midazolam

The company ViroPharma GmbH issues information on the recall of the medicinal product Buccolam®. During a routine inspection at the manufacturing site, the potential risk of a cross-contamination with another medicinal product produced at the …