BfArM - Federal Institute for Drugs and Medical Devices

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Combined use of ACE-inhibitors, angiotensin II receptor antagonists or aliskiren: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) within a European safety review Date: 14. June 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ACE-inhibitors | angiotensin II receptor antagonists or aliskiren

The BfArM issues information on the PRAC recommendation within the European safety review according to Article 31 of Directive 2001/83/EC.

Dear Doctor Letter (Rote-Hand-Brief) on cyproterone acetate 2 mg/ethinylestradiol 35 µg PDF, 292KB, File is accessible Date: 12. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cyproterone acetate

Strengthening of warnings, new contraindications and updated indication.

Information Letter on CILEST® and PRAMINO® tablets: Recall of the entire stock from the market PDF, 337KB, File is accessible Date: 04. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ethinyl estradiol, norgestimate

The pharmaceutical manufacturer is sending out information on the recall of the entire stock of CILEST® and PRAMINO® from the market as both products are no longer available.

Dear Doctor Letter (Rote-Hand-Brief) on Samsca® (tolvaptan): liver injury PDF, 188KB, File is accessible Date: 23. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tolvaptan

Information for healthcare professionals regarding the potential risk of liver injury due to Samsca® (tolvaptan).

Information Letter on Nipruss® (sodium nitroprusside): recall all batches PDF, 944KB, File is accessible Date: 23. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium nitroprusside

As a precautionary measure and in co-ordination with the competent supervising authority, the company UCB Pharma GmbH is recalling all batches of Nipruss® dry substance for infusion after reconstitution (PZN 04746699).

Dear Doctor Letter (Rote-Hand-Brief) on Protelos® (strontium ranelate): Restriction of indication PDF, 301KB, File is accessible Date: 13. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: strontium ranelate

Recent data showing an increased risk of myocardial infarction have resulted in restrictions regarding the use of Protelos® (restricted indication, new contraindications and warnings).

Dear Doctor Letter (Rote-Hand-Brief) on Pletal® (cilostazol): New safety information PDF, 3MB, File is accessible Date: 02. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cilostazol

As the result of a review of the benefits and risks of cilostazol and in collaboration with the European Medicines Agency, the indications for medicinal products containing cilostazol have been restricted.

Dear Doctor Letter (Rote-Hand-Brief) on Tavor® pro injectione 2 mg solution for injection (lorazepam): Recall PDF, 119KB, File is accessible Date: 02. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lorazepam

Recall of Tavor® pro injectione 2 mg solution for injection due to possible contamination with glass splinters.

Increlex® 10 mg/ml solution for injection (mecasermin, recombinant human IGF-1): Temporary market shortage PDF, 208KB, File is accessible Date: 30. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mecasermin, recombinant human IGF-1

The company Ipsen Pharma GmbH is sending out information that the medicinal product Increlex® 10 mg/ml solution for injection will presumably be out of stock starting early August 2013. This shortage is due to manufacturing difficulties and …

Information Letter on CAELYX®: As of Monday 29 April 2013, supply with the medicinal product will return to normal PDF, 408KB, File is accessible Date: 23. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

Janssen-Cilag is sending out information that the supply with CAELYX® 2 mg/ml concentrate for solution for infusion is returning to regular availability and that the "CAELYX® Managed Access Programme" is being terminated.