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Dear Doctor Letter (Rote-Hand-Brief) on Ceplene® (0.5 mg/0.5 ml solution for injection): Contamination of the diluent PDF, 71KB, File is accessible Date: 09. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: histamine dihydrochloride

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) advises healthcare professionals to visually inspect the vial prior to administration of Ceplene® in order to exclude particle contamination. The …

Rote-Hand-Brief on Cipralex® PDF, 176KB, File is accessible Date: 05. December 2011 Topics: Pharmakovigilanz Type: Download

Active substance: escitalopram

Dear Doctor Letter (Rote-Hand-Brief) on Cipralex® (escitalopram): Risk of dose-dependent QT interval prolongation and altered recommendations as to the maximum dose in patients older than 65 years PDF, 176KB, File is accessible Date: 05. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: escitalopram

Important information on the risk of dose-dependent prolongations of the QT interval as well as on altered recommendations as to the maximum dose in patients over 65 years of age. These new scientific findings also apply to all generic …

Dear Doctor Letter (Rote-Hand-Brief) on Caelyx® (pegylated liposomal doxorubicin): Supply failure, safety aspects PDF, 119KB, File is accessible Date: 28. November 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

Supply failure of Caelyx® (pegylated liposomal doxorubicin) resulting in a further decline in patient supply.

Rote-Hand-Brief on Caelyx® PDF, 119KB, File is accessible Date: 28. November 2011 Topics: Pharmakovigilanz Type: Download

Active substance: pegylated liposomal doxorubicin

Information letter regarding Apidra® cartridges (insulin glulisine) for injection: Supply of Apidra® PDF, 43KB, File is accessible Date: 24. November 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: insulin glulisine

Updated information on the availability of Apidra® 3 ml cartridges and further steps until full availability has been restored.

GMP shortcomings at Ben Venue Laboratories (BVL), manufacturer of the active substance: Several centrally authorised oncology medicines concerned Date: 24. November 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: busulfan, doxorubicin, bortezomib, azacitidine

Due to considerable shortcomings in adhering to Good Manufacturing Practice (GMP) at the Ben Venue Laboratories in the USA, the manufacturer of the active substance, the Committee for Medicinal Products for Human Use (CHMP) of the European …

EMA recommends suspension of marketing authorisation for all medicinal products containing buflomedil Date: 24. November 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: buflomedil

The Committee for Medicinal Products on Human Use (CHMP) of the European Medicines Agency (EMA) has completed its review of the benefit/risk balance of buflomedil and has come to a negative conclusion. The EMA recommends that all marketing …

Information Letter on Apidra® PDF, 43KB, File is accessible Date: 24. November 2011 Topics: Pharmakovigilanz Type: Download

Active substance: insulin glulisine

Information letter regarding Velcade® 1 mg powder for solution for injection PDF, 228KB, File is accessible Date: 21. November 2011 Topics: Pharmakovigilanz Type: Download

Active substance: bortezomib