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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.

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.

Information Letter on Velcade® 1 mg powder for solution for injection (bortezomib) : Discontinuation of supply due to production difficulties PDF, 97KB, File is accessible Date: 21. November 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bortezomib

The pharmaceutical manufacturer issues information on the discontinuation of supply of Velcade® 1 mg powder for solution for injection due to production difficulties on the part of the contract manufacturer.

Dear Doctor Letter (Rote-Hand-Brief) on Supertendin® 5 ampoules: Batch recall due to a quality defect PDF, 199KB, File is accessible Date: 17. November 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexamethasone

The pharmaceutical manufacturer issues new information on the pharmacy and physician level recall of certain batches of Supertendin® 5 ampoules based on a quality defect.

Dear Doctor Letter (Rote-Hand-Brief) on Cipramil® (citalopram): Risk of dose-dependent QT interval prolongation PDF, 147KB, File is accessible Date: 31. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: citalopram

Important information on the risk of dose-dependent prolongations of the QT interval as well as on altered recommendations as to the maximum dose.

These new scientific findings also apply to all generic marketing authorisations of …

Dear Doctor Letter (Rote-Hand-Brief) on Pradaxa® (dabigatran etexilate): Necessity of monitoring renal function PDF, 428KB, File is accessible Date: 27. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dabigatran etexilate

Summaries of Product Characteristics and reference material for physicians extended to include information on the necessity of determining the creatinine clearance prior to beginning treatment as well as of further control of renal function.

Dear Doctor Letter (Rote-Hand-Brief) on Supertendin® 5 ampoules: Batch recall due to a quality defect PDF, 237KB, File is accessible Date: 27. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexamethasone

The pharmaceutical manufacturer issues information on the pharmacy and physician level recall of certain batches of Supertendin® 5 ampoules based on a quality defect.

Dear Doctor Letter (Rote-Hand-Brief) on Advagraf® 0.5 mg hard capsules (tacrolimus): Risk of increased blood levels of tacrolimus due to use of particular batches PDF, 299KB, File is accessible Date: 21. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tacrolimus

The pharmaceutical manufacturer issues information on the fact that there is a risk of higher levels of tacrolimus in the blood of patients taking Advagraf® 0.5 mg hard capsules due to quality defects detected in particular batches. The …

Dear Doctor Letter (Rote-Hand-Brief) on Refludan® (lepirudin): Permanent discontinuation of the distribution of Refludan® PDF, 347KB, File is accessible Date: 21. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lepirudin

The pharmaceutical manufacturer issues information on the planned permanent discontinuation of the distribution of Refludan® as of 1 April 2012 as well as on switching patients currently taking Refludan® to treatment alternatives in due time.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Risk of second primary malignancies PDF, 479KB, File is accessible Date: 20. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

Important information on the risk of second primary malignancies in patients treated with Revlimid® (lenalidomide). Results of the benefit-risk review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines …

Information letter regarding Methergin® (methylergometrine maleate): Withdrawal of Methergin® oral solution from the market, safety information for the use of Methergin® solution for injection PDF, 57KB, File is accessible Date: 14. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methylergometrine maleate

The pharmaceutical manufacturer issues information on the withdrawal of Methergin® oral solution from the market due to case reports of adverse drug reactions in connection with medication errors/misuse in neonates. In addition, safety …

Dear Doctor Letter (Rote-Hand-Brief) on Revatio® (sildenafil citrate): Increased risk of mortality in paediatric patients with pulmonary arterial hypertension (PAH) PDF, 215KB, File is accessible Date: 06. October 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sildenafil citrate

Important new safety information on the increased risk of mortality in paediatric patients with pulmonary arterial hypertension (PAH) in connection with the use of higher than recommended doses of Revatio® (sildenafil citrate).

Dear Doctor Letter (Rote-Hand-Brief) on Multaq® (dronedarone): Restrictions regarding the use of Multaq® PDF, 439KB, File is accessible Date: 30. September 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dronedarone

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has decided on restrictions as well as additional contraindications and warnings regarding the use of Multaq®.

Dear Doctor Letter (Rote-Hand-Brief) on Apidra® cartridges (insulin glulisine [produced by recombinant DNA technology]): Shortage of Apidra®

PDF, 81KB, File is accessible
Date: 26. September 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: insulin glulisine

Information on a temporary shortage in the supply of Apidra 3 ml cartridges. In Germany, this concerns the following products: Apidra® cartridge, Apidra® cartridge for OptiClik®, Apidra® SoloStar®, Apidra® OptiSet®.

Dear Doctor Letter (Rote-Hand-Brief) on Nplate® (romiplostim): Risk of disease progression of pre-existing myelodysplastic syndrome (MDS) to acute myeloid leukemia (AML) PDF, 427KB, File is accessible Date: 16. September 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: romiplostim

Important safety-relevant information on the risk of disease progression to an acute myeloid leukemia with romiplostin (Nplate®) use in patients with myelodysplastic syndrome (MDS).

Dear Doctor Letter (Rote-Hand-Brief) on Caelyx® (pegylated liposomal doxorubicin): Supply failure PDF, 114KB, File is accessible Date: 06. September 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

From the middle of September a temporary supply failure of Caelyx® (pegylated liposomal doxorubicin) is likely to ocur resulting in a further decline in patient supply.

Dear Doctor Letter (Rote-Hand-Brief) on Caelyx® (pegylated liposomal doxorubicin): Likely shortage PDF, 116KB, File is accessible Date: 08. August 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

Likely global shortage of Caelyx® (pegylated liposomal doxorubicin) possibly resulting in supply problems for patients in Germany.

Dear Doctor Letter (Rote-Hand-Brief) on Sprycel® (dasatinib): Potential risk of pulmonary arterial hypertension PDF, 363KB, File is accessible Date: 03. August 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dasatinib

The pharmaceutical entrepreneur is sending out a Dear Doctor Letter giving information on the potential risk of pre-capillary, pulmonary arterial hypertension (PAH) under treatment with Sprycel® (dasatinib).

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing pioglitazone (Actos®, Competact®, Tandemact®): New contraindications and warnings due to a slightly increased risk of bladder cancer PDF, 155KB, File is accessible Date: 01. August 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pioglitazone

The pharmaceutical entrepreneur is sending out a Dear Doctor Letter on Actos®, Competact® and Tandemact® giving information on new contraindications and warnings due to a slightly increased risk of bladder cancer.