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443 results

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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®.