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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.

Rote-Hand-Brief on Revlimid® PDF, 479KB, File is accessible Date: 20. October 2011 Topics: Pharmakovigilanz Type: Download

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 on Methergin® PDF, 57KB, File is accessible Date: 14. October 2011 Topics: Pharmakovigilanz Type: Download

Active substance: methylergometrine maleate

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 …

Rote-Hand-Brief on Revatio® PDF, 215KB, File is accessible Date: 06. October 2011 Topics: Pharmakovigilanz Type: Download

Active substance: sildenafil citrate

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).

Rote-Hand-Brief on Multaq® PDF, 439KB, File is accessible Date: 30. September 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dronedarone

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®.

Rote-Hand-Brief on Apidra® PDF, 81KB, File is accessible Date: 26. September 2011 Topics: Pharmakovigilanz Type: Download

Active substance: insulin glulisine

Additional information (available in German only):

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®.

Rote-Hand-Brief on Nplate® PDF, 427KB, File is accessible Date: 16. September 2011 Topics: Pharmakovigilanz Type: Download

Active substance: romiplostim

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.

Rote-Hand-Brief on Caelyx® PDF, 114KB, File is accessible Date: 06. September 2011 Topics: Pharmakovigilanz Type: Download

Active substance: pegylated liposomal doxorubicin

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.

Rote-Hand-Brief on Caelyx® PDF, 116KB, File is accessible Date: 05. August 2011 Topics: Pharmakovigilanz Type: Download

Active substance: pegylated liposomal doxorubicin

Rote-Hand-Brief on Sprycel® PDF, 363KB, File is accessible Date: 03. August 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dasatinib

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.

Rote-Hand-Brief on Actos®, Competact® und Tandemact® PDF, 155KB, File is accessible Date: 01. August 2011 Topics: Pharmakovigilanz Type: Download

Active substance: pioglitazone

Changes in Summary of Product Characteristics and Package Leaflet

Rote-Hand-Brief on Vimpat® PDF, 46KB, File is accessible Date: 29. July 2011 Topics: Pharmakovigilanz Type: Download

Active substance: lacosamide

Dear Doctor Letter (Rote-Hand-Brief) on Vimpat® (lacosamide) 15 mg/ml syrup: Recall due to a quality defect PDF, 46KB, File is accessible Date: 29. July 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lacosamide

As of 15 September 2011, the pharmaceutical entrepreneur is recalling the medicinal product Vimpat® 15 mg/ml syrup from the market due to a quality defect. Other pharmaceutical forms are not affected.

Dear Doctor Letter (Rote-Hand-Brief) on Multaq® (dronedarone): New study results on increased cardiovascular risks PDF, 321KB, File is accessible Date: 29. July 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dronedarone

New data from a prematurely discontinued study (PALLAS study) indicate a significantly increased risk of cardiovascular adverse events in patients with permanent atrial fibrillation due to treatment with dronedarone.

Champix®: The European Medicines Agency confirms a positive benefit-risk balance Date: 28. July 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: varenicline

The benefits of Champix® as a smoking-cessation medicine outweigh the reported slight increase in cardiovascular events. The European Medicines Agency has confirmed that the benefit-risk balance for Champix® (varenicline) remains positive, …

Rote-Hand-Brief on Multaq® PDF, 321KB, File is accessible Date: 27. July 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dronedarone

Pioglitazone: The European Medicines Agency recommends new contraindications and warnings for medicinal products containing pioglitazone due to a slightly increased risk of bladder cancer Date: 22. July 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: pioglitazone

In its July meeting, the Committee for Medicinal Products for Human Use of the European Medicines Agency finalised the benefit-risk assessment for medicinal products containing pioglitazone. This confirms a slightly increased occurrence of …

Dronedarone: EMA renews information on the benefit-risk assessment of Multaq®
Date: 22. July 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: dronedarone

The European Medicines Agency is currently reviewing the benefit-risk balance of the antiarrhythmic agent dronedarone (Multaq®). New study data (PALLAS study) indicate a significantly increased risk of cardiovascular adverse events in patients …

Rote-Hand-Brief on Cardioxane® PDF, 279KB, File is accessible Date: 18. July 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dexrazoxane