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819 results

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Pharmacovigilance Risk Assessment Committee (PRAC) Date: 19. January 2013 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee is responsible for assessing and monitoring safety issues for human medicines; it is the successor to the Pharmacovigilance Working Party (PhVWP) of the Committee for …

Dear Doctor Letter (Rote-Hand-Brief) on Pradaxa® (dabigatran etexilate): New contraindication PDF, 337KB, File is accessible Date: 09. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dabigatran etexilate

The pharmaceutical manufacturer is sending out information that the medicinal product Pradaxa® is now contraindicated in patients with artificial heart valves who require anticoagulant treatment.

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): Recommendations revised in analogy to the recommendations for first use regarding cardiovascular monitoring in case of renewed treatment PDF, 56KB, File is accessible Date: 08. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

Revised recommendations on repeated cardiovascular monitoring in case of renewed treatment with Gilenya®. These recommendations apply for patients following interruption of treatment and for patients with bradyarrhythmia requiring therapy …

Dear Doctor Letter (Rote-Hand-Brief) on Angiox® (bivalirudin): Inappropriate "bolus-only" dosing for PCI PDF, 235KB, File is accessible Date: 08. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bivalirudin

Communication for healthcare professionals based on reports of IV bolus injections of Angiox® (bivalirudin) alone without immediately following IV infusions. The resulting sub-therapeutic plasma concentrations bear the risk of ineffective …

Dear Doctor Letter (Rote-Hand-Brief) on Tredaptive®: Results of a clinical study PDF, 781KB, File is accessible Date: 02. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: niacin, laropiprant

Recommendation not to start new patients on treatment with Tredaptive® as the primary endpoint could not be met in the cardiovascular endpoint study HPS2-THRIVE.

Tredaptive®, Pelzont®, Trevaclyn® (niacin/laropiprant): start of a review procedure in accordance with Article 20 of Regulation (EC) No. 726/2004 Date: 02. January 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: niacin | laropiprant

The European Medicines Agency (EMA) has initiated a review procedure regarding the lipid-lowering drugs Tredaptive®/Pelzont®/Trevaclyn® after the MAH of the medicinal products had published preliminary results of a large, long-term study.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Risk of liver diseases PDF, 268KB, File is accessible Date: 10. December 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

Information for health care professionals regarding the risk of liver diseases in connection with the use of Revlimid® (lenalidomide) in the presence of other risk factors.

Information Letter on Tyverb® (lapatinib): Combination treatment with Tyverb® (lapatinib) less effective in certain settings PDF, 1,010KB, File is accessible Date: 10. December 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lapatinib

Important information on Tyverb® (lapatinib): Comparative data from clinical trials have shown that in certain settings combination treatments containing lapatinib are less effective than those containing trastzumab (Herceptin®).

Dear Doctor Letter (Rote-Hand-Brief) on Ultravist® (iopromide): Batch recall PDF, 351KB, File is accessible Date: 15. November 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: iopromide

It cannot be ruled out with certainty that the delivered batch 22763A of the medicinal product Ultravist® 300 10x10 ml (PZN 3049076) has been intermixed with Primovist® 10 ml (labelled as Ultravist 30). Therefore, all stocks of this batch are …

Diphenhydramine, doxylamine and dimenhydrinate: Over-the-counter first-generation H1-antihistamines in infants and young children Date: 09. November 2012 Topics: Pharmakovigilanz Type: Risk information

Active substance: diphenhydramine, doxylamine and dimenhydrinate

Children under the age of 3 years are especially at risk of experiencing adverse effects of first-generation H1-antihistamines. The BfArM points out that these medicinal products are only to be administered to infants and young children under …