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Information Letter regarding Zyvoxid® 2 mg/ml solution for injection: Supply failure PDF, 122KB, File is accessible Date: 10. January 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: linezolid

The company Pfizer Pharma GmbH is circulating information that the medicinal product Zyvoxid® 2 mg/ml solution for injection can currently not be supplied.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing dihydroergotamine: Restrictions of indication PDF, 154KB, File is accessible Date: 06. January 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dihydroergotamine

New restrictions of certain indications have been decided for medicinal products containing dihydroergotamine.

Information Letter on Increlex® 10 mg/ml solution for injection PDF, 180KB, File is accessible Date: 23. December 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mecasermin, recombinant human IGF-1

The company Ipsen Pharma GmbH is sending out information that the supply with Increlex® (mecasermin) is no longer interrupted.

Quinine (Limptar® N): hearing under the graduated plan procedure ("Stufenplanverfahren"), stage II Date: 20. December 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: quinine

In its letter dated 19 December 2013, the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) has initiated a written hearing regarding the risk of serious haematological …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing temozolomide: risk of severe liver toxicity PDF, 213KB, File is accessible Date: 13. December 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: temozolomide

The companies concerned point out that cases of liver injury, including liver failure with lethal outcome, have been reported in patients treated with medicinal products containing temozolomide. The liver toxicity may not appear until several …

Dear Doctor Letter (Rote-Hand-Brief) on Iclusig® (ponatinib): Updated information on the risk of vascular occlusion PDF, 95KB, File is accessible Date: 09. December 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ponatinib

Extension of warnings to include the risk of severe vascular occlusion associated with ponatinib.

Diclofenac: realisation of the EU Commission's implementing decision Date: 06. December 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: diclofenac

Based on the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) and on the position of the Coordination Group (CMDh), the European Commission decided on 25 September 2013 to adapt …

Dear Doctor Letter (Rote-Hand-Brief) on EFIENT® (prasugrel): increased risk of serious bleeding PDF, 910KB, File is accessible Date: 03. December 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: prasugrel

The company Lilly Deutschland GmbH is circulating information that patients with unstable angina pectoris (UA)/NSTEMI receiving EFIENT® prior to diagnostic coronary angiography have an increased risk of serious bleeding.

Iclusig®: Risk of blood clots Date: 25. November 2013 Topics: Pharmakovigilanz Type: Risk information

Active substance: ponatinib

The Committee for Medicinal Products for Human Use (CHMP) recommends updating the product information of the leukaemia medicine Iclusig® (ponatinib) to include new warnings in order to minimise the risk of a higher rate of blood clots.

Dear Doctor Letter (Rote-Hand-Brief) on Oncaspar® solution for injection (pegasparaginase): Possible quality deficiency PDF, 364KB, File is accessible Date: 19. November 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegasparaginase

The company Sigma-Tau Arzneimittel GmbH is circulating information that individual containers from different batches have exhibited fine cracks that can lead to leakage (assumed incidence: one in every 5,000 injection vials). Due to these fine …