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Use of valproate (and related substances) during pregnancy: initiation of a European safety review Date: 15. October 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

At the request of Great Britain, the European Medicines Agency (EMA) has initiated a review procedure in accordance with Article 31 of Directive 2001/83/EC regarding valproate, valproic acid and related substances.

Numeta G 16% E® (nutrient solution for term infants and children up to 2 years of age): Possible risk of hypermagnesemia PDF, 89KB, File is accessible Date: 09. October 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: nutrient solution for term infants and children up to 2 years of age

The company Baxter Deutschland GmbH is sending out information that administration of the medicinal product Numeta G 16% E® to term infants and children up to 2 years of age can possibly lead to the risk of hypermagnesemia.

Dear Doctor Letter (Rote-Hand-Brief) on short-acting beta-agonists/beta 2-sympathomimetic agents (SABAs) for obstetric indications - including Partusisten® (fenoterol): Restrictions of indication PDF, 818KB, File is accessible Date: 01. October 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fenoterol

The company Boehringer Ingelheim communicates important restrictions regarding the use of short-acting beta-agonists/beta 2-sympathomimetic agents (SABAs) for obstetric indications.

Application for changing the legal status Date: 26. September 2013 Topics: Pharmakovigilanz Arzneimittelsicherheit Type: Article

Application for changing the legal status

Dear Doctor Letter (Rote-Hand-Brief) on Lariam® (mefloquine): Risk of neuropsychiatric and other serious adverse reactions as well as inclusion of new contraindications PDF, 2MB, File is accessible Date: 10. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mefloquine

Important information regarding new contraindications (Blackwater fever, severe impairment of liver function) as well as on the risk of neuropsychiatric and other serious adverse reactions under Lariam® (mefloquine) for malaria …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing risperidone or paliperidone: Risk of an intraoperative floppy iris syndrome (IFIS) PDF, 817KB, File is accessible Date: 09. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: risperidone, paliperidone

Important information on the risk of an intraoperative floppy iris syndrome (IFIS) in connection with administration of risperidone or paliperidone to patients undergoing cataract surgery.

Information Letter on the new anticoagulants Eliquis® (apixaban), Pradaxa® (dabigatran etexilate) and Xarelto® (rivaroxaban): Reducing the risk of haemorrhages PDF, 108KB, File is accessible Date: 06. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: apixaban

The marketing authorisation holders request observation of risk factors for haemorrhages as well as of dosage instructions, contraindications, warnings and precautionary measures for use in order to reduce the risk of haemorrhages.

Information Letter on clopidogrel: Risk of acquired haemophilia PDF, 145KB, File is accessible Date: 04. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: clopidogrel

The marketing authorisation holders are circulating information on a small number of cases of acquired haemophilia associated with clopidogrel treatment in patients without a history of haemostasis.

Zyvoxid® 2 mg/ml solution for injection (linezolid): limited supply with immediate effect PDF, 116KB, File is accessible Date: 30. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: linezolid

The company Pfizer Pharma GmbH is circulating information that with immediate effect the medicinal product Zyvoxid® 2 mg/ml solution for injection is available again to a limited extent.

Dear Doctor Letter (Rote-Hand-Brief) on Imnovid® (pomalidomide): Information on important aspects of clinical use PDF, 591KB, File is accessible Date: 28. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pomalidomide

The marketing authorisation holder Celgene is circulating information on important aspects regarding the clinical use of the new medicinal product Imnovid® (pomalidomide).