WHO Drug Information Vol. 26, No. 1, 2012

Contenido

Regulatory Focus

Regulation of medicines in China
Paediatric Medicines
Better medicines for children: pharmaceutical formulations
Benznidazole: child-adapted dosage form approved
Use of drugs in paediatric health conditions increasing


Safety and Efficacy Issues

Bevacizumab: severe infectious endophthalmitis and blindness
Ursodeoxycholic acid: serious hepatic events
Simvastatin with amiodarone: dosage review
Fenofibric acid: the ACCORD lipid trial
BCG vaccine: lymphadenitis
Dabigatran etexilate mesylate: bleeding events
Dabigatran etexilate: caution in the elderly and renally impaired
Dabigatran: risk of bleeding
Pneumovax 23®: revaccination recommendations
Somatropin-containing medicines: positive benefit-risk balance
Pholcodine-containing coughs medicines
Antipsychotics in children and adolescents: cardiometabolic reactions
Citalopram hydrobromide: dose dependent QT prolongation
Brentuximab vedotin: new warning and contraindication
Quetiapine: information updated
Aliskiren: cardiovascular and renal events
Natalizumab: progressive multifocal leukoencephalopathy
Boceprevir: HIV protease inhibitor interactions
Bortezomib: fatal if given intrathecally

Regulatory Action and News
Bevacizumab: suspension for metastatic breast cancer
Drotrecogin alfa: withdrawal
Dextropropoxyphene-containing analgesics cancelled
Vemurafenib approved for metastatic or unresectable melanoma
Ecallantide: marketing authorization application withdrawal
Sitagliptin and pioglitazone: marketing authorization application withdrawal
Voclosporin: marketing authorization application withdrawal
Desloratadine: marketing authorization application withdrawal
Electronic CTD implementation
ATC/DDD Classification
ATC/DDD Classification (temporary)
ATC/DDD Classification (final)

Recent Publications, Information and Events
Pharmacovigilance Toolkit

Uppsala Monitoring Centre signals document: increased availability

Learning module: selective serotonin reuptake inhibitors
Medicines access survey
ATC/DDD methodology course
Access and Control Newsletter
Managing access to medicines and health technologies
International Nonproprietary Names


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