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WHO Drug Information Vol. 27 No. 4 2013.
WHO Drug Information communicates pharmaceutical information that is either developed and issued by WHO or transmitted to WHO by research and regulatory agencies throughout the World. The journal also includes regular presentations of newly proposed and recommended International Nonproprietary Names...
| Clasificación: | Libro Electrónico |
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| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Geneva :
World Health Organization,
2013.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Cover; Contents; WHO Prequalification of Medicines Programme; WHO launches the PQP Collaborative Registration Procedure; Principles; Information sharing; Experience; Registration procedures; Adherence to timelines; Experience with specific aspects of collaboration; Format of national submissions; Dealing with product differences; Country-specific conditions; Communication of technical issues; Benefits of the Collaborative Registration Procedure for key stakeholders; Conclusion; Next steps; References; Quality Assurance of Medicines.
- Review of the MQAS and preparation of a harmonized assessment tool for procurement agenciesAssessment tool based on the Model Quality Assurance System for Procurement Agencies: Aide Memoire for Inspections; Module I: General requirements for procurement agencies; Module II: Prequalification; Module III: Purchasing; Module IV: Receiving and storage; Module V: Distribution; Module VI: Reassessment; Safety and Efficacy Issues; Contaminated dextromethorphan; World Health Organization; Falsified artemether and lumefantrine circulating in Cameroon; World Health Organization.
- Ponatinib: increased reports of serious blood clotsUnited States of America; Intravenous tigecycline: increased risk of death; United States of America; Cinacalcet: hypocalcaemia and arrhythmia; Canada; Reference; Ofatumumab and rituximab: reactivation of HBV infection; United States of America; Reference; Hydroxyethyl-starch solutions: only for hypovolaemia; European Union; Reference; Artesunate: haemolytic anaemia; World Health Organization; Reference; Carbamazepine: HLA-B*1502 genotype testing; Singapore; Epoetin alfa: increase in pure red cell aplasia; Singapore.
- Sunitinib malate: cutaneous reactionsCanada; Reference; Panitumumab: RAS status before treatment; United Kingdom; Reference; Fentanyl patches: colour changes to avoid exposure; United States of America; Ornidazole: adverse eye effects; New Zealand; Statins: risk of acute kidney injury; New Zealand; Reference; Low molecular weight heparin: risk of spinal column bleeding and paralysis; United States of America; Pazopanib: hepatotoxicity; Canada; Reference; Regadenoson and adenosine: fatal cardiac reactions; United States of America; Reference; Thiocolchicoside: risk of aneuploidy.
- European UnionReference; Regulatory Action and News; Helsinki Declaration: 2013 revision; EudraCT: new version launched; European Union; WHO PQP now charging application fees; World Health Organization; Reference; EudraGMDP database: improved information-sharing; European Union/Japan; Reference; Medical device identification system; United States of America; Macitentan approved for pulmonary arterial hypertension; United States of America; Liposorber Apheresis System® approved for paediatric glomerulosclerosis; United States of America; Reference; Riociguat approved for pulmonary hypertension.