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WHO Drug Information Vol. 28 No. 1 2014.
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 |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Geneva :
World Health Organization,
2014.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Cover; Contents; Regulatory harmonization; The International Generic Drug Regulators Pilot; Introduction; Exploratory meeting; Preliminary surveys; The path forward; Operating procedures; Progress to date; Decentralised Procedure as a model for cooperation; Some observations; Conclusion; References; WHO support for medicines regulatory harmonization in Africa: focus on East African Community; The African Medicines Registration Harmonization initiative; The role of Regional Economic Communities; The EAC Medicines Registration Harmonization project; NMRA assessments.
- Progress towards harmonized registrationCollaboration with other initiatives; Conclusion; References; Technologies, standards and norms; Standards for biological products; Biotherapeutic products; Adjuvanted vaccines; Typhoid conjugate vaccines; Reference preparations; References; Safety and efficacy issues; Combined hormonal contraceptives and venous thromboembolism; Clobazam: serious skin reactions; Amiodarone: pulmonary toxicity; Methylphenidate: rare risk of long-lasting erections in males; Glibenclamide: risk of hypoglycaemia in elderly and renal-impaired patients.
- Subcutaneous epoetin alfa: contraindicated in Singapore in chronic kidney disease patientsAcipimox: only to be used as additional or alternative treatment; Estradiol-containing creams: new restrictions; Clopidogrel: rare reports of acquired haemophilia; Sodium phosphate products in high doses: severe dehydration; Emergency contraceptives
- high bodyweight may reduce effectiveness; Testosterone: possible risk of stroke and heart attack; Lithium: hypercalcaemia and hyperparathyroidism; Saxagliptin: possible risk of heart failure.
- Strontium ranelate: further restrictions due to cardiovascular risksMethysergide-containing medicines: new restrictions; Regulatory action and news; Regulatory options in the fight against antimicrobial resistance; EMA and FDA collaborate on bioequivalence inspections; Tafenoquine receives FDA Breakthrough Therapy designation; Regulatory action against Ranbaxy's Toansa facility; WHO response to FDA findings at Ranbaxy's Toansa site; New partnership to strengthen regulatory systems; Canada-US Common Electronic Submissions Gateway.
- Updated guidance for annual strain change of seasonal influenza vaccinesEMA and FDA strengthen collaboration on pharmacovigilance; European Medicines Agency publishes first summary of a risk-management plan for a medicine; EMA and FDA extend parallel assessment pilot; Australia and New Zealand harmonization activities; Approvals; First adjuvanted vaccine for H5N1 avian influenza approved; Umeclidinium and vilanterol approved for chronic obstructive pulmonary disease; Dapaglifozin approved for type 2 diabetes; Trametinib and dabrafenib approved in combination for advanced melanoma.