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WHO Drug Information Vol. 28 No. 2 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 |
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| 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; WHO collaboration with world pharmacopoeias; Technologies, standards and norms; Quality standards for pharmaceutical products; Essential medicines; Intensified efforts required to withdraw oral artemisinin-based monotherapies; Safety and efficacy news; Substandard and falsified products; Falsified antimalarial medicines in West and Central Africa; Stolen trastuzumab, pemetrexed and infliximab in Europe; Safety Information; Diacerein-containing medicines: restricted use; Domperidone: adverse effects on the heart.
- Hydroxyethyl starch-containing products: increased risk for patients with sepsisEpidural corticosteroid injection: rare but serious neurologic problems; Zolpidem, eszopiclone: impaired next-day alertness; Mirtazapine: abnormal heart rhythm; Vemurafenib: liver problems; Filgrastim and pegfilgrastim: capillary leak syndrome; Belimumab: opportunistic brain infection; Temozolomide: liver injury; RAS-acting agents: not to be used in combination; TNF-alpha inhibitors: reactivation of tuberculosis; Arsenic-containing dental pastes: genotoxicity; Serotonin-blocking medicines: serotonin syndrome.
- Panitumumab: rare but severe skin reactionsReviews started; Overview of safety reviews started; Regulatory news; Pre-marketing assessment; EMA launches adaptive licensing pilot project; EMA and TGA strengthen collaboration on orphan medicines; MHRA introduces early access to medicines scheme; EMA publishes draft guidelines for parallel scientific advice with health-technology-assessment bodies; Clinical trials; First-in-world pilot programme on multi-regional clinical trials; EU votes in new rules for clinical trials.
- EMA and FDA propose joint clinical investigation mechanism for rare children's diseasePost-marketing control; EU adopts specifications for post-marketing efficacy studies; EMA reports on implementation of new pharmacovigilance legislation; Guidance; EMA recommendations on seasonal influenza vaccine composition; MHRA confirms position on statins; Approvals; Miltefosine for leishmaniasis; Apremilast for psoriatic arthritis; Vintafolide for ovarian cancer, with diagnostic medicines etarfolatide and folic acid; Siltuximab for Castleman's disease.
- Vedolizumab for ulcerative colitis and Crohn's diseaseEmpagliflozin for type 2 diabetes; Simeprevir for chronic hepatitis C; Fluticasone furoate and vilanterol trifenatate for asthma and COPD; Generic oseltamivir for influenza; Topiramate for migraine prevention in adolescents; Long-acting recombinant coagulation factor IX concentrate for haemophilia B; Albiglutide for type 2 diabetes; Two sublingual pollen extracts for allergies; Ramucirumab for stomach cancer; Ceritinib for late-stage lung cancer; Trametinib for advanced melanoma; Vorapaxar to reduce cardiovascular risks.