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List Item Lynparza-H-C-3726-X- 0016-G : EPAR - Assessment Report - Extension (PDF/3.33 MB) AdoptedFirst Published: 28/05/2018 Las.pdf

lynparza-h-c-3726-x-0016-g-epar-assessment-report-extension_en.pdf
Preview of List item Lynparza-H-C-3726-X- 0016-G : EPAR - Assessment Report - Extension (PDF/3.33 MB) AdoptedFirst published: 28/05/2018 Las
🔗 Source: ema.europa.eu
📊 Size: 3.33 MB
👤 Author: CHMP
⬇️ Downloads: 68

Summary

The European Medicines Agency (EMA) issued an assessment report on the extension of marketing authorisation for Lynparza (olaparib) on February 22, 2018. The report covers the quality, non-clinical, and clinical aspects of the medication, including its efficacy, safety, and risk management plan. The CHMP adopted the report, which includes information on the disease or condition treated, epidemiology, biologic features, clinical presentation, diagnosis, prognosis, and management. The report also discusses the chemical, pharmaceutical, and biological aspects of the medication, as well as its pharmacology, pharmacokinetics, toxicology, and ecotoxicity. The clinical aspects section covers pharmacokinetics, pharmacodynamics, clinical efficacy, and clinical safety. The report concludes with a benefit-risk balance assessment and recommendations for future quality development and pharmacovigilance activities.

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Description

The European Medicines Agency (EMA) issued an assessment report on the extension of marketing authorisation for Lynparza (olaparib) on February 22, 2018.

Technical Information

  • File Format: PDF
  • File Size: 3.33 MB
  • Pages: 163
  • Language: EN
  • Author: CHMP
  • Total Downloads: 68
  • Last Updated: 1 month ago

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This PDF document about List item Lynparza-H-C-3726-X- 0016-G : EPAR - Assessment Report - Extension (PDF/3.33 MB) AdoptedFirst published: 28/05/2018 Las provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into List item Lynparza-H-C-3726-X- 0016-G : EPAR - Assessment Report - Extension (PDF/3.33 MB) AdoptedFirst published: 28/05/2018 Las.

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