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የኢትዮጵያ ምግብና መድኃኒት ባለስልጣን
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Ethiopian Food and Drug Administration
EFDA
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  • Home
  • About Us
    • About EFDA
    • Our Vision, Mission and Objectives
    • Organizational Structure
    • Accreditations
    • Powers and Duties
    • Appointed Inspectors
  • News and Events
  • Services
    • Our Services
    • e-service
    • Traceability
      • FAQ’s
    • Electronic Regulatory Information System(eRIS)
    • e-Reporting of ADR
    • Food Rapid Alert
  • Publications
    • All Publications
    • Policies, Legislation and Strategic Plan
      • Policies
      • Proclamations
      • Regulations
      • Strategic Plan
    • Directives and Guidelines
      • Medicine Directives
      • Medical Device Guidelines
      • Medicine Guidelines
      • Cosmetic Directive
      • Food Directives
      • Pharmacovigilance
      • Clinical Trials
    • Strategies
    • Manuals
    • Drugs lists and formularies
      • Drug Lists
      • Drug Formulary
    • Bulletins and Newsletter
      • Drug Bulletin
      • Food Bulletin
      • Pharmacovigilance Newsletter
      • EFDA Newsletter
    • Ethiopian public assessment report
    • Ethiopian Traceability System
  • Directorates
    • Director General
      • Food Sector Deputy Director General
      • Medicine Sector Deputy Director General
      • Medical Device Sector Deputy Director General
      • QMS Lead Executive Officer
      • Director General Office
      • Branch Coordination Lead Executive Officer
      • Intelligence & illegal Trade Prevention Lead Executive Officer
      • Chief Executive Officer
    • Medicine Sector Deputy Director General
      • Medicine Manufacturers Inspection and Enforcement Lead Executive Officer
      • Medicine Quality Control Lead Executive Officer
      • Medicine Registration & Market Authorization Lead Executive Officer
      • Pharmacovigilance & Clinical Trial Lead Executive Officer
    • Food Sector Deputy Director General
      • Food Registration and Licensing Lead Executive Officer
      • Food Safety and Quality Testing Lead Executive Officer
      • Food Inspection and Enforcement Lead Executives Officer
    • Medical Device Sector Deputy Director General
      • Medical Device Manufacturers Inspection and Enforcement Lead Executive Officer
      • Medical Device Quality Control Lead Executive Officer
      • Medical Device Registration & Market Authorization Lead Executive Officer
    • Chief Executive Officer
      • Basic Service Executive Officer
      • Competence & Human Resource Management Executive Officer
      • Information & Technology Executive Officer
      • Organizational Change Management Executive Officer
      • Procurement & Finance Executive Officer
      • Strategic Affair Executive Officer
      • Women & Inclusive Social Affair Executive Officer
    • Branch Office Head
      • Administration and Finance Team
      • Entry and Exit Products Inspection Lead Executive Officer
      • Food & Medicine Quality Control lead Executive Officer
      • Food Control Lead Executive Officer
      • Medicine & Medical Device Control Lead Executive Officer
  • COVID19
    • COVID19 FAQ’s
    • COVID19 publications
    • COVID-19 Quick Access
    • Privacy Policy
  • Public Information
  • Announcement
    • Tender
    • Notices
    • Vacancy
  • Contact

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SUMMARY OF PRODUCT CHARACTERISTICS TEMPLATE FOR Applicants

By EFDAJune 5, 2023

SUMMARY OF PRODUCT CHARACTERISTICS TEMPLATE FOR Applicants

PATIENT INFORMATION LEAFLET (PIL)TEMPLATE FOR Applicants

By EFDAJune 5, 2023

PATIENT INFORMATION LEAFLET (PIL)TEMPLATE FOR Applicants

GUIDELINE FOR PREPARATION AND PUBLICATION OF PUBLIC ASSESSMENT REPORTS FOR APPROVED MEDICINES

By EFDAMay 23, 2023

GUIDELINE FOR PREPARATION AND PUBLICATION OF PUBLIC ASSESSMENT REPORTS FOR APPROVED MEDICINES

Rosutrox 5 mg, 10 mg, 20 mg and 40 mg film coated tablets_SUMMARY OF PRODUCT CHARACTERISTICS

By EFDAMay 18, 2023

Rosutrox 5 mg, 10 mg, 20 mg and 40 mg film coated tablets_SUMMARY OF PRODUCT CHARACTERISTICS

Rosutrox 5 mg, 10 mg, 20 mg and 40 mg film coated tablets _ Public assessment summary report_Package label

By EFDAMay 18, 2023

Rosutrox 5 mg, 10 mg, 20 mg and 40 mg film coated tablets _ Public assessment summary report_Package label

PASURTA (erenumab) 140 mg per mL _ SUMMARY OF PRODUCT CHARACTERISTICS

By EFDAMay 18, 2023

PASURTA (erenumab) 140 mg per mL _ SUMMARY OF PRODUCT CHARACTERISTICS

PASURTA (erenumab) 140 mg per mL _ Public assessment summary report_Package label

By EFDAMay 18, 2023

PASURTA (erenumab) 140 mg per mL _ Public assessment summary report_Package label

Magnesium sulfate-Kalceks 500 mg per ml solution for injection_SUMMARY OF PRODUCT CHARACTERISTICS

By EFDAMay 17, 2023

Magnesium sulfate-Kalceks 500 mg per ml solution for injection_SUMMARY OF PRODUCT CHARACTERISTICS

Magnesium sulfate-Kalceks 500 mg per ml solution for injection_ Public assessment summary report_Package label

By EFDAMay 17, 2023

Magnesium sulfate-Kalceks 500 mg per ml solution for injection_ Public assessment summary report_Package label

OCTANATE 500 and OCTANATE 1000 _SUMMARY OF PRODUCT CHARACTERISTICS

By EFDAMay 17, 2023

OCTANATE 500 and OCTANATE 1000 _SUMMARY OF PRODUCT CHARACTERISTICS

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