RECORDS ARE PUBLISHED REGULATORY ACTIONS. FIELDS THE ISSUING AUTHORITY DID NOT PUBLISH ARE MARKED AS NOT STATED, NEVER FILLED IN.
Drug Eye AfricaNational Actions, Continental Reach
Register / Egypt / DEA-EG-2026-0017
Egyptian Drug Authority · Egypt
DEA-EG-2026-0017
Tier 1 · Regulator-publishedUnclassifiedPublic warningStatus · active
Issuing authority
Egyptian Drug Authority (EDA)
Authority reference
Periodic report no.(17) For 2026
Date issued
Mar 2026
Recorded by us
2026-09-06 19:45:29 UTC
Product
Epclusa® 100 mg/400 mg
INN / active substance
Not stated by the issuing authority
Dosage form
Not stated by the issuing authority
Strength
Not stated by the issuing authority
Manufacturer
Not stated by the issuing authority
Manufacturer country
Not stated by the issuing authority
MAH or importer
Not stated by the issuing authority
Batch numbers
Not published with the notice
Expiry dates
Not published with the notice
Action type
Public warning
Classification
Not stated by the issuing authority
Indicative severity
Not assessed by Drug Eye Africa
Defect category
Not stated by the issuing authority
Product type
Not stated by the issuing authority
ATC code
Not stated by the issuing authority
Affected markets
Egypt — no market beyond the issuing country was named on the notice
Cross-border event
Not linked to a cross-border event
Notice text
Epclusa® E800532 و2094-01Aرقمالتشغيلات Gilead Science Inc. وذلك بناءً على ما ورد الينا من شركة Gilead Science Inc.صاحبة المستحضر حيث افادت ان العبوات بالبيانات الموضحة بعاليهلا تخصها و لم يتم تصنيعها بمعرفتها مع العلم انه بالبحث في قاعدة بيانات هيئة الدواء فانه لم يتم رصد اي بيانات خاصة بتسجيل المستحضر حتيتاريخه وقف تداول و ضبط وتحريز المستحضر الغير مطابق للمواصفات في حالة الشك في المستحضر الصيدلى يتم الرجوع الى هيئة الدواء المصرية سواء بالإتصال بالخط الساخن 15301او الموقع الإلكترونى الخاص بالهيئة. يمكن الضغط على الرابطللإطلاع على الصور الخاصة بالمستحضر الغير مطابق للمواصفات. مارس 2026 منشور غش تجاري اسم المستحضر الشركة المنتجة سبب التحذير الإجراءات التصحيحية نصائح للمستهلكين هذا التنبيه خاص بالتشغيلات الواردة في المنشور فقط ولا ينطبق على تداول المستحضر بشكل عام
Original language: ar
Notice text in English
Notice. Epclusa, batch numbers E800532 and 2094-01A, of Gilead Sciences Inc. On the basis of what Gilead Sciences Inc., which owns the product, has reported to the Authority, the packs bearing the particulars set out above are not theirs.
Machine translation, produced by Drug Eye Africa and not checked by the issuing authority. The authority stated only the text above it.
Status
Active
Superseded by
Not superseded. This is the current version.
Version
3

Provenance

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Copy taken
2026-09-06 20:48:58 UTC
Cite this record
Drug Eye Africa (2026). DEA-EG-2026-0017: Epclusa® 100 mg/400 mg — Public warning, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2026/dea-eg-2026-0017

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DEA-EG-2026-0017 — Epclusa® 100 mg/400 mg · Drug Eye Africa