Egyptian Drug Authority · Egypt
DEA-EG-2026-0017
Tier 1 · Regulator-publishedUnclassifiedتحذير للجمهورStatus · 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
- المستحضر
- 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
- الشركة المصنعة
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- أرقام التشغيلات
- E800532 · 2094-01A
- تواريخ انتهاء الصلاحية
- Not published with the notice
- Action type
- تحذير للجمهور
- التصنيف
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- مغشوش
- 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
- نص الإخطار
- 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 عامOriginal language: ar
- نص الإخطار بالإنجليزية
- 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.
- الحالة
- سارٍ
- Superseded by
- Not superseded. This is the current version.
- Version
- 11
Where this record came from, and what is held to show it.
- Copy of the source
- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn. Not yet published at an address you can open.Ask us for it and check it against the fingerprint below.
- Fingerprint
- c35c9bafa27ff91391b3ac7f4c0c2894afb45b3f9a16976d550f03e346ce40fcSHA-256 of the copy held. Any file that produces this number is that copy, byte for byte; any file that does not is a different document.
- Copy taken
- 2026-09-06 20:48:58 UTC
| Reference | Date | Country | Product | Batches | Action | Class | Source |
|---|---|---|---|---|---|---|---|
| DEA-XXX-2026-0003 | 03 Jul 2026 | XX | DARZALEX (daratumumab) | MYS7381 · STV1K01 | Public warning | Unclassified | Tier 1 · Regulator-published |
| DEA-EG-2026-0070 | Jul 2026 | EG | Tagrisso 80 mg film-coated tablets | FEST | Public warning | Unclassified | Tier 1 · Regulator-published |
| DEA-XXX-2026-0002 | 16 Jun 2026 | XX | JAKAVI (ruxolitinib) | none published | Public warning | Unclassified | Tier 1 · Regulator-published |
| DEA-EG-2026-0062 | Jun 2026 | EG | COLOVERIN-D 30 film Coated Tablets | 251035A | Public warning | Unclassified | Tier 1 · Regulator-published |
| DEA-EG-2026-0061 | Jun 2026 | EG | FLOPADEX 8mg Hard gelatin capsules 30 | 2504626 | Public warning | Unclassified | Tier 1 · Regulator-published |
| DEA-EG-2026-0060 | Jun 2026 | EG | Tears Guard Artificial Tears & Lubricant (Sterile Ophthalmic Solution) | 0425118 | Public warning | Unclassified | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2026). DEA-EG-2026-0017: Epclusa® 100 mg/400 mg — تحذير للجمهور, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2026/dea-eg-2026-0017Version history
v5Manufacturer removed: the named company states the packs are not theirs; the notice describes the packaging as counterfeit (correction)
—Corrections appear here and in the site-wide log. Records are superseded, never deleted.
Verification
Tier 1 — Published by the issuing regulator on its own channel and captured by Drug Eye Africa, with the source document archived.
Indexing
This record is indexable: it is dated, names a product, and carries either a batch number or a stated reason.