Egyptian Drug Authority · Egypt
DEA-EG-2026-0003
Tier 1 · Regulator-publishedUnclassifiedAviso ao públicoStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- Periodic report no.(3) For 2026
- Date issued
- Jan 2026
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Produto
- Xtandi 40 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
- Fabricante
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Números de lote
- 20K0203
- Prazos de validade
- Not published with the notice
- Action type
- Aviso ao público
- Classificação
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Falsificado
- 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
- Texto do aviso
- Xtandi 40 mg
Astellas Pharma
20K0203
طبقا لإفادة شركةAstellas Pharma -
صاحبة المستحضر-حول وجود عبوات
مقلدة من الصنف المذكور.
وقف تداول و ضبط وتحريز المستحضر
المقلد.
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 المقلد.
يناير2026
منشور
غش تجاري
اسم المستحضر
الشركة المنتجة
رقم التشغيلة
سبب التحذير
الإجراءات
التصحيحية
نصائح
للمستهلكين
هذا التنبيه خاص بالتشغيلات الواردة في المنشور فقط ولا ينطبق
على تداول المستحضر بشكل عامOriginal language: ar
- Texto do aviso em inglês
- Notice. Astellas Pharma, which owns the product, has reported counterfeit packs of Xtandi 40 mg, batch 20K0203. Circulation is to stop and the counterfeit product is to be impounded and seized.Machine translation, produced by Drug Eye Africa and not checked by the issuing authority. The authority stated only the text above it.
- Estado
- Em vigor
- Superseded by
- Not superseded. This is the current version.
- Version
- 11
Where this record came from, and what is held to show it.
- Primary source
- https://www.edaegypt.gov.eg/media/4gwfd3nr/xtandi-%D8%BA%D8%B4-%D8%AA%D8%AC%D8%A7%D8%B1%D9%8A-1760.pdf
- 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
- 5c1556cf9750de44fe07304567fc65448e7382ec774866d3ee84b697c6a9ff8dSHA-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 20:48:30 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-2026-0003: Xtandi 40 mg — Aviso ao público, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2026/dea-eg-2026-0003Version history
v5Manufacturer removed: 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.