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
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Register / Egypt / DEA-EG-2026-0061
Egyptian Drug Authority · Egypt
DEA-EG-2026-0061
Tier 1 · Regulator-publishedUnclassifiedAviso ao públicoStatus · active
Issuing authority
Egyptian Drug Authority (EDA)
Authority reference
Periodic report no.(61) For 2026
Date issued
Jun 2026
Recorded by us
2026-09-06 19:45:29 UTC
Produto
FLOPADEX 8mg Hard gelatin capsules 30
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
2504626
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
FLOPADEX 8mg Hard gelatin capsules 30 2504626و جميع التشغيلات التي تحمل نفس الاختلافات الموضحة بالمنشور رقم التشغيلة EVA PHARMA وذلك بناءً على ما ورد الينا من من شركة EVA PHARMA صاحبة المستحضر حيث افادت ان العبوات بالاختلافات الموضحة لا تخصها و لم يتم تصنيعها بمعرفتها. 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 المقلد يونيو 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
Texto do aviso em inglês
Notice. FLOPADEX 8mg hard gelatin capsules, 30s, of EVA Pharma, batch number 2504626 and every batch showing the same differences described in the circular, on the basis of what EVA Pharma, which owns the product, reported to the Authority.
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
12

Provenance

Verification tier 1

Where this record came from, and what is held to show it.

Primary source
https://www.edaegypt.gov.eg/media/ft1n1lyn/flopadex-8mg.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
0e120b884e182ae862a098fc27f5f02ea32192922bef3293ccb938cb3a8bfc80
SHA-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 20:50:27 UTC

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DEA-EG-2026-0070Jul 2026EGTagrisso 80 mg film-coated tabletsFESTPublic warningUnclassifiedTier 1 · Regulator-published
DEA-XXX-2026-000216 Jun 2026XXJAKAVI (ruxolitinib)none publishedPublic warningUnclassifiedTier 1 · Regulator-published
DEA-EG-2026-0062Jun 2026EGCOLOVERIN-D 30 film Coated Tablets251035APublic warningUnclassifiedTier 1 · Regulator-published
DEA-EG-2026-0060Jun 2026EGTears Guard Artificial Tears & Lubricant (Sterile Ophthalmic Solution)0425118Public warningUnclassifiedTier 1 · Regulator-published
Cite this record
Drug Eye Africa (2026). DEA-EG-2026-0061: FLOPADEX 8mg Hard gelatin capsules 30 — Aviso ao público, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2026/dea-eg-2026-0061

Version 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.

This record as data

/api/v1/notices/DEA-EG-2026-0061