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-2026-0059
Egyptian Drug Authority · Egypt
DEA-EG-2026-0059
Tier 1 · Regulator-publishedUnclassifiedMise en garde au publicStatus · active
Issuing authority
Egyptian Drug Authority (EDA)
Authority reference
Periodic report no.(59) For 2026
Date issued
Jun 2026
Recorded by us
2026-09-06 19:45:29 UTC
Produit
Keytruda injection 100 mg \4 ml
INN / active substance
Not stated by the issuing authority
Dosage form
Not stated by the issuing authority
Strength
Not stated by the issuing authority
Fabricant
Not stated by the issuing authority
Manufacturer country
Not stated by the issuing authority
MAH or importer
Not stated by the issuing authority
Numéros de lot
B258364
Dates de péremption
Not published with the notice
Action type
Mise en garde au public
Classification
Not stated by the issuing authority
Indicative severity
Not assessed by Drug Eye Africa
Defect category
Falsifié
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
Texte de l’avis
Keytruda injection 100 mg \ 4 ml B258364رقم التشغيلة 2029-05 MSD وذلك بناءً على ماورد إلينا من شركة MSD حيث افادت ان جميع العبوات التي تحمل رقم التشغيلة الموضحة بعاليه مجهولة المصدر ولم يتم تصنيعها بمعرفتهم وقف تداول و ضبط وتحريز المستحضر مجهول المصدر. عدم شراء المستحضرات الصيدلية الا من الصيدليات المرخصة 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 تاريخ الإنتهاء سبب التحذير الإجراءات التصحيحية نصائح للمستهلكين هذا التنبيه خاص بالتشغيلات الواردة في المنشور فقط ولا ينطبق على تداول المستحضر بشكل عام اسم الشركة التابع لها المستحضر
Original language: ar
Texte de l’avis en anglais
Notice. Keytruda injection 100 mg/4 ml, of MSD, batch number B258364, expiry 05/2029. On the basis of what MSD reported to the Authority, all packs bearing the batch number set out above are of unknown origin.
Machine translation, produced by Drug Eye Africa and not checked by the issuing authority. The authority stated only the text above it.
Statut
En vigueur
Superseded by
Not superseded. This is the current version.
Version
11

Provenance

Verification tier 1

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

Primary source
https://www.edaegypt.gov.eg/media/s5vjdfiw/keytruda-2052-%D8%BA%D8%B4.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
68da7fb5dd0d8ec0e5d6028d5ea982fab91423ad39a9cdf73d084843db1d9fb8
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 20:50:22 UTC

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Cite this record
Drug Eye Africa (2026). DEA-EG-2026-0059: Keytruda injection 100 mg \4 ml — Mise en garde au public, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2026/dea-eg-2026-0059

Version history

v5Manufacturer removed: the named company states the packs are not theirs; the notice describes packs of unknown origin; 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-2026-0059