Egyptian Drug Authority · Egypt
DEA-EG-2026-0035
Tier 1 · Regulator-publishedUnclassifiedPublic warningStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- Periodic report no.(35) For 2026
- Date issued
- Apr 2026
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Product
- 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
- 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
- S20491
- 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
- Keytruda injection 100 mg \ 4 ml
(25mg/ml)
S20491رقمالتشغيلة
19\4\2025 - 20\12\2029
MERCK & CO., INC.
طبقا لإفادة ادارة التفتيشعليالمستحضرات
الحيوية حول وجود عبوات مجهولة المصدر من
الصنف المذكور.
وقف تداول و ضبط وتحريز المستحضر مجهول
المصدر.
في حالة الشك في المستحضر الصيدلىيتم الرجوع
الى هيئة الدواء المصرية سواء بالإتصالبالخط
الساخن 15301او الموقعالإلكترونىالخاص
بالهيئة.
يمكن الضغط على الرابطللإطلاععلى الصور
الخاصة بالمستحضر الغير مطابق للمواصفات .
أبريل 2026
منشور
غش تجاري
اسم المستحضر
اسم الشركة المدون على
العبوات
سبب التحذير
الإجراءات
التصحيحية
نصائح
للمستهلكين
هذا التنبيه خاص بالتشغيلات الواردة في المنشور فقط ولا ينطبق
على تداول المستحضر بشكل عام
تاريخ الإنتاج والانتهاءOriginal language: ar
- Notice text in English
- Notice. Keytruda injection 100 mg/4 ml (25mg/ml), of Merck & Co., Inc., batch number S20491, dated 19/4/2025 to 20/12/2029. The biological products inspection department has reported packs of unknown origin of the product.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- Superseded by
- Not superseded.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
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
- 17ecf588ff38be7b549287c5ec7c4b86d72d043629810905957115bb10beba1eSHA-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 20:49:34 UTC
Cite this record
Drug Eye Africa (2026). DEA-EG-2026-0035: Keytruda injection 100 mg \4 ml — Public warning, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2026/dea-eg-2026-0035Version history
—No version history recorded for this record.
—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.