Egyptian Drug Authority · Egypt
DEA-EG-2023-0001
Tier 1 · Regulator-publishedUnclassifiedسحبStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- Periodic report no. (1) For 2023
- Date issued
- 11 Apr 2023
- Recorded by us
- 2026-09-06 19:45:29 UTC
- المستحضر
- Atozuril 0.5% 500mg /100mg powder
- 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
- 213772
- تواريخ انتهاء الصلاحية
- Not published with the notice
- Action type
- سحب
- التصنيف
- 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
- نص الإخطار
- @egyptiandrugauthority
www.edaegypt.gov.eg
15301
١١ ابريل ٣٢٠٢
وذلـــك لكـــون المســـتحضر صـــادر لـــه عـــدم مطابقة للتشـــغيلة
الموضحة من قبل معامل هيئة الدواء المصرية.
يتم ضبط وتحريز كافة العبوات من المستحضر الموضح أدناه:
منشور
Atozuril 0.5% 500mg /100mg powder
213772رقم التشغيلة
الشركة المصنعة و صاحبة المستحضر:اتكو فارما لصالح ابو النجا
Atozuril 0.5%
500mg /100mg
powderOriginal language: ar
- نص الإخطار بالإنجليزية
- Circular, April 2023. All packs of the product described below are to be impounded and seized: Atozuril 0.5% 500mg/100mg powder, batch number 213772. The manufacturer and owner of the product is Atco Pharma, on behalf of Abou El Naga. A finding of non-conformity has been issued for the stated batch by the laboratories of the Egyptian Drug Authority.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- Superseded by
- Not superseded.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
- 1
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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 5a2d705208fadfe96fc6aebf8a297f4ef08e9e8ce5937dc51e17be3f3b973b5eSHA-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 20:36:30 UTC
Cite this record
Drug Eye Africa (2023). DEA-EG-2023-0001: Atozuril 0.5% 500mg /100mg powder — سحب, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2023/dea-eg-2023-0001Version 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.