Egyptian Drug Authority · Egypt
DEA-EG-2024-0030
Tier 1 · Regulator-publishedUnclassifiedRappelStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- periodic report no (30) For 2024
- Date issued
- May 2024
- Recorded by us
- 2026-09-06 19:45:29 UTC
- Produit
- Novoral Mouth Refreshner Spray
- 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
- سمارتك للمستحضرات الطبية والتجميل لصالح شركة ميدكسير فارما
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Numéros de lot
- 22218b
- Dates de péremption
- Not published with the notice
- Action type
- Rappel
- 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
- Texte de l’avis
- Novoral mouth refreshner spray
22218b
سمارتك للمستحضرات الطبية
والتجميل لصالح شركة ميدكسير فارما
ذلك لكون المستحضر صادر له عدم
مطابقة للتشغيلة الموضحة منقبل
معامل هيئة الدواء
سحب ووقف تداول وتحريز
في حالة الشك في المستحضر الصيدلى يتم
الرجوع إلى هيئة الدواء المصرية سواء
بالإتصال بالخط الساخن 15301او الموقع
الإلكترونى الخاص بالهيئة.
مايو 2024
اسم المستحضر
رقم التشغيلة
سبب التحذير
الإجراءات
التصحيحية
نصائح
للمستهلكين
منشور
سحب
الشركة المنتجة
هذا التنبية خاص بالتشغيلات الواردة في المنشور فقط ولا ينطبق
على تداول المستحضر بشكل عامOriginal language: ar
- Texte de l’avis en anglais
- Recall, halt of circulation and seizure. Novoral mouth refreshner spray, batch 22218b, made by Smartec for Medical and Cosmetic Preparations on behalf of Medexir Pharma, because a finding of non-conformity has been issued for the stated batch by the Egyptian Drug Authority laboratories.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- Superseded by
- Not superseded.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
- 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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 31e99ebc3e4779c8b6095d45066555793645fc077940a6781fab55c0cd462bd7SHA-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 20:41:30 UTC
Cite this record
Drug Eye Africa (2024). DEA-EG-2024-0030: Novoral Mouth Refreshner Spray — Rappel, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2024/dea-eg-2024-0030Version 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.