Egyptian Drug Authority

 
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Advisory, Warnings and Recall Notices

  CAPA Head's Memos (63) for recalling Mucogel Suspension

Ministerial Decree Number 458 for banning Nimesulide and Memo for execution

H.E. the Minister of Health has ordered withdrawal of all pediatric preparation containing Nimesulide from Egyptian markets after cancelling all marketing authorizations.For instance, the CAPA technical committee had issued a recommendation on October 22nd, 2009 to cancel the marketing authorization for the suspension form of Nimesulide due to its serious adverse actions on children under 12 years old. Moreover, the technical committee requested reviewing of registration of all Nimesulide dosage forms (tablets, suppository, topical gel, topical cream and sachets) and adding more warning statements on patient inserts.The prohibited Nimesulide Suspension preparations were traded under the following commercial names:

Product Commercial Name Manufacturer
Sulide 1% SuspensionHikma Pharmaceuticals
Nilsid 1% SuspensionPharopharma
Nimalox 50 mg/5 mL Suspension         Sigma
Mesulan SuspensionMepaco / Arab Co. for Gelatin Products


  Ministerial Decree Number 458 for banning Nimesulide and Memo for execution


CAPA alert against Hepatoguard

CAPA president issued a memo against the appearance of a suspected product under name of "Hepatoguard" (see photo). This product is of unknown origin. In addition, registration number printed on the box is for another product. Insert inside the box claims therapeutic benefits, therefore, it might be a dangerous product. CAPA warns against trade or administration of this product.

  CAPA President’ Memo (69)


EDA alerts against Original Baraka

Original Baraka Capsule™ is a name of a product that is produced by M.T. Pharma promising cure of patients with Hepatitis C without side effects.

Such therapeutic claims are not supported by clinical or scientific evidences. Original Baraka Capsule™ had EXPIRED registration (Expiry Date 29/3/2007) as DIETARY SUPPLEMENT without any particular therapeutic benefit. CAPA Scientific and Ethics Committee had made disapproval decision against marketing of Original Baraka Capsule™ in Egypt on April 23, 2009 due to false therapeutic claims. In addition, CAPA president issued withdrawal orders against Original Baraka Capsule™ on 30 / 1 / 2008 and on 2/3/2009.
  CAPA president issued withdrawal orders against Original Baraka Capsule™
  Original Baraka Decisions

Withdrawal Of Nitrofurazone

EDA Technical Committee decides to withdraw all registered & Under registration drugs containing Nitrofurazone due to safety Considerations (carcinogenic)

  Withdrawal Of Nitrofurazone.


Withdrawal Of Ramelton

EDA Technical Committee decides to withdraw of all Under registration drugs containing Ramelton due to safety Considerations because it causes change in ECG and it’s not safe in elderly patients

  Withdrawal Of Ramelton.

 
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