Documentary List of Main Dangerous Drugs Banned and Withdrawn in the Foreign Markets

Welcome to the Documentary List of Main Dangerous Drugs Banned and Withdrawn in the Foreign Markets. This documentary list includes:

	Registered drug products including Active Ingredients which are banned and withdrawn in Lebanon through legal "Decisions" based upon World Health Organization's alerts and other drug regulatory agencies.
	Registered drug products including Active Ingredients which are banned and withdrawn in foreign markets but not banned nor withdrawn in Lebanon.
	Unregistered drug products that are withdrawn from foreign markets and that might be available in the Lebanese market.

Withdrawal and banning of the listed drug products (Trade Names) is based on the status of its corresponding Active Ingredient. It is very important to note that sometimes a listed Drug Trade Name might not include the said Active Ingredient and therefore is not to be considered banned nor withdrawn. This occurs when the Manufacturer changed the Active Ingredient of the drug product due to the regulatory action taken by the corresponding Government (i.e. the Manufacturer modified the ingredients of the drug product without changing the Trade Name).

This documentary list does not include herbal plants or dietary supplements as they are not classified as drug products in Lebanon.

The information listed cannot be regarded as exhaustive in terms of drug products taking into consideration the absence of a centralized automated database, at this point, at the Lebanese Ministry of Public Health. Therefore, status and qualifications of drug products legally dispensed in Lebanon is not readily available. However, Tomorrow's Advice through persistence and search covered all registered drug products imported or locally manufactured, as well as unregistered drug products known to be available in the market.

The documentary list of banned and withdrawn drugs is based on many Local and International resources.

	Ministry of Public Health
	Order of Pharmacists
	Lebanese Customs
	Non Governmental Organizations

	A Consolidated List of Products Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted, or not Approved by Governments, United Nations (1997 Edition)
	Pharmaceuticals: Restrictions in Use and Availability, World Health Organization, March 2001 & April 1999
	The Pharmacological Basis of Therapeutics. Goodman & Gilman's. McGrawHill, Medical Publishing Division: New York, 2001; International Edition, Tenth Edition
	World Health Organization Website (www.who.int)
	United Nations website
	Food and Drug Administration ("FDA") Website, www.fda.gov
	The European Agency for the Evaluation of Medical Products ("EMEA") Website
	Agence Française de Securité Sanitaire des Produits de Santé ("AFSSaPS") Website
	Pharmacovigilance Website
	Health Canada On Line Website
	Medicines Control Agency ("MCA") Website
	British Journal of Clinical Pharmacology, 1998
	Australian Department of Health and Ageing Website
	General Pharmaceutical Inspectorate, Ministry of Social Affairs, Public Health and the Environment, Belgium, (www.afigp.fgov.be)
	Federal Institute for Drugs and Medical Devices, Germany

Each drug product includes the following criteria:

Trade Name including Form, Dosage, and Presentations, when available. Active Ingredient which is the ingredient that has the pharmacological effect. Manufacturer of the drug product. Therapeutic Category where drug products are pharmacologically classified as per the United Nations Publication "A Consolidated List of Products Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted, or not Approved by Governments" (1997 Edition). Status describing the legal regulatory action taken by the different Governments of the listed countries. While most of the drug products are withdrawn or banned, wordings used by the Regulatory Governments differ. The status wordings will appear as listed in the United Nations and World Health Organization's references listed above: "Withdrawn" A drug product that has been removed from the market based on either actions: "Banned" or "Prohibited" A drug product that has been withdrawn from use and/or sale nationally by order of the Legal National Authority on grounds of safety. "Voluntarily Withdrawn by Manufacturer" A drug product that has been withdrawn from use or sale by voluntary action of the Manufacturer on grounds of safety. "Suspension of Marketing Authorization" or "Suspension de Mise sur le Marché", Marketing Authorization for a certain drug product that has been temporarily or permanently withdrawn by the Legal National Authority on grounds of safety. "Suspended" Registration of a drug product that has been postponed for later evaluation by the Legal National Authority on grounds of safety. "Registration Cancelled" / "Registration Withdrawn" / "Registration Prohibited" / "Registration Not Allowed" A drug product which registration has been cancelled or withdrawn after being approved earlier by the Legal National Authority on grounds of safety. "Not Approved" A drug product which has been submitted for registration by a Manufacturer and has been rejected by the Legal National Authority on grounds of safety. Status Detail relating the Status disclosed to the trade activity of the drug products/Active Ingredients as well as any other information necessary for clarification. Reason describing the dangerous side effects associated with the Active Ingredient. Countries listing the governments that took the regulatory measures mentioned in the Status as communicated to the United Nations and the World Health Organization as well as to other International Drug Regulatory Agencies mentioned above. The United Nations and World Health Organization References present information on national regulatory decisions, and on voluntary withdrawal of products by manufacturers on grounds of safety, as reported to them by National Governments or Drug Regulatory Agencies. Some other countries, not listed, might have banned the drug product but did not communicate it to the United Nations and the World Health Organization, or the product may not have been submitted for registration. Year stating the starting date when the regulation (i.e. Status) came into force. Sources listing local and international references used to back up the information described for each Drug Product/Active Ingredient. Market Status stating the registration status at the Lebanese Ministry of Public Health and availability of the drug product in the Lebanese market: Registered and Available Registered and Not Available Not Registered and Not Available Available and Not Registered