Healthy Skepticism Library item: 14544

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Publication type: Journal Article

European Medicines Agency approves POM-to-P orlistat switch
The Pharmaceutical Journal 2008 Oct 30; 281:(495):
http://www.pjonline.com/news/european_medicines_agency_approves_pomtop_orlistat_switch

Full text:

Orlistat 60mg (Alli) has been recommended as a non-prescription product by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

The prescription-only to non-prescription switch will be the first time the status of a medicine has been changed centrally, allowing approval of Alli in all 27 EU member states by the end of 2008. A spokeswoman for GlaxoSmithKline, the company behind the switch application, said there were plans to launch Alli in the UK in 2009.

Orlistat 60mg will be indicated for weight loss in adults with a body mass index of 28 or more, and should be taken in conjunction with a reduced calorie, lower-fat diet.

The spokeswoman added: “If successful, GSK will provide comprehensive training and education for pharmacy staff so that they are able to advise customers on Alli.”

GSK completed an agreement with Roche (which markets prescription orlistat 120mg) in February 2007 that enabled the company to seek regulatory approval for orlistat 60mg as the first non-prescription weight loss product to be licensed in Europe.

The recommendation has now been sent to the European Commission for ratification of the decision.