Published in Cancer Weekly, September 17th, 2002
Orphan drug designation makes the product eligible for orphan drug exclusivity. If a product which has an orphan drug designation receives the first marketing approval for the indication for which it has such designation, the product will be entitled to orphan drug exclusivity.
This exclusivity means that applications to market the same product for the same use may not be approved by the European Commission, except in very limited circumstances, for a period of up to 10 years and...
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