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In a relief to Glenmark Pharmaceuticals Ltd. and other pharmaceutical companies, the Delhi High Court on Thursday ruled that the government's restriction on the manufacture, sale, and distribution of all fixed-dose combinations of chlorpheniramine maleate and phenylephrine hydrochloride for children under four years of age will apply prospectively. The notification, issued by the government on Apr. 15, requires manufacturers to include a warning stating "fixed-dose combination shall not be used in children below four years of age" on the drug's label, package insert, and promotional materials.
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