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Home Industry News GSK gains EU approval for Combivir

GSK gains EU approval for Combivir

7th December 2007

GlaxoSmithKline (GSK) has announced that it has gained approval from the European commission for a new indication of its HIV fixed-dose combination medicine Combivir for use in children and infants.

Until now, Combivir had only been administered for use in adults and children over 12 years of age but a shift to new weight-based prescribing has enabled Combivir to be used in younger children.

The European Union also approved new scored-tablet formations of Combivir, Epivir and Ziagen for use in children weighing more than 14kg.

GSK has stated that the approved tablet formations mark a success in its ongoing efforts to fight HIV/Aids in children as they are easier to administer and store, especially in developing countries.

JP Garnier, chief executive officer GlaxoSmithKline, highlighted that while liquid formulations of their drugs were made available to children “at a not-for-profit price to the world’s poorest countries”, there were still problems of accessibility.

“We hope that the scored-tablets, when available, will improve the treatment of children living with this devastating disease,” he said.

GSK has also confirmed this week that it fully supports the World Health Organisation’s new initiative to ‘make medicines child size’ which stresses the need to make medicines better tailored to children.

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