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French pharmaceutical giant Sanofi confirmed on Monday that it has been placed under formal investigation for involuntary homicide over the anti-epileptic drug sodium valproate.

The medicine, marketed in France as Depakine, has been linked to birth defects and developmental disorders when taken by pregnant women.

The company said it was already under investigation on charges of aggravated deceit and causing involuntary injuries. It said it was appealing to a prosecution appeals chamber.

"Sanofi Aventis France has respected its obligations to provide information and contests the basis for these proceedings," it said in an emailed statement.

A 2017 study by French authorities estimated that between 2,150 and 4,100 children were born with severe birth defects after being exposed to sodium valproate during pregnancy between 1967 and 2016.

Last month, an administrative court ordered the French government to pay almost half a million euros (more than half a million dollars) compensation to three families whose children suffered grave disabilities linked to the drug.

On Friday, Sanofi and British pharmaceutical company GlaxoSmithKline said they were in "advanced discussions" with the European Union to supply up to 300 million doses of a vaccine for Covid-19 that they are currently developing.