On 30 May 2008, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product ramelteon 4 mg and 8 mg tablets intended for the treatment of primary insomnia in adult patients.
The company that applied for authorisation is Takeda Global Research and Development Centre (Europe) Ltd. They may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
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