Draft guidance consultation
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2 Information about bulevirtide
Marketing authorisation indication
2.1 Bulevirtide (Hepcludex, Gilead) has a conditional marketing authorisation 'for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV RNA positive adult patients with compensated liver disease'.
Dosage in the marketing authorisation
2.2 The dosage schedule is available in the summary of product characteristics for bulevirtide.
Price
2.3 The list price of bulevirtide is currently confidential. The company has a commercial arrangement, which would have applied if the technology had been recommended.
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