Draft guidance consultation
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2 Information about etranacogene dezaparvovec
Marketing authorisation indication
2.1 Etranacogene dezaparvovec (Hemgenix, CSL Behring) has a conditional marketing authorisation 'for the treatment of severe and moderately severe Haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors'.
Dosage in the marketing authorisation
2.2 The dosage schedule is available in the summary of product characteristics for etranacogene dezaparvovec.
Price
2.3 The list price per treatment for a single dose of etranacogene dezaparvovec is £2,600,000.
2.4 The company has a commercial arrangement, which would have applied if etranacogene dezaparvovec had been recommended.
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