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1 Recommendations

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2 Information about efanesoctocog alfa

Anticipated marketing authorisation indication

2.1

Efanesoctocog alfa (Altuvoct, Swedish Orphan Biovitrum) does not have a marketing authorisation in Great Britain yet. The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorisation for the medicinal product efanesoctocog alfa, intended for the treatment and prophylaxis of bleeding in people with haemophilia A (congenital factor VIII deficiency).

Dosage in the marketing authorisation

2.2

The dosage schedule will be available in the summary of product characteristics for efanesoctocog alfa.

Price

2.3

The list price per vial of 1,000 IU efanesoctocog alfa is £2,400 (£2.40 per IU). It is available as 250 IU, 500 IU, 750 IU, 1000 IU, 2000 IU, 3000 IU, 4000 IU vials.

2.4

The company has a commercial arrangement, which would have applied if the efanesoctocog alfa had been recommended.