betula verrucosa (Itulazax)

in the absence of a submission from the holder of the marketing authorisation:

standardised allergen extract of pollen from white birch betula verrucosa (Itulazax 12 SQ-Bet®) is not recommended for use within NHSScotland.

Indication under review: In adult patients for the treatment of moderate-to-severe allergic rhinitis and/or conjunctivitis induced by pollen from the birch homologous group. ITULAZAX is indicated in patients with a clinical history of symptoms despite use of symptom-relieving medication and a positive test of sensitisation to a member of the birch homologous group (skin prick test and/or specific IgE).

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.