ACARIZAX Oral lyophilisate Ref.[50644] Active ingredients:

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: ALK-Abelló A/S, Bøge Alle 6-8, DK-2970 Hørsholm, Denmark

Product name and form

ACARIZAX 12 SQ-HDM oral lyophilisate.

Pharmaceutical Form

Oral lyophilisate.

White to off-white circular freeze-dried debossed oral lyophilisate.

Qualitative and quantitative composition

Standardised allergen extract from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae 12 SQ-HDM* per oral lyophilisate.

For a full list of excipients, see section 6.1.

* [SQ-HDM is the dose unit for ACARIZAX. SQ is a method for standardisation on biological potency, major allergen content and complexity of the allergen extract. HDM is an abbreviation for house dust mite].

List of Excipients

Gelatine (fish source)
Mannitol
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

Aluminium/aluminium blister cards in outer carton. Each blister card contains 10 oral lyophilisates.

Pack sizes: 30 and 90.

Marketing authorization holder

ALK-Abelló A/S, Bøge Alle 6-8, DK-2970 Hørsholm, Denmark

Marketing authorization dates and numbers

PL10085/0058

17/5/2021

Drugs

Drug Countries
ACARIZAX Austria, Canada, Finland, France, Hong Kong, Croatia, Ireland, Israel, Netherlands, New Zealand, Poland, Romania, Turkey

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