Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: ALK-Abello A/S, Boge Alle 6-8, DK-2970 Horsholm, Denmark
Itulazax 12SQ-Bet Oral Lyophilisate.
| Pharmaceutical Form |
|---|
|
Oral lyophilisate. White to off-white freeze-dried debossed oral lyophilisate. |
Standardised allergen extract of pollen from white birch (Betula verrucosa) 12 SQ-Bet* per oral lyophilisate.
For the full list of excipients, see section 6.1.
* [SQ-Bet is the dose unit for ITULAZAX. SQ is a method for standardisation on biological potency, major allergen content and complexity of the allergen extract. Bet is an abbreviation for Betula.]
| List of Excipients |
|---|
|
Gelatine (fish source) |
Aluminium/aluminium blister cards in outer carton. Each blister card contains 10 oral lyophilisates.
Pack sizes: 30 and 90.
Not all pack sizes may be marketed.
ALK-Abello A/S, Boge Alle 6-8, DK-2970 Horsholm, Denmark
PA1255/007/001
Date of first authorisation: 13th September 2019
| Drug | Countries | |
|---|---|---|
| ITULAZAX | Finland, Croatia, Ireland, Poland, Romania, United Kingdom |
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