Product class: Authorized package
Medicinal product class: For human use
Package code: 1415911
Name of medicinal product: ORALAIR 300 IR
Active substances:
Grass pollen allergen extract
Estonian, English, Latin
ATC code: V01AA02
Dosage form: sublingual tablet
Route of administration: oromucosal use
Strengh: 300IR
Amount in package: 30TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Treatment of grass pollen allergic rhinitis with or without conjunctivitis in adults, adolescents and children (above the age of 5) with clinically relevant symptoms, confirmed by a positive cutaneous test and/or a positive titre of the specific IgE to one of the grass pollen from the Pooideae grass homologous group1. 1 Pooideae (temperate) grass homologous group: Phleum pratense (Timothy grass), Anthoxanthum odoratum (Sweet vernal grass), Avena sativa (Oat), Dactylis glomerata (Orchard grass/Cocksfoot), Festuca spp. (Meadow fescue), Holcus lanatus (Velvet grass/Yorkshire fog), Hordeum vulgare (Barley), Lolium perenne (Perennial ryegrass), Poa pratensis (Kentucky bluegrass), Secale cereale (Cultivated rye), Triticum aestivum (Cultivated wheat).
Safety features: No
Summary of product characteristics (SPC):  (last updated 12 October 2023)
Package information leaflet (PIL): EST  (last updated 20 October 2023)
Labelling:  (last updated 20 October 2023)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Stallergenes 
Marketing authorization number: 672910 
Marketing authorization issued on: 03 February 2010 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 20 October 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription