Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ORALAIR 300 IR
Active substances:
Grass pollen allergen extract
Estonian, English, Latin
ATC code: V01AA02
Dosage form: sublingual tablet
Strength: 300IR
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated October 12, 2023)
Package information leaflet (PIL): EST  (last updated October 20, 2023)
Labelling:  (last updated October 20, 2023)
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
Marketing authorization holder: Stallergenes 
Marketing authorization number: 672910 
Marketing authorization issued on: February 3, 2010 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1415911  ORALAIR 300 IR  sublingual tablet  300IR 30TK  Prescription           
1415922  ORALAIR 300 IR  sublingual tablet  300IR 90TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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