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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1415911
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Name of medicinal product:
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ORALAIR 300 IR
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Active substances:
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ATC code:
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V01AA02
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Dosage form:
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sublingual tablet
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Route of administration:
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oromucosal use
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Strengh:
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300IR
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Amount in package:
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30TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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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).
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Safety features:
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No
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Summary of product characteristics (SPC):
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 (last updated October 12, 2023)
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Package information leaflet (PIL):
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EST (last updated October 20, 2023)
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Labelling:
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(last updated October 20, 2023)
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Stallergenes
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Marketing authorization number:
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672910
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Marketing authorization issued on:
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February 3, 2010
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Mutual recognition
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Reference price:
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Under reference price:
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Reference price of daily dose:
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Entry/Changing date:
October 20, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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