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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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1722912
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Name of medicinal product:
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SEPTOLETE OMNI LEMON & ELDERFLOWER
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Active substances:
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ATC code:
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R02AA82
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Dosage form:
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lozenge
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Route of administration:
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oropharyngeal use
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Strengh:
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3mg+1mg
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Amount in package:
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40TK
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Legal status for supply*:
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Not 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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lemon and elder flower is indicated in adults, adolescents and children over 6 years of age for anti-inflammatory, analgesic and antiseptic treatment of irritations in the throat, mouth and gums, in gingivitis and pharyngitis.
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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 June 30, 2023)
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Package information leaflet (PIL):
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EST (last updated June 30, 2023)
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Translation of package information leaflet into Russian:
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RUS (last updated July 24, 2018)
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Translation of package information leaflet into English:
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ENG (last updated July 24, 2018)
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Labelling:
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(last updated July 24, 2018)
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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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KRKA d.d. Novo mesto
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Marketing authorization number:
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952817
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Marketing authorization issued on:
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October 11, 2017
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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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Decentralised
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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:
June 30, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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