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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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1841813
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Name of medicinal product:
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OGLUO
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Active substances:
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ATC code:
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H04AA01
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Dosage form:
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solution for injection in pre-filled pen
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Route of administration:
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intramuscular use
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Strengh:
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0,5mg 0.1ml
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Amount in package:
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0.1ml 1TK
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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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Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged
2 years and over with diabetes mellitus.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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Package information leaflet (PIL):
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EST
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Labelling:
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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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Tetris Pharma B.V.
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Marketing authorization number:
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EU/1/20/1523
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Marketing authorization issued on:
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February 11, 2021
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Marketing authorization expires on:
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February 17, 2026
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Marketing authorization procedure type:
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Centralised
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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 26, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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