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Product class:
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Medicinal product with marketing authorization
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Medicinal product class:
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Human medicine
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Name of medicinal product:
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BAQSIMI
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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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nasal powder in single-dose container
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Strength:
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3mg
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Legal status for supply*:
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Subject to medicinal prescription
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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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Indication:
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Baqsimi is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children
aged 4 years and over with diabetes mellitus.
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Safety features:
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Yes
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Marketing authorization holder:
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Eli Lilly Nederland B.V.
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Marketing authorization number:
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EU/1/19/1406
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Marketing authorization issued on:
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December 16, 2019
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Marketing authorization expires on:
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December 18, 2024
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Marketing authorization procedure type:
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Centralised
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Assessment report:
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Package code
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Name of medicinal product
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Dosage form
|
Package
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Legal status
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Reimbursements
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Reference price
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Last imported
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PƤritolumaa
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Additional information
|
|
1809176
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BAQSIMI
|
nasal powder in single-dose container
|
3mg 1TK
|
Prescription
|
|
|
|
|
|
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1809187
|
BAQSIMI
|
nasal powder in single-dose container
|
3mg 2TK
|
Prescription
|
|
|
|
|
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Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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