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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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SKYTROFA
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Active substances:
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ATC code:
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H01AC09
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Dosage form:
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powder and solvent for solution for injection in cartridge
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Strength:
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5,2mg
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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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Growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient
endogenous growth hormone secretion (growth hormone deficiency [GHD]).
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Safety features:
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Yes
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 :
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This medicinal product is subject to additional monitoring. This will allow quick identification of
new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
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Marketing authorization holder:
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Ascendis Pharma Endocrinology Division A/S
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Marketing authorization number:
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EU/1/21/1607
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Marketing authorization issued on:
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January 11, 2022
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Marketing authorization expires on:
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January 17, 2027
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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
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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
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1873953
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SKYTROFA
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powder and solvent for solution for injection in cartridge
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5,2mg 4TK
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Prescription
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Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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