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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1796171
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Name of medicinal product:
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DUPIXENT
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Active substances:
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ATC code:
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D11AH05
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Dosage form:
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solution for injection in pre-filled syringe
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Route of administration:
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subcutaneous use
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Strengh:
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200mg 1.14ml
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Amount in package:
|
1.14ml 1TK
|
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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Atopic Dermatitis
Adults and adolescents
Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and
adolescents 12 years and older who are candidates for systemic therapy.
Children 6 to 11 years of age
Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 to 11 years old who are
candidates for systemic therapy.
Asthma
Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for
severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised
fraction of exhaled nitric oxide (FeNO), see section 5.1, who are inadequately controlled with high
dose ICS plus another medicinal product for maintenance treatment.
|
Safety features:
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Yes
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Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
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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Sanofi Winthrop Industrie
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Marketing authorization number:
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EU/1/17/1229
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Marketing authorization issued on:
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September 26, 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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Centralised
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Reference price:
|
|
Under reference price:
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|
Reference price of daily dose:
|
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Entry/Changing date:
January 12, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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