Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1818468
|
Name of medicinal product:
|
DUPIXENT
|
Active substances:
|
|
ATC code:
|
D11AH05
|
Dosage form:
|
solution for injection in pre-filled pen
|
Route of administration:
|
subcutaneous use
|
Strengh:
|
300mg 2ml
|
Amount in package:
|
2ml 1TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
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
Adults and adolescents
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 inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Children 6 to 11 years of age
Dupixent is indicated in children 6 to 11 years old 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 medium to high dose
inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.
Chronic rhinosinusitis with nasal polyposis (CRSwNP)
Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults
with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide
adequate disease control.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Sanofi Winthrop Industrie
|
Marketing authorization number:
|
EU/1/17/1229
|
Marketing authorization issued on:
|
September 26, 2017
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
January 30, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere