Register of
Medicinal Products
Human medicines
Veterinary medicines
Medical nutritions
User
Listings
Data download
Veterinary medicines
Search for medicinal products
Search for packages
ATC tree
Print
ADTRALZA
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1852310
Name of medicinal product:
ADTRALZA
Active substances:
Tralokinumab
Estonian
,
English
,
Latin
ATC code:
D11AH07
Dosage form:
solution for injection in pre-filled syringe
Route of administration:
subcutaneous use
Strengh:
150mg
Amount in package:
2TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Adtralza is indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.
Safety features:
Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL):
EST
Labelling:
Last imported to Estonia:
Never imported to Estonia
:
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
Marketing authorization
Marketing authorization holder:
LEO Pharma A/S
Marketing authorization number:
EU/1/21/1554
Marketing authorization issued on:
June 17, 2021
Marketing authorization expires on:
June 18, 2026
Marketing authorization procedure type:
Centralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: July 15, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader from
here