Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ADTRALZA
Active substances:
Tralokinumab
Estonian, English, Latin
ATC code: D11AH07
Dosage form: solution for injection in pre-filled syringe
Strength: 150mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Adtralza is indicated for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy.
Safety features: Yes
: 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 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 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1852310  ADTRALZA  solution for injection in pre-filled syringe  150mg 1ml 1ml 2TK  Prescription           
1852321  ADTRALZA  solution for injection in pre-filled syringe  150mg 1ml 1ml 4TK  Prescription           
1852332  ADTRALZA  solution for injection in pre-filled syringe  150mg 1ml 1ml 12TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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