Adtralza

Medicinal product

(Invented) name

Adtralza

Active substance (s)

Tralokinumabas

Strength

150 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D11AH07, tralokinumab

Marketing authorisation holder

LEO Pharma A/S, Danija

Date of authorisation

2021-06-17

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled syringe	1 ml
Tralokinumabas	150 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
106741	92843	1092843	užpildytas švirkštas	N2		Receptinis	EU/1/21/1554/001	Netiekiama	-	-	No	-	-
106742	92844	1092844	užpildytas švirkštas	N4 (2×2)		Receptinis	EU/1/21/1554/002	Netiekiama	-	-	No	-	-
106743	92845	1092845	užpildytas švirkštas	N12 (6×2)		Receptinis	EU/1/21/1554/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-06-17	Registruotas