Adtralza

Medicinal product

(Invented) name

Adtralza

Active substance (s)

Tralokinumabas

Strength

300 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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 pen	2 ml
Tralokinumabas	300 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
111703	97816	1097816	užpildytas švirkštiklis	N2		Receptinis	EU/1/21/1554/004	Netiekiama	-	-	No	-	-
111704	97817	1097817	užpildytas švirkštiklis	N6 (3×2)		Receptinis	EU/1/21/1554/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-06-17	Registruotas