Tremelimumab AstraZeneca

Medicinal product

(Invented) name

Tremelimumab AstraZeneca

Active substance (s)

Tremelimumabas

Strength

20 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FX20, tremelimumab

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2023-02-20

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	1 ml
Tremelimumabas	20 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
110438	96548	1096548	flakonas	1,25 ml N1		Receptinis	EU/1/22/1712/001	Netiekiama	-	-	No	-	-
110439	96549	1096549	flakonas	15 ml N1		Receptinis	EU/1/22/1712/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-01	Išregistruotas
2023-02-20	Registruotas