Tevimbra

Medicinal product

(Invented) name

Tevimbra

Active substance (s)

Tislelizumabas

Strength

100 mg

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)

L01FF09, tislelizumab

Marketing authorisation holder

BeiGene Ireland Limited, Airija

Date of authorisation

2023-09-15

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

Concentrate for solution for infusion	10 ml
Tislelizumabas	100 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
111687	97800	1097800	flakonas	10 ml N1		Receptinis	EU/1/23/1758/001	Netiekiama	-	-	No	-	-
111688	97801	1097801	flakonas	10 ml N2 (2×1)		Receptinis	EU/1/23/1758/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-15	Registruotas