BRUKINSA

Medicinal product

(Invented) name

BRUKINSA

Active substance (s)

Zanubrutinibas

Strength

160 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EL03, zanubrutinib

Marketing authorisation holder

BeOne Medicines Ireland Limited, Airija

Date of authorisation

2021-11-22

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

Kapsulėje yra:	1 vnt.
Zanubrutinibas	160 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
118606	104710	1104710	buteliukas	N60		Receptinis	EU/1/21/1576/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-22	Registruotas