Calquence

Medicinal product

(Invented) name

Calquence

Active substance (s)

Akalabrutinibas

Strength

100 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)

L01EL02, acalabrutinib

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2020-11-05

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

Film-coated tablet	1 vnt.
Akalabrutinibas	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
110440	96550	1096550	lizdinė plokštelė	N56		Receptinis	EU/1/20/1479/003	Netiekiama	-	-	No	-	-
110441	96551	1096551	lizdinė plokštelė	N60		Receptinis	EU/1/20/1479/004	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-11-05	Registruotas