Calquence

Medicinal product

(Invented) name

Calquence

Active substance (s)

Akalabrutinibas

Strength

100 mg

Pharmaceutical form

kietosios kapsulės

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

Hard capsule	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
105209	91311	1091311	lizdinė plokštelė	N56		Receptinis	EU/1/20/1479/001	Netiekiama	-	-	No	-	-
105210	91312	1091312	lizdinė plokštelė	N60		Receptinis	EU/1/20/1479/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-11-05	Registruotas