Alunbrig

Medicinal product

(Invented) name

Alunbrig

Active substance (s)

Brigatinibas

Strength

30 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)

L01ED04, brigatinib

Marketing authorisation holder

Takeda Pharma A/S, Danija

Date of authorisation

2018-11-22

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

Film-coated tablet	1 vnt.
Brigatinibas	30 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
100501	86610	1086610	buteliukas	N60		Receptinis	EU/1/18/1264/001	Netiekiama	-	-	No	-	-
100502	86611	1086611	buteliukas	N120		Receptinis	EU/1/18/1264/002	Netiekiama	-	-	No	-	-
100503	86612	1086612	lizdinė plokštelė	N56		Receptinis	EU/1/18/1264/003	Netiekiama	-	-	No	-	-
100504	86613	1086613	lizdinė plokštelė	N112		Receptinis	EU/1/18/1264/004	Netiekiama	-	-	No	-	-
100947	87058	1087058	lizdinė plokštelė	N28		Receptinis	EU/1/18/1264/011	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-11-22	Registruotas