Alunbrig

Medicinal product

(Invented) name

Alunbrig

Active substance (s)

Brigatinibas+Brigatinibas

Strength

90 mg + 180 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 (90 mg)	1 vnt.
Brigatinibas	90 mg
Film-coated tablet (180 mg)	1 vnt.
Brigatinibas	180 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
100948	87059	1087059	lizdinė plokštelė	N28 (7x90 mg + 21x180 mg)	pakuotė gydymui pradėti	Receptinis	EU/1/18/1264/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-11-22	Registruotas