TAGRISSO

Medicinal product

(Invented) name

TAGRISSO

Active substance (s)

Osimertinibas

Strength

80 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)

L01EB04, osimertinib

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2016-02-02

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.
Osimertinibas	80 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
65157	79654	1079654	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/16/1086/002	Tiekiama	-	-	No	-	-
66758	81295	1081295	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/16/1086/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-02-02	Registruotas