GIOTRIF

Medicinal product

(Invented) name

GIOTRIF

Active substance (s)

Afatinibas

Strength

40 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)

L01EB03, afatinib

Marketing authorisation holder

Boehringer Ingelheim International GmbH, Vokietija

Date of authorisation

2013-09-25

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.
Afatinibas	40 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
57409	71524	1071524	dalomoji lizdinė plokštelė	N7x1		Receptinis	EU/1/13/879/007	Netiekiama	-	-	No	-	-
57410	71525	1071525	dalomoji lizdinė plokštelė	N14x1		Receptinis	EU/1/13/879/008	Netiekiama	-	-	No	-	-
57411	71526	1071526	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/13/879/009	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-09-25	Registruotas