Nerlynx

Medicinal product

(Invented) name

Nerlynx

Active substance (s)

Neratinibas

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)

L01EH02, neratinib

Marketing authorisation holder

Pierre Fabre Medicament, Prancūzija

Date of authorisation

2018-08-31

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.
Neratinibas	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
100092	86200	1086200	buteliukas	N180		Receptinis	EU/1/18/1311/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-08-31	Registruotas