VITRAKVI

Medicinal product

(Invented) name

VITRAKVI

Active substance (s)

Larotrektinibas

Strength

20 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EX12, Larotrectinib

Marketing authorisation holder

Bayer AG, Vokietija

Date of authorisation

2019-09-19

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

Oral solution	1 ml
Larotrektinibas	20 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
102397	88497	1088497	buteliukas	100 ml N1		Receptinis	EU/1/19/1385/003	Netiekiama	-	-	No	-	-
106522	92623	1092623	buteliukas	50 ml N2		Receptinis	EU/1/19/1385/004	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-09-19	Registruotas