Xapimant

Medicinal product

(Invented) name

Xapimant

Active substance (s)

Memantino hidrochloridas

Strength

10 mg/ml

Pharmaceutical form

geriamieji lašai (tirpalas)

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N06DX01, Memantine

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2013-06-27

Date of renewal

Documents

3334_1_53 Xapimant RPP 160115.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2682/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename tirpalo mililitre yra	1 ml
Memantino hidrochloridas	10 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
52511	66434	1066434	buteliukas	20 ml ir geriamasis švirkštas N1		Receptinis	LT/1/13/3334/051	Netiekiama	-	-	No	-	-
56629	70729	1070729	buteliukas	50 ml ir geriamasis švirkštas N1		Receptinis	LT/1/13/3334/052	Netiekiama	-	-	No	-	-
56630	70730	1070730	buteliukas	100 ml ir geriamasis švirkštas N1		Receptinis	LT/1/13/3334/053	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-04-06	Išregistruotas
2013-06-27	Registruotas