ELITAN

Medicinal product

(Invented) name

ELITAN

Active substance (s)

Metoklopramido hidrochloridas

Strength

5 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A03FA01, Metoclopramide

Marketing authorisation holder

Medochemie Ltd., Kipras

Date of authorisation

1993-04-16

Date of renewal

2008-12-18

Documents

1378_1-3_ELITAN_5mg_ml_RPP_191220.docx

1378_1-3_Pakuotės lapelis_191220.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Metoklopramido hidrochloridas	5 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
1958	7617	1007617	ampulė	2 ml, N5		Receptinis	LT/1/93/1378/001	Netiekiama	-	-	No	-	-
7523	12467	1012467	ampulė	2 ml, N10		Receptinis	LT/1/93/1378/002	Tiekiama	-	-	No	-	-	Download
7524	12468	1012468	ampulė	2 ml, N100		Receptinis	LT/1/93/1378/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-12-18	Perregistruotas
1993-04-16	Registruotas