AMISAN

Medicinal product

(Invented) name

AMISAN

Active substance (s)

Amisulpridas

Strength

50 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05AL05, Amisulpride

Marketing authorisation holder

PRO. MED. CS Praha a.s., Čekija

Date of authorisation

2010-02-19

Date of renewal

2014-09-04

Documents

1867 Pakuotės lapelis 2024 09 07.docx

1867 AMISAN PCS PL 2024 09 07.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

CZ/H/0432/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Amisulpridas	50 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
29256	31756	1031756	lizdinė plokštelė	N12		Receptinis	LT/1/10/1867/001	Netiekiama	-	-	No	-	-
29257	31757	1031757	lizdinė plokštelė	N60		Receptinis	LT/1/10/1867/002	Netiekiama	-	-	No	-	-
39407	53106	1053106	lizdinė plokštelė	N600	ASPĮ	Receptinis	LT/1/10/1867/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-09-04	Perregistruotas
2010-02-19	Registruotas