AKTIPROL

Medicinal product

(Invented) name

AKTIPROL

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

Medochemie Ltd., Kipras

Date of authorisation

2015-06-16

Date of renewal

2020-01-24

Documents

3735 AKTIPROL II PL 2025 01 08.docx

3735 Pakuotės lapelis 2025 01 08.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2386/001/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
60878	75184	1075184	lizdinė plokštelė	N30		Receptinis	LT/1/15/3735/001	Netiekiama	-	-	No	-	-
62448	76856	1076856	lizdinė plokštelė	N60		Receptinis	LT/1/15/3735/002	Netiekiama	-	-	No	-	-	Download
62449	76857	1076857	lizdinė plokštelė	N90		Receptinis	LT/1/15/3735/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-30	Išregistruotas
2020-01-24	Perregistruotas
2015-06-16	Registruotas