AKTIPROL

Medicinal product

(Invented) name

AKTIPROL

Active substance (s)

Amisulpridas

Strength

400 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 PCS PL 2025 04 27.docx

3735 Pakuotės lapelis 2025 04 27.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2386/004/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Amisulpridas	400 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
58874	73091	1073091	lizdinė plokštelė	N30		Receptinis	LT/1/15/3735/007	Netiekiama	2025-05-21	2026-12-31	No	-	-	Download
62452	76860	1076860	lizdinė plokštelė	N60		Receptinis	LT/1/15/3735/008	Netiekiama	-	-	No	-	-
62453	76861	1076861	lizdinė plokštelė	N90		Receptinis	LT/1/15/3735/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-01-24	Perregistruotas
2015-06-16	Registruotas