Betamaks

Medicinal product

(Invented) name

Betamaks

Active substance (s)

Sulpiridas

Strength

200 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05AL01, Sulpiride

Marketing authorisation holder

AS Grindeks, Latvija

Date of authorisation

2019-04-12

Date of renewal

2022-08-23

Documents

4365_4367 Betamaks PL 2024 11 04, VRA.docx

4365_4367 Pakuotės lapelis 2024 11 04, VRA.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0288/003/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Sulpiridas	200 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
101397	87500	1087500	lizdinė plokštelė	N30		Receptinis	LT/1/19/4367/001	Netiekiama	-	-	No	-	-
112768	98888	1098888	lizdinė plokštelė	N100		Receptinis	LT/1/19/4367/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-23	Perregistruotas
2019-04-12	Registruotas