SINEMET

Medicinal product

(Invented) name

SINEMET

Active substance (s)

Karbidopa/Levodopa

Strength

25 mg/250 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N04BA02, Levodopa and decarboxylase inhibitor

Marketing authorisation holder

N.V. Organon, Nyderlandai

Date of authorisation

1993-10-07

Date of renewal

2014-06-06

Documents

0358 Pakuotės lapelis tab 2023 10 05.docx

0358 SINEMET PCS PL 2023 10 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Karbidopa	25 mg
Levodopa	250 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
7721	3735	1003735	lizdinė plokštelė	N30		Receptinis	LT/1/93/0358/001	Netiekiama	-	-	No	-	-
7722	1763	1001763	lizdinė plokštelė	N100		Receptinis	LT/1/93/0358/002	Tiekiama	2025-02-25	-	No	-	-	Download

Stadijos

Data	Stadija
2014-06-06	Perregistruotas
1993-10-07	Registruotas