SINEMET

Medicinal product

(Invented) name

SINEMET

Active substance (s)

Karbidopa/Levodopa

Strength

25 mg/100 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

2001-05-16

Date of renewal

2007-10-30

Documents

0358 SINEMET PCS PL 2023 10 05.docx

0358 Pakuotės lapelis tab 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	100 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
10166	3920	1003920	lizdinė plokštelė	N30		Receptinis	LT/1/93/0358/003	Netiekiama	-	-	No	-	-
101584	87688	1087688	lizdinė plokštelė	N60		Receptinis	LT/1/93/0358/009	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2007-10-30	Perregistruotas
2001-05-16	Registruotas