Duodopa

Medicinal product

(Invented) name

Duodopa

Active substance (s)

Levodopa/Karbidopa

Strength

20 mg/5 mg/ml

Pharmaceutical form

žarnyno gelis

Route (s) of administration

vartoti į žarnyną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N04BA02, Levodopa and decarboxylase inhibitor

Marketing authorisation holder

AbbVie SIA, Latvija

Date of authorisation

2005-11-10

Date of renewal

2012-05-28

Documents

0331 Duodopa zarnyno gelis II PL 2024 05 24.docx

0331 Pakuotės lapelis 2024 05 24.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/0415/001/E/002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml gelio yra	1 ml
Levodopa	20 mg
Karbidopa	5 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
17183	21102	1021102	kasetė	100 ml N7		Receptinis	LT/1/05/0331/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-05-28	Perregistruotas
2005-11-10	Registruotas