Duodopa

Medicinal product

(Invented) name

Duodopa

Active substance (s)

Foslevodopa/Foskarbidopa

Strength

240 mg/12 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N04BA07, foslevodopa and decarboxylase inhibitor

Marketing authorisation holder

AbbVie SIA, Latvija

Date of authorisation

2023-01-20

Date of renewal

Documents

5106 Duodopa inf PCS PL 2023 11 09.docx

5106 Pakuotės lapelis 2023 11 09.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/0415/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Foslevodopa	240 mg
Foskarbidopa	12 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
110239	96348	1096348	flakonas	10 ml N7		Receptinis	LT/1/23/5106/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-01-20	Registruotas