Neupedix

Medicinal product

(Invented) name

Neupedix

Active substance (s)

Alprostadilis

Strength

500 µg

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01EA01, Alprostadil

Marketing authorisation holder

Kevelt AS, Estija

Date of authorisation

2024-02-07

Date of renewal

Documents

5340 Pakuotės lapelis 2024 03 20.docx

5340 Neupedix PL 2024 03 20.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/1362/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Ampulėje (1 ml tirpalo) yra:	1 ml
Alprostadilis	500 µg

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
112698	98818	1098818	ampulė	1 ml N5		Receptinis	LT/1/24/5340/001	Netiekiama	-	-	No	-	-
112699	98819	1098819	ampulė	1 ml N10		Receptinis	LT/1/24/5340/002	Netiekiama	-	-	No	-	-
112700	98820	1098820	ampulė	1 ml N20		Receptinis	LT/1/24/5340/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-02-07	Registruotas