paxeladine

Medicinal product

(Invented) name

paxeladine

Active substance (s)

Okseladino-vandenilio citratas

Strength

2 mg/ml

Pharmaceutical form

sirupas

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R05DB09, Oxeladin

Marketing authorisation holder

IPSEN Consumer HealthCare, Prancūzija

Date of authorisation

1995-02-15

Date of renewal

2009-04-24

Documents

0019 Pakuotės lapelis 2021 11 11, VRA_23003.docx

0019 paxeladine PL 2021 11 11, VRA_23003.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml sirupo yra	1 ml
Okseladino-vandenilio citratas	2 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
1378	7130	1007130	buteliukas	125 ml ir matavimo šaukštas arba matavimo taurelė, N1		Nereceptinis	LT/1/95/0019/002	Netiekiama	-	-	No	-	-
107520	93625	1093625	buteliukas	100 ml ir matavimo šaukštas arba matavimo taurelė, N1		Nereceptinis	LT/1/95/0019/003	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-04-24	Perregistruotas
1995-02-15	Registruotas