ILOXEN

Medicinal product

(Invented) name

ILOXEN

Active substance (s)

Ibuprofenas/Pseudoefedrino hidrochloridas

Strength

200 mg/30 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R05X, Other cold preparations

Marketing authorisation holder

PharmaSwiss Česká republika s.r.o., Čekija

Date of authorisation

2016-02-15

Date of renewal

2020-04-29

Documents

3881 ILOXEN PCS PL 2025 05 09.docx

3881 Pakuotės lapelis 2025 05 09.docx

Pseudoephedrine_DHPC.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0385/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ibuprofenas	200 mg
Pseudoefedrino hidrochloridas	30 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
60168	74440	1074440	lizdinė plokštelė	N10		Nereceptinis	LT/1/16/3881/001	Netiekiama	-	-	No	-	-
65070	79567	1079567	lizdinė plokštelė	N12		Nereceptinis	LT/1/16/3881/002	Tiekiama	-	-	No	-	-	Download
65071	79568	1079568	lizdinė plokštelė	N20		Nereceptinis	LT/1/16/3881/003	Netiekiama	-	-	No	-	-
65072	79569	1079569	lizdinė plokštelė	N24		Nereceptinis	LT/1/16/3881/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-29	Perregistruotas
2016-02-15	Registruotas