Xamiol

Medicinal product

(Invented) name

Xamiol

Active substance (s)

Kalcipotriolis/Betametazonas

Strength

50 µg/0,5 mg/g

Pharmaceutical form

gelis

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D05AX52, Calcipotriol, combinations

Marketing authorisation holder

LEO Pharma A/S, Danija

Date of authorisation

2009-11-04

Date of renewal

2013-09-24

Documents

1772_1_4 Pakuotės lapelis 191129.docx

1772_1_4 Xamiol gelis PCS PL 191129.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

DK/H/1405/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 g gelio yra	1 g
Kalcipotriolis	50 µg
Betametazonas	0,5 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
34613	36955	1036955	buteliukas	15 g N1		Receptinis	LT/1/09/1772/001	Netiekiama	-	-	No	-	-
37956	5569	1005569	buteliukas	30 g N1		Receptinis	LT/1/09/1772/002	Netiekiama	-	-	No	-	-	Download
37957	51598	1051598	buteliukas	60 g N1		Receptinis	LT/1/09/1772/003	Netiekiama	-	-	No	-	-
37958	51599	1051599	buteliukas	60 g N2		Receptinis	LT/1/09/1772/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-29	Išregistruotas
2013-09-24	Perregistruotas
2009-11-04	Registruotas