Daivobet

Medicinal product

(Invented) name

Daivobet

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

2012-02-14

Date of renewal

2016-01-26

Documents

2709 Pakuotės lapelis gelis 2022 11 15.docx

2709 Daivobet gelis PL 2022 11 15, VRA_20332.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

DK/H/0279/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Viename grame 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
47557	61376	1061376	buteliukas	15 g N1		Receptinis	LT/1/02/2709/007	Netiekiama	-	-	No	-	-
51191	65083	1065083	buteliukas	30 g N1		Receptinis	LT/1/02/2709/008	Tiekiama	-	-	No	-	-	Download
51192	65084	1065084	buteliukas	60 g N1		Receptinis	LT/1/02/2709/009	Netiekiama	-	-	No	-	-
51193	65085	1065085	buteliukas	60 g N2		Receptinis	LT/1/02/2709/010	Netiekiama	-	-	No	-	-
57242	71357	1071357	buteliukas	60 g N3		Receptinis	LT/1/02/2709/011	Netiekiama	-	-	No	-	-
60196	74468	1074468	aplikatorius	60 g N1		Receptinis	LT/1/02/2709/012	Netiekiama	-	-	No	-	-
60197	74469	1074469	aplikatorius	60 g N2		Receptinis	LT/1/02/2709/013	Netiekiama	-	-	No	-	-
64764	79253	1079253	buteliukas	80 g N1		Receptinis	LT/1/02/2709/014	Netiekiama	-	-	No	-	-
64765	79254	1079254	buteliukas	80 g N2		Receptinis	LT/1/02/2709/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-01-26	Perregistruotas
2012-02-14	Registruotas