Daivobet

Medicinal product

(Invented) name

Daivobet

Active substance (s)

Kalcipotriolis/Betametazonas

Strength

50 µg/0,5 mg/g

Pharmaceutical form

tepalas

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

2002-08-28

Date of renewal

2011-11-22

Documents

2709 Daivobet tepalas PL 2022 11 15, VRA_20332.docx

2709 Pakuotės lapelis tepalas 2022 11 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

DK/H/0279/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 g tepalo 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
50152	64028	1064028	tūbelė	3 g N1		Receptinis	LT/1/02/2709/001	Netiekiama	-	-	No	-	-
4870	10200	1010200	tūbelė	15 g N1		Receptinis	LT/1/02/2709/002	Netiekiama	-	-	No	-	-
4871	4143	1004143	tūbelė	30 g N1		Receptinis	LT/1/02/2709/003	Tiekiama	-	-	No	-	-	Download
4872	10201	1010201	tūbelė	60 g N1		Receptinis	LT/1/02/2709/004	Netiekiama	-	-	No	-	-
50153	64029	1064029	tūbelė	100 g N1		Receptinis	LT/1/02/2709/005	Netiekiama	-	-	No	-	-
50154	64030	1064030	tūbelė	120 g N1		Receptinis	LT/1/02/2709/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-11-22	Perregistruotas
2002-08-28	Registruotas