Enstilar

Medicinal product

(Invented) name

Enstilar

Active substance (s)

Kalcipotriolis/Betametazonas

Strength

50 µg/0,5 mg/g

Pharmaceutical form

odos putos

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

2016-04-29

Date of renewal

2021-10-26

Documents

3906 Enstilar PL 2024 12 05.docx

3906 Pakuotės lapelis 2024 12 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/2478/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 grame 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
61521	75861	1075861	slėginė talpyklė	60 g N1		Receptinis	LT/1/16/3906/001	Tiekiama	-	-	No	-	-	Download
65556	80064	1080064	slėginė talpyklė	60 g N2		Receptinis	LT/1/16/3906/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-10-26	Perregistruotas
2016-04-29	Registruotas