Cabemet

Medicinal product

(Invented) name

Cabemet

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

Sandoz d.d., Slovėnija

Date of authorisation

2016-01-26

Date of renewal

2020-10-23

Documents

3870 Pakuotės lapelis 2024 12 11.docx

3870 Cabemet II PL 2024 12 11.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/3441/001/DC

Marketing authorisation procedure

Decentralizuota 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
61265	75580	1075580	tūbelė	15 g N1		Receptinis	LT/1/16/3870/001	Netiekiama	-	-	No	-	-
64809	79299	1079299	tūbelė	30 g N1		Receptinis	LT/1/16/3870/002	Tiekiama	-	-	No	-	-	Download
64810	79300	1079300	tūbelė	60 g N1		Receptinis	LT/1/16/3870/003	Netiekiama	-	-	No	-	-
64811	79301	1079301	tūbelė	120 g N1		Receptinis	LT/1/16/3870/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-10-23	Perregistruotas
2016-01-26	Registruotas