Lebsanan

Medicinal product

(Invented) name

Lebsanan

Active substance (s)

Takrolimuzas

Strength

1 mg/g

Pharmaceutical form

tepalas

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

D11AH01, Tacrolimus

Marketing authorisation holder

UAB Norameda, Lietuva

Date of authorisation

2017-12-12

Date of renewal

2022-06-09

Documents

4171 Lebsanan PCS PL 2024 05 08.docx

4171 Pakuotės lapelis 2024 05 08.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

EE/H/0297/002

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g tepalo yra	1 g
Takrolimuzas	1 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
60248	74523	1074523	tūbelė	10 g N1		Receptinis	LT/1/17/4171/001	Netiekiama	-	-	No	-	-
98531	84634	1084634	tūbelė	30 g N1		Receptinis	LT/1/17/4171/002	Tiekiama	-	-	No	-	-	Download
98532	84635	1084635	tūbelė	60 g N1		Receptinis	LT/1/17/4171/003	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2022-06-09	Perregistruotas
2017-12-12	Registruotas