Protopic

Medicinal product

(Invented) name

Protopic

Active substance (s)

Takrolimuzas

Strength

0,3 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

LEO Pharma A/S, Danija

Date of authorisation

2002-02-28

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

1 g tepalo yra	1 g
Takrolimuzas	0,3 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
27939	30480	1030480	tūbelė	30 g N1		Receptinis	EU/1/02/201/001	Tiekiama	-	-	No	-	-
27940	30481	1030481	tūbelė	60 g N1		Receptinis	EU/1/02/201/002	Netiekiama	-	-	No	-	-
27941	30482	1030482	tūbelė	10 g N1		Receptinis	EU/1/02/201/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-02-28	Registruotas