Elidel

Medicinal product

(Invented) name

Elidel

Active substance (s)

Pimekrolimuzas

Strength

10 mg/g

Pharmaceutical form

kremas

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D11AH02, Pimecrolimus

Marketing authorisation holder

Viatris Healthcare Limited, Airija

Date of authorisation

2003-07-02

Date of renewal

2013-09-24

Documents

0930 Pakuotės lapelis 2024 08 22.docx

0930 Elidel kremas PL 2024 08 22, VRA_15893.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/0339/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 g kremo yra	1 g
Pimekrolimuzas	10 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
8074	4326	1004326	tūbelė	15 g N1		Receptinis	LT/1/07/0930/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2013-09-24	Perregistruotas
2003-07-02	Registruotas