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 PCS PZ 2025 12 18, rastas 2581.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
119975	106081	1106081	tūbelė	5 g N1		Receptinis	LT/1/07/0930/002	Netiekiama	-	-	No	-	-
119976	106082	1106082	tūbelė	30 g N1		Receptinis	LT/1/07/0930/003	Netiekiama	-	-	No	-	-
119977	106083	1106083	tūbelė	60 g N1		Receptinis	LT/1/07/0930/004	Netiekiama	-	-	No	-	-
119978	106084	1106084	tūbelė	100 g N1		Receptinis	LT/1/07/0930/005	Netiekiama	-	-	No	-	-

Stadijos

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