Sandimmun Neoral

Medicinal product

(Invented) name

Sandimmun Neoral

Active substance (s)

Ciklosporinas

Strength

100 mg

Pharmaceutical form

minkštosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

L04AD01, Ciclosporin

Marketing authorisation holder

SIA Novartis Baltics, Latvija

Date of authorisation

1994-06-22

Date of renewal

2008-04-07

Documents

1089 Pakuotės lapelis 2024 07 15.docx

1089 Sandimmun Neoral RPP 2024 07 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/4019/004/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Ciklosporinas	100 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
9110	1739	1001739	lizdinė plokštelė	N50		Receptinis	LT/1/94/1089/003	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2008-04-07	Perregistruotas
1994-06-22	Registruotas