IKERVIS

Medicinal product

(Invented) name

IKERVIS

Active substance (s)

Ciklosporinas

Strength

1 mg/ml

Pharmaceutical form

akių lašai (emulsija)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

S01XA18, Ciclosporin

Marketing authorisation holder

Santen Oy, Suomija

Date of authorisation

2015-03-19

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

Eye drops, emulsion	1 ml
Ciklosporinas	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
107867	93972	1093972	buteliukas	2,5 ml N1		Receptinis	EU/1/15/990/003	Netiekiama	-	-	No	-	-
107868	93973	1093973	buteliukas	4,5 ml N1		Receptinis	EU/1/15/990/004	Netiekiama	-	-	No	-	-
107869	93974	1093974	buteliukas	7 ml N1		Receptinis	EU/1/15/990/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-03-19	Registruotas