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
61762	76105	1076105	vienadozė talpyklė	0,3 ml N30		Receptinis	EU/1/15/990/001	Tiekiama	-	-	No	-	-
61763	76106	1076106	vienadozė talpyklė	0,3 ml N90		Receptinis	EU/1/15/990/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-03-19	Registruotas