Verkazia

Medicinal product

(Invented) name

Verkazia

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

2018-04-06

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
99817	85925	1085925	vienadozė talpyklė	0,3 ml N30		Receptinis	EU/1/17/1219/001	Netiekiama	-	-	No	-	-
99818	85926	1085926	vienadozė talpyklė	0,3 ml N60		Receptinis	EU/1/17/1219/002	Netiekiama	-	-	No	-	-
99819	85927	1085927	vienadozė talpyklė	0,3 ml N90		Receptinis	EU/1/17/1219/003	Netiekiama	-	-	No	-	-
99820	85928	1085928	vienadozė talpyklė	0,3 ml N120		Receptinis	EU/1/17/1219/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-04-06	Registruotas