OXERVATE

Medicinal product

(Invented) name

OXERVATE

Active substance (s)

Cenegerminas

Strength

20 µg/ml

Pharmaceutical form

akių lašai (tirpalas)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01XA24, Cenegermin

Marketing authorisation holder

Dompe Farmaceutici S.p.A, Italija

Date of authorisation

2017-07-06

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, solution	1 ml
Cenegerminas	20 µg

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
68819	83402	1083402	flakonas	N7		Receptinis	EU/1/17/1197/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-07-06	Registruotas