Omidria

Medicinal product

(Invented) name

Omidria

Active substance (s)

Fenilefrinas/Ketorolakas

Strength

10 mg/3 mg/ml

Pharmaceutical form

koncentratas akių plovimo tirpalui

Route (s) of administration

vartoti į akis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01FB51, Phenylephrine and ketorolac

Marketing authorisation holder

Rayner Surgical (Ireland) Limited, Airija

Date of authorisation

2015-07-28

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

Concentrate for solution for intraocular irrigation	1 ml
Fenilefrinas	10 mg
Ketorolakas	3 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
63409	77848	1077848	flakonas	N10		Receptinis	EU/1/15/1018/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-07-28	Registruotas