Opatanol

Medicinal product

(Invented) name

Opatanol

Active substance (s)

Olopatadinas

Strength

1 mg/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)

S01GX09, Olopatadine

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2002-05-17

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
Olopatadinas	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
27773	30315	1030315	buteliukas	5 ml N1		Receptinis	EU/1/02/217/001	Tiekiama	-	-	No	-	-
50263	64140	1064140	buteliukas	5 ml N3		Receptinis	EU/1/02/217/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-05-17	Registruotas