Emadine

Medicinal product

(Invented) name

Emadine

Active substance (s)

Emedastinas

Strength

0,5 mg/ml

Pharmaceutical form

akių lašai (tirpalas vienadozėje talpyklėje)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01GX06, Emedastine

Marketing authorisation holder

Immedica Pharma AB, Švedija

Date of authorisation

2002-05-30

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
Emedastinas	0,5 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
25357	27965	1027965	vienadozė talpyklė	0,35 ml, N30		Receptinis	EU/1/98/095/003	Netiekiama	-	-	No	-	-
25358	27966	1027966	vienadozė talpyklė	0,35 ml, N60		Receptinis	EU/1/98/095/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-05-30	Registruotas