Alerpalux

Medicinal product

(Invented) name

Alerpalux

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

PharmaSwiss Česká republika s.r.o., Čekija

Date of authorisation

2013-10-31

Date of renewal

2019-06-10

Documents

3411_1-2 Alerpalux_perr2019-06-10.docx

3411_01-02 pakuotes lapelis_2019-06-10.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PL/H/0248/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	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
52938	66877	1066877	buteliukas	5 ml N1		Receptinis	LT/1/13/3411/001	Netiekiama	-	-	No	-	-	Download
57721	71841	1071841	buteliukas	5 ml N3		Receptinis	LT/1/13/3411/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-10-30	Išregistruotas
2019-06-10	Perregistruotas
2013-10-31	Registruotas