Olopatadine UNIMED PHARMA

Medicinal product

(Invented) name

Olopatadine UNIMED PHARMA

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

UNIMED PHARMA spol. s r.o., Slovakija

Date of authorisation

2020-02-27

Date of renewal

2025-01-28

Documents

4524_pakuotes lapelis_2025-01-28.docx

4524_Olop_UNIMED Ph_perr2025-01-28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SK/H/0202/001/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
103374	89476	1089476	buteliukas	5 ml N1		Receptinis	LT/1/20/4524/001	Tiekiama	-	-	No	-	-
103375	89477	1089477	buteliukas	10 ml N1		Receptinis	LT/1/20/4524/002	Netiekiama	-	-	No	-	-
110758	96869	1096869	buteliukas	5 ml N3		Receptinis	LT/1/20/4524/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-28	Perregistruotas
2020-02-27	Registruotas