Montelukast Orion

Medicinal product

(Invented) name

Montelukast Orion

Active substance (s)

Montelukastas

Strength

4 mg

Pharmaceutical form

kramtomosios tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03DC03, Montelukast

Marketing authorisation holder

Orion Corporation, Suomija

Date of authorisation

2010-12-28

Date of renewal

2016-10-11

Documents

2275_1_9 Montelukast Orion 4mg_5mg_10mg RPP 171215.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/0888/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Montelukastas	4 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
35044	37384	1037384	lizdinė plokštelė	N28		Receptinis	LT/1/10/2275/001	Netiekiama	-	-	No	-	-	Download
44437	58230	1058230	lizdinė plokštelė	N56		Receptinis	LT/1/10/2275/002	Netiekiama	-	-	No	-	-
44438	58231	1058231	lizdinė plokštelė	N98		Receptinis	LT/1/10/2275/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-03-05	Išregistruotas
2016-10-11	Perregistruotas
2010-12-28	Registruotas