Montelukast Orion

Medicinal product

(Invented) name

Montelukast Orion

Active substance (s)

Montelukastas

Strength

5 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/0888/002

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Montelukastas	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
35045	37385	1037385	lizdinė plokštelė	N28		Receptinis	LT/1/10/2275/004	Netiekiama	-	-	No	-	-	Download
44439	58232	1058232	lizdinė plokštelė	N56		Receptinis	LT/1/10/2275/005	Netiekiama	-	-	No	-	-
44440	58233	1058233	lizdinė plokštelė	N98		Receptinis	LT/1/10/2275/006	Netiekiama	-	-	No	-	-

Stadijos

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