Montelukast Orion

Medicinal product

(Invented) name

Montelukast Orion

Active substance (s)

Montelukastas

Strength

10 mg

Pharmaceutical form

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/0887/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Montelukastas	10 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
35046	37386	1037386	lizdinė plokštelė	N28		Receptinis	LT/1/10/2275/007	Netiekiama	-	-	No	-	-	Download
44441	58234	1058234	lizdinė plokštelė	N56		Receptinis	LT/1/10/2275/008	Netiekiama	-	-	No	-	-
44442	58235	1058235	lizdinė plokštelė	N98		Receptinis	LT/1/10/2275/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-06-05	Išregistruotas
2016-10-11	Perregistruotas
2010-12-28	Registruotas