Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Accord

Medicinal product

(Invented) name

Active substance (s)

Olmesartanas medoksomilis/Amlodipinas/Hidrochlorotiazidas

Strength

40 mg/5 mg/12,5 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

C09DX03, Olmesartan medoxomil, amlodipine and hydrochlorothiazide

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2020-04-29

Date of renewal

2024-10-22

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

ES/H/0623/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
103963	90065	1090065	lizdinė plokštelė	N14	Receptinis	LT/1/20/4554/001	Netiekiama	-	-	No	-	-
103964	90066	1090066	lizdinė plokštelė	N28	Receptinis	LT/1/20/4554/002	Netiekiama	-	-	No	-	-
103965	90067	1090067	lizdinė plokštelė	N56	Receptinis	LT/1/20/4554/003	Netiekiama	-	-	No	-	-
103966	90068	1090068	lizdinė plokštelė	N98	Receptinis	LT/1/20/4554/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-10-22	Perregistruotas
2020-04-29	Registruotas