Perindopril arginine/Indapamide/Amlodipine Teva

Medicinal product

(Invented) name

Perindopril arginine/Indapamide/Amlodipine Teva

Active substance (s)

Perindoprilio argininas/Indapamidas/Amlodipinas

Strength

5 mg/1,25 mg/10 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C09BX01, Perindopril, amlodipine and indapamide

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2024-09-25

Date of renewal

Documents

5583-86_pakuotes lapelis_2024-09-25.docx

5583-5586_Perindop_Indap_Amlod_Teva.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

CZ/H/1134/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Perindoprilio argininas	5 mg
Indapamidas	1,25 mg
Amlodipinas	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
115158	101267	1101267	lizdinė plokštelė	N10		Receptinis	LT/1/24/5584/001	Netiekiama	-	-	No	-	-
115159	101268	1101268	lizdinė plokštelė	N30		Receptinis	LT/1/24/5584/002	Tiekiama	2025-05-07	-	No	-	-
115160	101269	1101269	lizdinė plokštelė	N90		Receptinis	LT/1/24/5584/003	Netiekiama	-	-	No	-	-
115161	101270	1101270	lizdinė plokštelė	N100		Receptinis	LT/1/24/5584/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-25	Registruotas