Perindobax

Medicinal product

(Invented) name

Perindobax

Active substance (s)

tert-butilamino perindoprilis

Strength

8 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C09AA04, Perindopril

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B. V., Nyderlandai

Date of authorisation

2008-08-12

Date of renewal

2012-12-05

Documents

1125 Perindobax PCS PL 2025 01 03.docx

1125 Pakuotės lapelis 2025 01 03.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/0977/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
tert-butilamino perindoprilis	8 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
21693	5159	1005159	lizdinė plokštelė	N30		Receptinis	LT/1/08/1125/006	Tiekiama	-	-	No	-	-
31521	33943	1033943	lizdinė plokštelė	N60		Receptinis	LT/1/08/1125/007	Netiekiama	-	-	No	-	-
31522	33944	1033944	lizdinė plokštelė	N90		Receptinis	LT/1/08/1125/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-02	Išregistruotas
2012-12-05	Perregistruotas
2008-08-12	Registruotas