Fosinopril HCT Actavis

Medicinal product

(Invented) name

Fosinopril HCT Actavis

Active substance (s)

Fosinoprilio natrio druska/Hidrochlorotiazidas

Strength

20 mg/12,5 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C09BA09, Fosinopril and diuretics

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2007-04-05

Date of renewal

2014-02-26

Documents

0703 Pakuotės lapelis 2023 08 29.docx

0703 Fosinopril HCT Actavis PCS PL 2023 08 29.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H/0257/001

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Fosinoprilio natrio druska	20 mg
Hidrochlorotiazidas	12,5 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
20136	23232	1023232	lizdinė plokštelė	N20		Receptinis	LT/1/07/0703/001	Netiekiama	-	-	No	-	-
22242	4752	1004752	lizdinė plokštelė	N30		Receptinis	LT/1/07/0703/002	Tiekiama	-	-	No	-	-	Download
22243	25042	1025042	lizdinė plokštelė	N50		Receptinis	LT/1/07/0703/003	Netiekiama	-	-	No	-	-
22244	25043	1025043	lizdinė plokštelė	N100		Receptinis	LT/1/07/0703/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-02-26	Perregistruotas
2007-04-05	Registruotas