DIRONORM

Medicinal product

(Invented) name

DIRONORM

Active substance (s)

Lizinoprilis/Amlodipinas

Strength

20 mg/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)

C09BB03, Lisinopril and amlodipine

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2012-03-15

Date of renewal

2014-11-25

Documents

1442 DIRONORM PCS PL 2022 08 14.docx

1442 Pakuotės lapelis 2022 08 14.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

HU/H/0133/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Lizinoprilis	20 mg
Amlodipinas	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
43479	57251	1057251	lizdinė plokštelė	N30		Receptinis	LT/1/09/1442/004	Tiekiama	-	-	No	-	-	Download
51504	65400	1065400	lizdinė plokštelė	N90		Receptinis	LT/1/09/1442/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-11-25	Perregistruotas
2012-03-15	Registruotas