Ezetimibe/Atorvastatin Olpha [Ezetimibe/Atorvastatin Olainfarm]

Medicinal product

(Invented) name

Active substance (s)

Ezetimibas/Atorvastatinas

Strength

10 mg/80 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)

C10BA05, Atorvastatin and ezetimibe

Marketing authorisation holder

Olpha AS, Latvija

Date of authorisation

2024-01-30

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5685/004/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Ezetimibas	10 mg
Atorvastatinas	80 mg

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
112673	98793	1098793	lizdinė plokštelė	N10	Receptinis	LT/1/24/5336/001	Netiekiama	-	-	No	-	-
112674	98794	1098794	lizdinė plokštelė	N30	Receptinis	LT/1/24/5336/002	Netiekiama	-	-	No	-	-
112675	98795	1098795	lizdinė plokštelė	N90	Receptinis	LT/1/24/5336/003	Netiekiama	-	-	No	-	-
112676	98796	1098796	lizdinė plokštelė	N100	Receptinis	LT/1/24/5336/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-01-30	Registruotas