Atorvastatin-EGIS

Medicinal product

(Invented) name

Atorvastatin-EGIS

Active substance (s)

Atorvastatinas

Strength

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)

C10AA05, Atorvastatin

Marketing authorisation holder

EGIS Pharmaceuticals PLC, Vengrija

Date of authorisation

2010-06-18

Date of renewal

2015-04-22

Documents

2067 Pakuotės lapelis 2021 05 29.docx

2067 Atorvastatin_EGIS tab PCS PL 2021 05 29.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0225/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Atorvastatinas	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
33034	35414	1035414	buteliukas	N30		Receptinis	LT/1/10/2067/001	Netiekiama	-	-	No	-	-
41566	55327	1055327	lizdinė plokštelė	N30		Receptinis	LT/1/10/2067/002	Netiekiama	-	-	No	-	-
41567	55328	1055328	lizdinė plokštelė	N90		Receptinis	LT/1/10/2067/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-01-31	Išregistruotas
2015-04-22	Perregistruotas
2010-06-18	Registruotas