Alzepil

Medicinal product

(Invented) name

Alzepil

Active substance (s)

Donepezilo hidrochloridas

Strength

5 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)

N06DA02, Donepezil

Marketing authorisation holder

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2009-05-05

Date of renewal

2014-08-01

Documents

1550 Pakuotės lapelis 2022 01 02.docx

1550 Alzepil PCS PL 2022 01 02.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0135/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Donepezilo hidrochloridas	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
27191	29748	1029748	lizdinė plokštelė	N28		Receptinis	LT/1/09/1550/001	Netiekiama	-	-	No	-	-
35340	37674	1037674	lizdinė plokštelė	N56		Receptinis	LT/1/09/1550/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-02-28	Išregistruotas
2014-08-01	Perregistruotas
2009-05-05	Registruotas