Alzepil

Medicinal product

(Invented) name

Alzepil

Active substance (s)

Donepezilo hidrochloridas

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)

N06DA02, Donepezil

Marketing authorisation holder

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2009-05-05

Date of renewal

2014-08-01

Documents

1550 Alzepil PCS PL 2022 01 02.docx

1550 Pakuotės lapelis 2022 01 02.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0135/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Donepezilo hidrochloridas	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
27192	29749	1029749	lizdinė plokštelė	N28		Receptinis	LT/1/09/1550/003	Netiekiama	-	-	No	-	-
35341	37675	1037675	lizdinė plokštelė	N56		Receptinis	LT/1/09/1550/004	Netiekiama	-	-	No	-	-

Stadijos

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