Mycophenolate Mofetil Accord

Medicinal product

(Invented) name

Mycophenolate Mofetil Accord

Active substance (s)

Mikofenolato mofetilis

Strength

500 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

L04AA06, Mycophenolic acid

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2009-07-21

Date of renewal

2018-05-29

Documents

Mycofenolate Mofetil Accord mokomoji medžiaga pacientams.pdf

Mycofenolate Mofetil Accord mokomoji medžiaga sveikatos priežiūros specialistams.pdf

1641 Pakuotės lapelis 2025 08 05.docx

1641 Mycophenolate Mofetil Accord II PL 2025 08 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4839/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Mikofenolato mofetilis	500 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
21488	5460	1005460	lizdinė plokštelė	N50		Receptinis	LT/1/09/1641/001	Netiekiama	2025-05-29	2025-12-31	Yes	2025-07-07	2025-12-31
36228	38560	1038560	lizdinė plokštelė	N150		Receptinis	LT/1/09/1641/002	Netiekiama	-	-	No	-	-
67263	81809	1081809	lizdinė plokštelė	N250		Receptinis	LT/1/09/1641/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-05-29	Perregistruotas
2009-07-21	Registruotas