CellCept

Medicinal product

(Invented) name

CellCept

Active substance (s)

Mikofenolato mofetilis

Strength

250 mg

Pharmaceutical form

kietosios kapsulės

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

Roche Registration GmbH, Vokietija

Date of authorisation

1996-02-14

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsules, hard	1 vnt.
Mikofenolato mofetilis	250 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
2251	7882	1007882	lizdinė plokštelė	N100		Receptinis	EU/1/96/005/001	Netiekiama	-	-	No	-	-
2624	8199	1008199	lizdinė plokštelė	N300		Receptinis	EU/1/96/005/003	Netiekiama	-	-	No	-	-
103774	89876	1089876	lizdinė plokštelė	N300 (3x100)		Receptinis	EU/1/96/005/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1996-02-14	Registruotas