Myclausen

Medicinal product

(Invented) name

Myclausen

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

Passauer Pharma GmbH, Vokietija

Date of authorisation

2010-10-07

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	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
43453	57225	1057225	lizdinė plokštelė	N50		Receptinis	EU/1/10/647/001	Netiekiama	-	-	No	-	-
43454	57226	1057226	lizdinė plokštelė	N150		Receptinis	EU/1/10/647/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-10-07	Registruotas