Myclausen

Medicinal product

(Invented) name

Myclausen

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

Passauer Pharma GmbH, Vokietija

Date of authorisation

2011-09-16

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

Capsule, 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
49425	63294	1063294	lizdinė plokštelė	N100		Receptinis	EU/1/10/647/003	Netiekiama	-	-	No	-	-
57472	71588	1071588	lizdinė plokštelė	N300		Receptinis	EU/1/10/647/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-09-16	Registruotas