DIFICLIR

Medicinal product

(Invented) name

DIFICLIR

Active substance (s)

Fidaksomicinas

Strength

200 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)

A07AA12, Fidaxomicin

Marketing authorisation holder

Tillotts Pharma GmbH, Vokietija

Date of authorisation

2011-12-05

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

Film-coated tablet	1 vnt.
Fidaksomicinas	200 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
50318	64202	1064202	dalomoji lizdinė plokštelė	N100x1		Receptinis	EU/1/11/733/003	Netiekiama	-	-	No	-	-
50319	64203	1064203	dalomoji lizdinė plokštelė	N20x1		Receptinis	EU/1/11/733/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-12-05	Registruotas