DIFICLIR

Medicinal product

(Invented) name

DIFICLIR

Active substance (s)

Fidaksomicinas

Strength

40 mg/ml

Pharmaceutical form

granulės geriamajai suspensijai

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

Granules for oral suspension	1 ml
Fidaksomicinas	40 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
103428	89530	1089530	buteliukas	7,7 g (110 ml) N1		Receptinis	EU/1/11/733/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-12-05	Registruotas