FIRDAPSE

Medicinal product

(Invented) name

FIRDAPSE

Active substance (s)

Amifampridinas

Strength

10 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07XX05, Amifampridine

Marketing authorisation holder

SERB SA, Belgija

Date of authorisation

2009-12-23

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

Tablet	1 vnt.
Amifampridinas	10 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
39227	52910	1052910	dalomoji lizdinė plokštelė	N100x1		Receptinis	EU/1/09/601/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-12-23	Registruotas