Amifampridine SERB

Medicinal product

(Invented) name

Amifampridine SERB

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

2022-05-19

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

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
108730	94836	1094836	dalomoji lizdinė plokštelė	N90×1		Receptinis	EU/1/22/1646/001	Netiekiama	-	-	No	-	-
108731	94837	1094837	dalomoji lizdinė plokštelė	N100×1		Receptinis	EU/1/22/1646/002	Netiekiama	-	-	No	-	-
108732	94838	1094838	dalomoji lizdinė plokštelė	N120×1		Receptinis	EU/1/22/1646/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-05-19	Registruotas