Fampridine Accord

Medicinal product

(Invented) name

Fampridine Accord

Active substance (s)

Fampridinas

Strength

10 mg

Pharmaceutical form

pailginto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07XX07, Fampridine

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2020-09-24

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

Tabletėje yra:	1 vnt.
Fampridinas	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
105138	91240	1091240	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/20/1477/001	Netiekiama	-	-	No	-	-
105139	91241	1091241	dalomoji lizdinė plokštelė	N56x1		Receptinis	EU/1/20/1477/002	Netiekiama	-	-	No	-	-
116077	102178	1102178	dalomoji lizdinė plokštelė	N49×1		Receptinis	EU/1/20/1477/003	Netiekiama	-	-	No	-	-
116078	102179	1102179	dalomoji lizdinė plokštelė	N196 (4×N49×1)		Receptinis	EU/1/20/1477/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-09-24	Registruotas