Apremilast Accord

Medicinal product

(Invented) name

Apremilast Accord

Active substance (s)

Apremilastas

Strength

30 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)

L04AA32, Apremilast

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2024-04-19

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

Tabletėje yra:	1 vnt.
Apremilastas	30 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
113548	99667	1099667	lizdinė plokštelė	N56		Receptinis	EU/1/24/1796/002	Netiekiama	-	-	No	-	-
113549	99668	1099668	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/24/1796/003	Netiekiama	-	-	No	-	-
113550	99669	1099669	lizdinė plokštelė	N168 (3×56)		Receptinis	EU/1/24/1796/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-19	Registruotas