Otezla

Medicinal product

(Invented) name

Otezla

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

Amgen Europe B.V., Nyderlandai

Date of authorisation

2015-01-15

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

Film-coated tabled	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
61154	75468	1075468	lizdinė plokštelė	N56		Receptinis	EU/1/14/981/002	Tiekiama	-	-	No	-	-
61155	75469	1075469	lizdinė plokštelė	N168		Receptinis	EU/1/14/981/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-01-15	Registruotas