Otezla

Medicinal product

(Invented) name

Otezla

Active substance (s)

Apremilastas+Apremilastas

Strength

10 mg + 20 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

Tabletėje (rausva, 10 mg) yra:	1 vnt.
Apremilastas	10 mg
Tabletėje (ruda, 20 mg) yra:	1 vnt.
Apremilastas	20 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
115568	101675	1101675	lizdinė plokštelė	N27 (N4×10 mg + N23×20 mg)	pakuotė gydymui pradėti	Receptinis	EU/1/14/981/004	Nepradėtas tiekti	-	-	No	-	-

Stadijos

Data	Stadija
2015-01-15	Registruotas