Otezla

Medicinal product

(Invented) name

Otezla

Active substance (s)

Apremilastas+Apremilastas+Apremilastas

Strength

10 mg + 20 mg + 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 tablet (10 mg)	1 vnt.
Apremilastas	10 mg
Film-coated tablet (20 mg)	1 vnt.
Apremilastas	20 mg
Film-coated tablet (30 mg)	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
61153	75467	1075467	lizdinė plokštelė	N27 (4x10 mg, 4x20 mg, 19x30 mg)		Receptinis	EU/1/14/981/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-01-15	Registruotas