Libertek

Medicinal product

(Invented) name

Libertek

Active substance (s)

Roflumilastas

Strength

500 µg

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)

R03DX07, Roflumilast

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2011-02-28

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Roflumilastas	500 µg

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
45457	59257	1059257	lizdinė plokštelė	N10		Receptinis	EU/1/11/666/001	Netiekiama	-	-	No	-	-
45458	59258	1059258	lizdinė plokštelė	N30		Receptinis	EU/1/11/666/002	Netiekiama	-	-	No	-	-
45459	59259	1059259	lizdinė plokštelė	N90		Receptinis	EU/1/11/666/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-01-15	Išregistruotas
2011-02-28	Registruotas