Daxas

Medicinal product

(Invented) name

Daxas

Active substance (s)

Roflumilastas

Strength

250 µg

Pharmaceutical form

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

2010-07-05

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

Tablet	1 vnt.
Roflumilastas	250 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
99283	85389	1085389	lizdinė plokštelė	N28		Receptinis	EU/1/10/636/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-07-05	Registruotas