Revolade

Medicinal product

(Invented) name

Revolade

Active substance (s)

Eltrombopagas

Strength

12,5 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)

B02BX05, Eltrombopag

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2010-03-11

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	1 vnt.
Eltrombopagas	12,5 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
65513	80020	1080020	lizdinė plokštelė	N14		Receptinis	EU/1/10/612/010	Netiekiama	-	-	No	-	-
65514	80021	1080021	lizdinė plokštelė	N28		Receptinis	EU/1/10/612/011	Netiekiama	-	-	No	-	-
65515	80022	1080022	lizdinė plokštelė	N84 (3x28) (sudėtinė)		Receptinis	EU/1/10/612/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-03-11	Registruotas