Varuby

Medicinal product

(Invented) name

Varuby

Active substance (s)

Rolapitantas

Strength

90 mg

Pharmaceutical form

dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A04AD14, Rolapitant

Marketing authorisation holder

TESARO Bio Netherlands B.V., Nyderlandai

Date of authorisation

2017-04-20

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Coated tablet	1 vnt.
Rolapitantas	90 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
68112	82677	1082677	lizdinė plokštelė	N2		Receptinis	EU/1/17/1180/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-01-23	Išregistruotas
2017-04-20	Registruotas