Rukobia

Medicinal product

(Invented) name

Rukobia

Active substance (s)

Fostemsaviras

Strength

600 mg

Pharmaceutical form

pailginto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AX29, fostemsavir

Marketing authorisation holder

ViiV Healthcare BV, Nyderlandai

Date of authorisation

2021-02-04

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

Prolonged-release tablet	1 vnt.
Fostemsaviras	600 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
105716	91816	1091816	buteliukas	N60		Receptinis	EU/1/20/1518/001	Netiekiama	-	-	No	-	-
108494	94598	1094598	buteliukas	N180 (3×60)		Receptinis	EU/1/20/1518/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-04	Registruotas