Tivicay

Medicinal product

(Invented) name

Tivicay

Active substance (s)

Dolutegraviras

Strength

50 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)

J05AJ03, Dolutegravir

Marketing authorisation holder

ViiV Healthcare BV, Nyderlandai

Date of authorisation

2014-01-16

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.
Dolutegraviras	50 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
58465	72629	1072629	buteliukas	N30		Receptinis	EU/1/13/892/001	Tiekiama	-	-	No	-	-
58466	72630	1072630	buteliukas	N90		Receptinis	EU/1/13/892/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-01-16	Registruotas