Tivicay

Medicinal product

(Invented) name

Tivicay

Active substance (s)

Dolutegraviras

Strength

5 mg

Pharmaceutical form

disperguojamosios 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

Dispersible tablets	1 vnt.
Dolutegraviras	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
105654	91754	1091754	buteliukas	N60 (matavimo taurelė ir geriamasis švirkštas)		Receptinis	EU/1/13/892/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-01-16	Registruotas