Juluca

Medicinal product

(Invented) name

Juluca

Active substance (s)

Dolutegraviras/Rilpivirinas

Strength

50 mg/25 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)

J05AR21, Dolutegravir and rilpivirine

Marketing authorisation holder

ViiV Healthcare BV, Nyderlandai

Date of authorisation

2018-05-16

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Dolutegraviras	50 mg
Rilpivirinas	25 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
99500	85607	1085607	buteliukas	N30		Receptinis	EU/1/18/1282/001	Netiekiama	-	-	No	-	-
99501	85608	1085608	buteliukas	N90 (3x30)		Receptinis	EU/1/18/1282/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-05-16	Registruotas