Dovato

Medicinal product

(Invented) name

Dovato

Active substance (s)

Dolutegraviras/Lamivudinas

Strength

50 mg/300 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)

J05AR25, lamivudine and dolutegravir

Marketing authorisation holder

ViiV Healthcare BV, Nyderlandai

Date of authorisation

2019-07-01

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
Lamivudinas	300 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
102155	88256	1088256	buteliukas	N30		Receptinis	EU/1/19/1370/001	Tiekiama	-	-	No	-	-
102156	88257	1088257	buteliukas	N90 (3x30)		Receptinis	EU/1/19/1370/002	Netiekiama	-	-	No	-	-
111596	97709	1097709	lizdinė plokštelė	N30		Receptinis	EU/1/19/1370/003	Netiekiama	-	-	No	-	-
111597	97710	1097710	lizdinė plokštelė	N90 (3×30)		Receptinis	EU/1/19/1370/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-07-01	Registruotas