Delstrigo

Medicinal product

(Invented) name

Delstrigo

Active substance (s)

Doravirinas/Lamivudinas/Tenofoviro dizoproksilis

Strength

100 mg/300 mg/245 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)

J05AR24, Lamivudine, tenofovir disoproxil and doravirine

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2018-11-22

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.
Doravirinas	100 mg
Lamivudinas	300 mg
Tenofoviro dizoproksilis	245 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
100517	86626	1086626	buteliukas	N30		Receptinis	EU/1/18/1333/001	Tiekiama	-	-	No	-	-
100518	86627	1086627	buteliukas	N90 (3x30)		Receptinis	EU/1/18/1333/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-11-22	Registruotas