Apretude

Medicinal product

(Invented) name

Apretude

Active substance (s)

Kabotegraviras

Strength

600 mg

Pharmaceutical form

pailginto atpalaidavimo injekcinė suspensija

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AJ04, cabotegravir

Marketing authorisation holder

ViiV Healthcare BV, Nyderlandai

Date of authorisation

2023-09-15

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

Prolonged-release suspension for injection	3 ml
Kabotegraviras	600 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
111676	97789	1097789	flakonas	3 ml N1		Receptinis	EU/1/23/1760/002	Netiekiama	-	-	No	-	-
111677	97790	1097790	flakonas	3 ml N25		Receptinis	EU/1/23/1760/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-15	Registruotas