HEPCLUDEX

Medicinal product

(Invented) name

HEPCLUDEX

Active substance (s)

Bulevirtidas

Strength

2 mg

Pharmaceutical form

milteliai injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J05AX28, bulevirtide

Marketing authorisation holder

Gilead Sciences Ireland UC, Airija

Date of authorisation

2020-07-31

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

Powder for solution for injection	1 vnt.
Bulevirtidas	2 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
104862	90963	1090963	flakonas	N30		Receptinis	EU/1/20/1446/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-07-31	Registruotas