BELKYRA

Medicinal product

(Invented) name

BELKYRA

Active substance (s)

Deoksicholio rūgštis

Strength

10 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D11AX24, Deoxycholic acid

Marketing authorisation holder

AbbVie SIA, Latvija

Date of authorisation

2016-09-09

Date of renewal

2021-06-29

Documents

3960 Pakuotės lapelis 2023 04 20.docx

3960 BELKYRA PCS PL 2023 04 20.docx

Belkyra mokomoji medziaga sveikatos prieziuros specialistams.pdf

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/1547/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Deoksicholio rūgštis	10 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
63322	77740	1077740	flakonas	2 ml N4		Receptinis	LT/1/16/3960/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2023-12-27	Išregistruotas
2021-06-29	Perregistruotas
2016-09-09	Registruotas