Digoxin Sopharma [Digoxin Sveikuva]

Medicinal product

(Invented) name

Digoxin Sopharma [Digoxin Sveikuva]

Active substance (s)

Digoksinas

Strength

250 µg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01AA05, Digoxin

Marketing authorisation holder

SOPHARMA AD, Bulgarija

Date of authorisation

2024-04-05

Date of renewal

Documents

5394 Pakuotės lapelis 2024 07 02.docx

Digoxin Sveikuva_NP_registracija_viešas_AR.pdf

5394 Digoxin Sopharma RPP 2024 07 02.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Digoksinas	250 µg

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
113281	99400	1099400	ampulė	2 ml N10		Receptinis	LT/1/24/5394/001	Netiekiama	-	2025-06-29	No	-	-
113282	99401	1099401	ampulė	2 ml N50		Receptinis	LT/1/24/5394/002	Netiekiama	-	-	No	-	-
113283	99402	1099402	ampulė	2 ml N100		Receptinis	LT/1/24/5394/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-05	Registruotas