Dexamethasone phosphate Sopharma [Dexamethasone phosphate Sveikuva]

Medicinal product

(Invented) name

Active substance (s)

Deksametazono fosfatas

Strength

4 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis, leisti po jungine, infiltracija, leisti į sąnarį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

H02AB02, Dexamethasone

Marketing authorisation holder

SOPHARMA AD, Bulgarija

Date of authorisation

2023-12-14

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Deksametazono fosfatas	4 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
112284	98399	1098399	ampulė	1 ml N10		Receptinis	LT/1/23/5296/001	Tiekiama	2025-06-01	-	No	-	-
112285	98400	1098400	ampulė	1 ml N100		Receptinis	LT/1/23/5296/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-14	Registruotas