Dexamethasone phosphate IBE

Medicinal product

(Invented) name

Dexamethasone phosphate IBE

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 į sąnarį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H02AB02, Dexamethasone

Marketing authorisation holder

UAB Eletis Pharma, Lietuva

Date of authorisation

2024-04-05

Date of renewal

Documents

Dexamethasone phosphate IBE 4 mg_ml_viešas_AR.pdf

5393 Pakuotės lapelis 2024 04 17.docx

5393 Dexamethasone phosphate IBE RPP 2024 04 17.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Ampulėje (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
113280	99399	1099399	ampulė	N25		Receptinis	LT/1/24/5393/001	Tiekiama	2025-01-23	-	No	-	-

Stadijos

Data	Stadija
2024-04-05	Registruotas