DEXAMETAZONA Rompharm

Medicinal product

(Invented) name

DEXAMETAZONA Rompharm

Active substance (s)

Deksametazono natrio fosfatas

Strength

4 mg/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)

H02AB02, Dexamethasone

Marketing authorisation holder

UAB Tojaris projektai, Lietuva

Date of authorisation

2023-02-08

Date of renewal

Documents

1826_DEXAMETAZONA Rompharm 4mg-ml_inj_inf_tirp_PZPL_2023-02-08.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Ampulėje (1 ml) yra	1 ml
Deksametazono natrio 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
110360	96471	1096471	ampulė	2 ml N10		Receptinis	LT/L/23/1826/001	Netiekiama	-	-	No	-	-	Download
110361	96472	1096472	ampulė	2 ml N20		Receptinis	LT/L/23/1826/002	Netiekiama	-	-	No	-	-
110362	96473	1096473	ampulė	2 ml N30		Receptinis	LT/L/23/1826/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-02-08	Registruotas