Dexamethasone Kalceks

Medicinal product

(Invented) name

Active substance (s)

Deksametazono natrio fosfatas

Strength

4 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis, infiltracija, leisti į sąnarį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

H02AB02, Dexamethasone

Marketing authorisation holder

AS Kalceks, Latvija

Date of authorisation

2021-12-02

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

EE/H0337/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Deksametazono natrio fosfatas	4 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
107688	93793	1093793	ampulė	1 ml N3	Receptinis	LT/1/21/4858/001	Netiekiama	-	-	No	-	-
107689	93794	1093794	ampulė	1 ml N10	Receptinis	LT/1/21/4858/002	Netiekiama	-	-	No	-	-
107690	93795	1093795	ampulė	1 ml N25	Receptinis	LT/1/21/4858/003	Netiekiama	2025-01-31	2025-08-31	No	-	-
107691	93796	1093796	ampulė	1 ml N50	Receptinis	LT/1/21/4858/004	Netiekiama	-	-	No	-	-
107692	93797	1093797	ampulė	1 ml N100	Receptinis	LT/1/21/4858/005	Netiekiama	-	-	No	-	-
107693	93798	1093798	ampulė	2 ml N5	Receptinis	LT/1/21/4858/006	Netiekiama	-	-	No	-	-
107694	93799	1093799	ampulė	2 ml N10	Receptinis	LT/1/21/4858/007	Netiekiama	-	-	No	-	-
107695	93800	1093800	ampulė	2 ml N25	Receptinis	LT/1/21/4858/008	Netiekiama	-	-	No	-	-
107696	93801	1093801	ampulė	2 ml N50	Receptinis	LT/1/21/4858/009	Netiekiama	-	-	No	-	-
107697	93802	1093802	ampulė	2 ml N100	Receptinis	LT/1/21/4858/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-02	Registruotas