Magnesium sulfate heptahydrate Kalceks

Medicinal product

(Invented) name

Magnesium sulfate heptahydrate Kalceks

Active substance (s)

Magnio sulfatas heptahidratas

Strength

250 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B05XA05, Magnesium sulfate

Marketing authorisation holder

AS Kalceks, Latvija

Date of authorisation

2016-03-10

Date of renewal

2020-11-20

Documents

3886 Pakuotės lapelis 2024 10 01.docx

Magnesium_sulfate_heptah_BB_AR.pdf

3886 Magnesium sulf heptah Kalceks PL 2024 10 01, VRA_17041.docx

Stage

Perregistruotas

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
Magnio sulfatas heptahidratas	250 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
61770	76126	1076126	ampulė	10 ml N10		Receptinis	LT/1/16/3886/001	Tiekiama	2025-08-31	-	No	-	-	Download

Stadijos

Data	Stadija
2020-11-20	Perregistruotas
2016-03-10	Registruotas