The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Magnaspartate 243 mg powder for oral solution



Kora Corporation Ltd t/a Kora HealthcarePA1748/002/001

Main Information

Trade NameMagnaspartate 243 mg powder for oral solution
Active SubstancesMagnesium aspartate dihydrate
Dosage FormPowder for oral solution
Licence HolderKora Corporation Ltd t/a Kora Healthcare
Licence NumberPA1748/002/001

Group Information

ATC CodeA12CC Magnesium
A12CC05 magnesium aspartate

Status

Authorised/WithdrawnAuthorised
Licence Issued15/05/2015
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicencePost approval commitment The applicant has clarified that to date other fillers have not been investigated, but the applicant intends to replace the sucrose in the formulation with other non-cariogenic filler(s). The applicant has made a commitment to replace the sucrose in the formulation with other non-cariogenic filler(s). The applicant commits to submit a variation to the competent authorities for this change within 12 months of close of procedure.
Marketing StatusMarketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportPDF Version
« Back