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Gliclazide MR 30 mg prolonged-release tablets



Brillpharma (Ireland) LimitedPA22749/006/001

Main Information

Trade NameGliclazide MR 30 mg prolonged-release tablets
Active SubstancesGliclazide
Dosage FormProlonged-release tablet
Licence HolderBrillpharma (Ireland) Limited
Licence NumberPA22749/006/001

Group Information

ATC CodeA10BB Sulfonamides, urea derivatives
A10BB09 gliclazide

Status

License statusAuthorised
Licence Issued12/09/2014
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceThe name Gliclazide MR 30mg prolonged-release tablets is a ‘registration’ name. It has been agreed subject to the following conditions: a) The MAH commits not to market the product using the ‘registration’ name. b) The MAH commits to change the ‘registration’ name to an invented name by variation prior to marketing in Ireland
Marketing StatusNot marketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available

Generics Information

Interchangeable ListGliclazide 30mg Prolonged Release Tablets/Modified Release Tablets
Interchangeable List CodeIC0086-033-050
Interchangeable List DocumentPDF of Interchangeable List
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