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


Montelukast Mylan 4 mg Chewable Tablets



McDermott Laboratories Ltd., T/A Gerard LaboratoriesPA0577/131/001

Main Information

Trade NameMontelukast Mylan 4 mg Chewable Tablets
Active SubstancesMontelukast
Dosage FormChewable tablet
Licence HolderMcDermott Laboratories Ltd., T/A Gerard Laboratories
Licence NumberPA0577/131/001

Group Information

ATC CodeR03DC Leukotriene receptor antagonists
R03DC03 montelukast

Status

License statusAuthorised
Licence Issued20/05/2011
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusNot marketed

Documents

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

Generics Information

Interchangeable List CodeIC0023-008-007
Interchangeable List DocumentPDF of Interchangeable List
« Back