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Singulair Paediatric 5 mg chewable tablets

PCO Manufacturing Ltd.PPA0465/111/002

Main Information

Trade NameSingulair Paediatric 5 mg chewable tablets
Active SubstancesMontelukast sodium
Dosage FormChewable tablet
Licence HolderPCO Manufacturing Ltd.
Licence NumberPPA0465/111/002

Group Information

ATC CodeR03DC Leukotriene receptor antagonists
R03DC03 montelukast


License statusAuthorised
Licence Issued19/01/2007
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceThe authorisation permits the holder to parallel-distribute product marketed in Ireland under the product authorisation number PA1286/046/003 only.
Marketing StatusUnknown


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

Generics Information

Interchangeable List CodeIC0023-001-007
Interchangeable List DocumentPDF of Interchangeable List
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