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Methotrexate 2.5 mg Tablets



Amdipharm LimitedPA1142/030/001

Main Information

Trade NameMethotrexate 2.5 mg Tablets
Active SubstancesMethotrexate
Dosage FormTablet
Licence HolderAmdipharm Limited
Licence NumberPA1142/030/001

Group Information

ATC CodeL04AX Other immunosuppressants
L04AX03 methotrexate

Status

License statusAuthorised
Licence Issued23/05/1983
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceCommitments: Carry out ICH stability studies to full shelf life, providing data to the IMB when available. At least one batch per year is to be placed on stability testing, and any out-of-specification results, or results indicating possible future out-of-specification results, are to be investigated and reported to the IMB immediately.
Marketing StatusMarketed

Documents

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

Generics Information

Interchangeable ListMethotrexate 2.5mg Tablets
Interchangeable List CodeIC0098-018-002
Interchangeable List DocumentPDF of Interchangeable List
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