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Agomelatine Mylan 25 mg film-coated tablets



McDermott Laboratories Ltd., T/A Gerard LaboratoriesPA0577/189/001

Main Information

Trade NameAgomelatine Mylan 25 mg film-coated tablets
Active SubstancesAgomelatine
Dosage FormFilm-coated tablet
Licence HolderMcDermott Laboratories Ltd., T/A Gerard Laboratories
Licence NumberPA0577/189/001

Group Information

ATC CodeN06AX22 agomelatine

Status

License statusAuthorised
Licence Issued26/10/2018
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusMarketed

Documents

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

Educational Materials - HCP

Physicians Guide

Educational Materials - Patient

Patient Guide

Generics Information

Interchangeable ListAgomelatine 25mg Film-coated Tablets
Interchangeable List CodeIC0136-022-003
Interchangeable List DocumentPDF of Interchangeable List
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