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


Mogadon 5 mg Tablets



Mylan IRE Healthcare LimitedPA2010/024/001

Main Information

Trade NameMogadon 5 mg Tablets
Active SubstancesNitrazepam
Dosage FormTablet
Licence HolderMylan IRE Healthcare Limited
Licence NumberPA2010/024/001

Group Information

ATC CodeN05CD Benzodiazepine derivatives
N05CD02 nitrazepam

Status

License statusAuthorised
Licence Issued01/04/1977
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceThis product contains a substance listed in schedule 4 Part 1 to the Misuse of Drugs Regulations 2017.
Marketing StatusNot marketed

Documents

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