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


NeoMercazole 20 mg Tablets



Amdipharm LimitedPA1142/002/002

Main Information

Trade NameNeoMercazole 20 mg Tablets
Active SubstancesCarbimazole
Dosage FormTablet
Licence HolderAmdipharm Limited
Licence NumberPA1142/002/002

Group Information

ATC CodeH03BB Sulfur-containing imidazole derivatives
H03BB01 carbimazole

Status

Authorised/WithdrawnAuthorised
Licence Issued13/03/1995
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceCommitment given that... The third PV batch will be manufactured after variation approval and you will notify HPRA in the event of any OOS or atypical data. PV batches will be put on stability and you will notify HPRA if any OOS, or atypical trend is observed, with proposed action.
Marketing StatusMarketed

Documents

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