From 1 July 2014, MAHs are requested to update section 4.8 of the SmPC and section 4 of the PIL for ADR reporting at the next appropriate regulatory opportunity. This update relates to the inclusion of the Health Products Regulatory Authority (HPRA) name in place of the Irish Medicines Board (IMB) name. For products with no immediate or upcoming regulatory opportunities, MAHs should submit a stand-alone Type IAin variation by 1st July 2015 at the latest, to make this change.
Please see updated text below:
SUMMARY OF PRODUCT CHARACTERISTICS
4.8. Undesirable effects
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.
PACKAGE LEAFLET
4. Possible side effects
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.