Risk Minimisation Materials (e.g. educational brochures, patient alert cards, posters etc) are intended to improve the use of a medicine by positively influencing health professionals and patients to reduce the risk and/or the severity of adverse reactions associated with a particular medicine.
These materials are additional to the medicine’s Summary of Product Characteristics and Patient Information Leaflet (http://www.medicines.ie) and their requirements are part of the product EU Risk Management Plan.
Only some medicines have a set of tailored risk minimisation materials developed for this purpose. These materials are reviewed and approved by the Health Products Regulatory Authority (HPRA). To access risk minimisation materials (where available electronically) for our medicines, please click on the link below to the HPRA website. Please note: after clicking link below you will then need to use the alphabet search function to access a medicine's risk minimisation materials.
When you click on the hyperlink below you will be moving away from a BMS website to a website for which BMS has no responsibility.
If you would like a hard copy of a BMS medicine's risk minimisation materials posted out to you, please contact Bristol-Myers Squibb Medical Information (telephone:
1 800 749 749; e-mail: email@example.com) with your specific request.
Healthcare professionals: Reporting of 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 Freepost, HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: firstname.lastname@example.org. Adverse reactions should also be reported to Bristol-Myers Squibb Medical Information on 1 800 749 749 or email@example.com
Patients: 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 the package leaflet. You can also report side effects directly via Freepost, HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: firstname.lastname@example.org. By reporting side effects you can help provide more information on the safety of this medicine. Side effects should also be reported to Bristol-Myers Squibb Medical Information on 1 800 749 749 or email@example.com
Bristol-Myers Squibb Ireland, Watery lane, Swords, Co. Dublin.
Phone: 1800 749 749
Approval Number: 466IE1600233-01
Approval Date: September 2016