Pharmacovigilance: information on accurate and timely reporting of safety information
Any medicine may cause side effects in some patients. Information on side effects and related risks may be known only after a drug is used in large numbers of patients in the wider population. Historical events have led the community to actively monitor the accurate reporting of safety information relating to the care of people with haemophilia.
Why carry out pharmacovigilance?
- To contribute to the assessment of the risk and benefit of medicines, encouraging their safe and effective use
- To ensure the timely identification of adverse safety events
- To improve patient care and safety
Pharmacovigilance at Roche/Chugai
Patient safety is a top priority for Roche/Chugai and we are committed to monitoring the safety of all our medicines through established reporting mechanisms. The safety risk management process begins in the early stages of a medicine’s development and continues for the entire time the medicine is on the market.
Safety information for events that change the risk–benefit profile of a medicine will be proactively communicated to all healthcare professionals and patient groups, following necessary interactions with the authorities. In addition, there is regular phased communications of safety information, including reporting at congresses and via publications.
Feedback from healthcare professionals on reporting mechanisms is gratefully received as Roche/Chugai works together with the haemophilia community to continuously improve patient care.
Should you need to report an adverse event, please visit Adverse Events Reporting for more information on how to do so.
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing email@example.com or calling +44 (0)1707 367554. As HEMLIBRA® is a biological medicine, healthcare professionals should report adverse reactions by brand and batch number.
Date of preparation: September 2020