Imnovid * Pharmacy Only: Prescription
Company:
Bristol-Myers Squibb Pharma EEIGStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Educational materials 'FOR HEALTHCARE PROFESSIONALS' (HCPs) are additional risk minimisation measures that are intended to promote the safe and effective use of the medicinal product.
(Click to Download) Information for Healthcare Professionals
Risk Minimisation Materials
(Click to Download) Physician Registration Form
Risk Minimisation Materials
(Click to Download) Physicians Guide to Prescribing
Risk Minimisation Materials
(Click to Download) Community Pharmacy Dispensing Notification Form
Risk Minimisation Materials
(Click to Download) Prescription Authorisation Form
Risk Minimisation Materials
(Click to Download) Male Treatment Initiation Form
Risk Minimisation Materials
(Click to Download) Woman of Childbearing Potential Treatment Initiation Form
Risk Minimisation Materials
(Click to Download) Woman of Non-Childbearing Treatment Initiation Form
Risk Minimisation Materials
(Click to Download) Pharmacy Registration Form
Risk Minimisation Materials
(Click to Download) Pharmacists Guide to Dispensing
Risk Minimisation Materials
(Click to Download) Order Form
Risk Minimisation Materials
(Click to Download) Adverse Event Form
Risk Minimisation Materials
(Click to Download) Pregnancy Report Form
Risk Minimisation Materials
(Click to Download) Pregnancy Outcome Form
Risk Minimisation Materials
(Click to Download) Treatment Checklists and Algorithm
Risk Minimisation Materials
(Click to Download) Healthcare Professional Information Pack
Risk Minimisation Materials
Educational materials are additional risk minimisation measures that are intended to promote the safe and effective use of the medicinal product. While the approved product information (the Summary of Product Characteristics, Package Leaflet and labelling on the medicine) provides all relevant information on the medicinal product, educational materials focus on one or more specific safety concerns related to use of the medicinal product so as to provide clear information on these specific risks and describe concisely what actions are required to prevent and minimise such risks.
Educational materials may be intended for healthcare professionals (e.g. doctors, pharmacists and nursing staff) and/or patients and care-givers. For example, educational materials may outline what a doctor needs to consider before prescribing a medicine for their patient, or what specific monitoring (e.g. regular blood tests) is required while their patient is on that medicine. Likewise, educational materials may help in reminding patients about important safety information that they need to be aware of before and during treatment with a medicine so that they use the medicine safely and effectively. They may also provide advice to patients on when to seek medical advice. Examples of educational materials for healthcare professionals include healthcare professional guides, dosing and administration guides, prescriber checklists and monitoring charts. Examples of educational materials directed at patients include patient alert cards, patient guides and patient reminder cards.
Educational materials are produced and distributed by the Marketing Authorisation Holder (MAH) of the medicinal product and are specific to that medicinal product. They are not required for all medicines but rather are provided if it is considered that they will aid in optimising the safe and effective use of the product. The need for educational materials is agreed with the HPRA and be may be decided at the time of approval of the medicinal product or at a later time in the lifecycle of the product.
Only educational materials which have been reviewed and approved by the HPRA are listed on the IPHA website. The materials are published by the MAH responsible for producing them. The materials can be downloaded for use by healthcare professionals and patients.
Please note the IPHA does not provide hard copies of these materials. If hard copies are required, please contact the relevant MAH for the medicinal product (contact details are provided as part of the specific educational materials).