Safety Materials

Products

Safety Materials

These materials have been approved and / or notified to regulatory authorities. Please use the material for your respective country.

These materials are not intended to condition the prescription, use, promotion, sale, recommendation, indication or approval of any Roche product or any concession of benefits to Roche.

Pharmacovigilance

Roche always makes sure to ensure the effectiveness of its medical treatments. If you know of any adverse event due to the use of Roche medicines, please contact us.

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Risk Minimization

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Erivedge®
Version: RMP 8.0 / ARMM 2.0

This activity to minimize risks to public health consists in a Pregnancy Prevention Program designed to minimize the risk of teratogenicity and provide education on the risk of teratogenicity and the recommended contraceptive measures to prevent fetal exposure. The objectives are to prevent exposure to vismodegib in pregnant women and inform patients of the teratogenic risks to the fetus that are associated with vismodegib use.

Patient Counseling Guideline

Reminder for Healthcare Providers

Patient Reminder Card (exclusive for Aruba)

Patient Reminder Card (exclusive for Jamaica)

Patient Reminder Card (exclusive for Curacao)

Patient Reminder Card (exclusive for Trinidad and Tobago)

Patient Reminder Card (exclusive for Anguilla, Antigua and Barbuda, Bahamas, Barbados, Belice, Bermuda, Cayman Islands, Dominica, Grenada, Guyana, Saint Lucia, Turks and Caicos Islands)
Hemlibra®
The objective of the material is to intensify communication and education in patients about the significant potential risk of bleeding / hemorrhage that threatens their lives; due to misinterpretation of standard coagulation examinations or tests, which are not reliable in patients treated with Emicizumab.

Healthcare Professional Guide

Patient Card Guide (exclusive for Aruba)

Patient Card Guide (exclusive for Curacao)

Patient Card Guide (exclusive for Sint Maarten)

Patient Card Guide (exclusive for Trinidad & Tobago)

Patient Card Guide (exclusive for Anguilla, Antigua and Barbuda, Bahamas, Barbados, Belice, Bermuda, Cayman Islands, Dominica, Grenada, Guyana, Saint Lucia, Turks and Caicos Islands)

Patient Carer Guide (exclusive for Aruba)

Patient Carer Guide (exclusive for Curacao)

Patient Carer Guide (exclusive for Sint Maarten)

Patient Carer Guide (exclusive for Trinidad & Tobago)

Patient Carer Guide (exclusive for Anguilla, Antigua and Barbuda, Bahamas, Barbados, Belice, Bermuda, Cayman Islands, Dominica, Grenada, Guyana, Saint Lucia, Turks and Caicos Islands)
MabThera® SC
Version: RMP 8.0 / ARMM 2.0

Objective: This material aims to remind healthcare professionals about the correct technique for administering the MabThera SC, its storage; as well as emphasizing the differences in packaging between the intravenous and subcutaneous formulation, in order to minimize the possibility of medication errors. Finally, we wish to highlight that the subcutaneous formulation is approved only for the use of Non-Hodgkin's Lymphoma. All the information contained in the material is indicated in the label and approved by the Health Authority.

Guide for the supply, storage, handling and administration of MabThera SC to patients with Non-Hodgkin Lymphoma (NHL)
Roaccutane®
Version: RMP 4.0 / ARMM 3.0

This activity to minimize risks to public health aims to remind patients that Roaccutane® is totally contraindicated in women with the potential to have children unless the patient with the condition of the Pregnancy Prevention Program (PPP) as detailed in the product information. To avoid fetal exposure to Roaccutane®, providing educational materials to patients prescribed Roaccutane® to reinforce patient’s understanding of the risk of birth defects and key elements of the PPP such as the critical importance of effective contraception methods while taking Roaccutane®.

Physician Checklist

Pharmacist Checklist - Guidance for dispensing

Patient Reminder Card (exclusive for Aruba)

Patient Reminder Card (exclusive for Bahamas, Barbados, Bermuda, Antigua and Barbuda, Cayman Islands, Grenada, Saint Lucía)

Patient Reminder Card (exclusive for Curacao)

Patient Reminder Card (exclusive for Haití)

Patient Reminder Card (exclusive for Jamaica)

Patient Reminder Card (exclusive for Sint Maarten)

Patient Reminder Card (exclusive for Trinidad & Tobago)
Vabysmo®
Version: RMP 3.0 / ARMM 2.0

Objetive: This material aims to inform patient/carers adequately on the risks, the key signs and symptoms of those risks, and when to seek urgent attention from their physician with the objective to minimize the important identified risks of infectious endophthalmitis and intraocular inflammation; and to promote communication between the patient and their physician.

Faricimab guide for patients (exclusive for Curacao)

Faricimab guide for patients (exclusive for Jamaica)

Faricimab guide for patients (exclusive for Trinidad & Tobago)

Faricimab guide for patients (exclusive for Guyana)

Faricimab guide for patients (exclusive for Antigua and Barbuda, Bahamas, Barbados, Bermuda, Cayman Islands, Grenada, Saint Lucia, Turks and Caicos Islands)

Faricimab guide for patients (exclusive for Aruba)

Audio version: Faricimab guide for patients (exclusive for Aruba, Guyana, Curacao, Jamaica, and Trinidad & Tobago) _{M-AI-00000678}
Audio version: Faricimab guide for patients (Antigua and Barbuda, Bahamas, Barbados, Bermuda, Cayman Islands, Grenada, Saint Lucia, Turks and Caicos Islands) _{M-AI-00000678 v3.0}

Safety Communication Letters

Here you will find Security Letters issued from January 2014 to date:

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