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Risk Minimisation Materials

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Remicade

Janssen-Cilag Ltd (a Johnson & Johnson Company)

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Remicade Patient Reminder Card

This patient reminder card contains important safety information that you need to be aware of before and during treatment with Remicade.

Replagal

Takeda UK Ltd

Revlimid

Bristol Myers Squibb Pharmaceuticals limited

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Revlimid® (lenalidomide) Algorithm

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This Algorithm provides high level steps for prescribing and dispensing of lenalidomide.

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Revlimid® (lenalidomide) Frequently Asked Questions

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The FAQs (Frequently Asked Questions) provides answers to common questions that healthcare professionals may have about the medication.

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Revlimid® (lenalidomide) Healthcare Professional’s Information Pack

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This pack contains the all the additional Risk Minimisation Materials required to prescribe and dispense lenalidomide. It also contains important reporting forms, information for patients, prescribing tools, and the Pharmacy Registration Form. It is a requirement of the Pregnancy Prevention Programme that all healthcare professionals ensure that they have read and understood risk minimisation materials before prescribing or dispensing lenalidomide for any patient.

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Revlimid® (lenalidomide) Information for Healthcare Professionals

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This brochure contains the information needed for prescribing and dispensing of lenalidomide, including information about the Pregnancy Prevention Programme. It is a requirement of the Pregnancy Prevention Programme that all healthcare professionals ensure that they have read and understood risk minimisation materials before prescribing or dispensing lenalidomide for any patient. Please also refer to the Summary of Product Characteristics (SmPC) for lenalidomide.

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Revlimid® (lenalidomide) Information for Patients

This brochure should be given to patients receiving treatment with lenalidomide, as it provides important information about the lenalidomide Pregnancy Prevention Programme, including what a patient needs to be aware of before, during and after taking lenalidomide and how to report side effects.

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Revlimid® (lenalidomide) Male Risk Awareness Form

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This Risk Awareness Form must be completed for each male patient prior to the initiation of their lenalidomide treatment. It is mandatory that male patients receive counselling and education to be made aware of the risks of lenalidomide. The aim of the Risk Awareness Form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse effects associated with the use of lenalidomide.

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Revlimid® (lenalidomide) Patient Pocket Information Card

This card should be given to all patient as it reminds patients of the key educational information and risks of treatment with lenalidomide.

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Revlimid® (lenalidomide) Pharmacy Registration Form

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This Pharmacy Registration Form must be completed by the Chief Pharmacist or appointed deputy to be able to order and dispense lenalidomide. In order to ensure that the actions to minimise the risk of foetal exposure are carried out for all patients, dispensing of lenalidomide will only be allowed from pharmacies registered with BMS.

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Revlimid® (lenalidomide) Prescription Authorisation Form

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A newly completed Prescription Authorisation Form must accompany each lenalidomide prescription to confirm that the patient has been counselled about the teratogenic risk of lenalidomide and the required contraceptive methods, continues to use effective contraception and in the case of a woman of childbearing potential, is having a pregnancy test every 4 weeks before each prescription to ensure they are not pregnant. Completion of this information is mandatory for ALL patients.

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Revlimid® (lenalidomide) Woman of Childbearing Potential Risk Awareness Form

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This Risk Awareness Form must be completed for each woman of childbearing potential prior to the initiation of their lenalidomide treatment. It is mandatory that women of childbearing potential receive counselling and education to be made aware of the risks of lenalidomide. The aim of the Risk Awareness Form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse effects associated with the use of lenalidomide.

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Revlimid® (lenalidomide) Woman of Non-Childbearing Potential Risk Awareness Form

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This Risk Awareness Form must be completed for each woman of non-childbearing potential prior to the initiation of their lenalidomide treatment. It is mandatory that women of non-childbearing potential receive counselling and education to be made aware of the risks of lenalidomide. The aim of the Risk Awareness Form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse effects associated with the use of lenalidomide.

Rimmyrah

Orion Pharma (UK) Limited

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Rimmyrah CNV educational materials

Important safety information for patients treated with: RIMMYRAH (ranibizumab) with visual impairment due to choroidal neovascularisation (CNV) secondary to pathological myopia

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Rimmyrah nAMD educational materials

Important safety information for patients treated with: RIMMYRAH (ranibizumab) in wet (neovascular) age related macular degeneration (nAMD)

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Rimmyrah PDR/DMO educational materials

Important safety information for patients treated with: RIMMYRAH (ranibizumab) with proliferative diabetic retinopathy (PDR) and/or visual impairment due to diabetic macular oedema (DMO)

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Rimmyrah RVO educational materials

Important safety information for patients treated with: RIMMYRAH (ranibizumab) with visual impairment due to retinal vein occlusion (RVO)

Rinvoq

AbbVie Ltd

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RINVOQ HCP Guide

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Rinvoq Healthcare Professional Educational Guide

Rivaroxaban

Amarox Limited

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Rivaroxaban Prescriber Guide

Rivaroxaban Prescriber Guide

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Rivaroxaban-Patient Alert Card

Rivaroxaban-Patient Alert Card

Aspire Pharma Ltd

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Rivaroxaban Patient Alert Card

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Rivaroxaban Patient Alert Card

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Rivaroxaban Prescriber Guide for HealthCare Professionals

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Rivaroxaban Prescriber Guide for HealthCare Professionals

Celix Pharma Ltd

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Rivaroxaban patient alert card

Rivaroxaban patient alert card

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RIVAROXABAN PRESCRIBER GUIDE

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Rivaroxaban prescriber guide

Dr. Reddy's Laboratories (UK) Ltd

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Rivaroxaban Prescriber Guide

Rivaroxaban Prescriber Guide

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Rivaroxaban-Patient Alert Card

Rivaroxaban-Patient Alert Card

Genus Pharmaceuticals

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Rivaroxaban - Patient Alert Card

Patient alert card for Rivaroxaban – noting patient’s anticoagulation treatment

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Rivaroxaban – Prescriber Guide

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Guide for Healthcare Professionals

Glenmark Pharmaceuticals Europe Ltd

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Patient Alert Card

Information on anticoagulation treatment with Rivaroxaban film-coated tablets

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Rivaroxaban Prescriber Guide

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Important risk minimisation information for healthcare professionals

Krka UK Ltd

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Rivaroxaban Patient Alert Card

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A patient alert card is provided with the product package to each patient who is prescribed Rivaroxaban. Prescribers are to explain the implications of anticoagulant treatment to patients and/or caregiver, in particular highlighting the need for: • Treatment compliance • Recognising signs or symptoms of bleeding • When to seek medical attention • The need to inform HCPs that they are taking rivaroxaban if they need to have any surgery or invasive procedure. The patient alert card will inform treating physicians and dentists about the patient‘s anticoagulation treatment and will contain emergency contact information.

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Rivaroxaban Prescriber Guide

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This guide is to be used to support the appropriate use of Rivaroxaban. It includes the following information: • Dosing recommendations • Oral intake • Perioperative management • Contraindications • Overdose • How to manage bleeding complications • Coagulation testing

MSN Laboratories Europe Ltd

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Rivaroxaban Patient Alert Card

Rivaroxaban Patient Alert Card


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Rivaroxaban Prescriber Guide

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Rivaroxaban Prescriber Guide


Mylan

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Rivaroxaban Patient Alert Card

Rivaroxaban Patient Alert Card

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Rivaroxaban Prescriber Guide

Rivaroxaban Prescriber Guide

Sandoz Limited

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Rivaroxaban Patient Alert Card ( 10, 15 and 20mg)

A patient alert card is provided with the product package to each patient who is prescribed Rivaroxaban. Prescribers are to explain the implications of anticoagulant treatment to patients and/or caregiver, in particular highlighting the need for: • Treatment compliance • Recognising signs or symptoms of bleeding • When to seek medical attention • The need to inform HCPs that they are taking rivaroxaban if they need to have any surgery or invasive procedure. The patient alert card will inform treating physicians and dentists about the patient‘s anticoagulation treatment and will contain emergency contact information.

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Rivaroxaban Patient Alert Card (2.5 mg)

A patient alert card is provided with the product package to each patient who is prescribed Rivaroxaban. Prescribers are to explain the implications of anticoagulant treatment to patients and/or caregiver, in particular highlighting the need for: • Treatment compliance • Recognising signs or symptoms of bleeding • When to seek medical attention • The need to inform HCPs that they are taking rivaroxaban if they need to have any surgery or invasive procedure. The patient alert card will inform treating physicians and dentists about the patient‘s anticoagulation treatment and will contain emergency contact information.

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Rivaroxaban Prescriber Guide

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This guide is to be used to support the appropriate use of Rivaroxaban. It includes the following information: • Dosing recommendations • Oral intake • Perioperative management • Contraindications • Overdose • How to manage bleeding complications • Coagulation testing

Teva UK Limited

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Rivaroxaban Patient Alert Card

Rivaroxaban Patient Alert Card

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Rivaroxaban Prescriber Guide

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Rivaroxaban Prescriber Guide

Wockhardt UK Ltd

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Rivaroxaban Prescriber Guide

Rivaroxaban Prescriber Guide

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Rivaroxaban-Patient Alert Card

Rivaroxaban-Patient Alert Card

Zentiva

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Rivaroxaban Patient Alert Card - 2.5mg, 10mg, 15mg, 20mg

Rivaroxaban Patient Alert Card - 2.5mg, 10mg, 15mg, 20mg

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RIVAROXABAN PRESCRIBER GUIDE

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RIVAROXABAN PRESCRIBER GUIDE

Rivastigmine Luye

Luye Pharma Limited

Rixathon

Sandoz Limited

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Rixathon (rituximab) - IV administration only

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A healthcare professional card highlighting the route of administration for Rixathon Healthcare Professional

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Rixathon (rituximab) Healthcare Professional Educational Leaflet - Important safety information for healthcare professionals in treating patients with Rixathon therapy

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This guide is intended to review key facts and important safety information about rituximab in non-oncology diseases and to provide important patient counselling information to assist healthcare professionals in caring for patients receiving rituximab therapy.

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Rixathon (rituximab) Patient Educational Leaflet - Important safety information for patients receiving Rixathon therapy

The information provided in this booklet should be discussed with patients by their healthcare professional during Rixathon(rituximab) treatment.

Roaccutane

Roche Products Limited

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Roaccutane (oral isotretinoin) Acknowledgement of Risk Form

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This material is provided by Roche Products Ltd as a license requirement for this medicine and forms part of the Risk Management Plan

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Roaccutane (oral isotretinoin) Patient Reminder Card

This material is provided by Roche Products Ltd as a license requirement for this medicine and forms part of the Risk Management Plan

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Roaccutane (oral isotretinoin) Pharmacist Checklist

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This material is provided by Roche Products Ltd as a license requirement for this medicine and forms part of the Risk Management Plan.

RoActemra

Roche Products Limited

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RoActemra (tocilizumab) Healthcare Professional Brochure

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This material is provided by Roche Products Ltd as a licence requirement for this medicine and forms part of the Risk Management Plan.

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RoActemra (tocilizumab) Important Safety Information for Patients

This material is provided by Roche Products Ltd as a licence requirement for this medicine and forms part of the Risk Management Plan.

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RoActemra (tocilizumab) Patient Card

This material is provided by Roche Products Ltd as a licence requirement for this medicine and forms part of the Risk Management Plan.

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RoActemra Dosing Guide for RoActemra (tocilizumab) intravenous (IV) and subcutaneous (SC) formulations

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This material is provided by Roche Products Ltd as a licence requirement for this medicine and forms part of the Risk Management Plan.

Ruconest

Pharming Group N.V.

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HCP checklist

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Healthcare professional educational material / checklist

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HCP instructions - Immunological Assessments

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Non-promotional educational materials of Immunological Assessments for the Healthcare Professional

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Patient card

Patient card

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Patient checklist

Patient educational material / checklist

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Patient diary

Patient diary

Ruxience

Pfizer Limited

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Ruxience Healthcare professional guide

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Provides guidance on the route of administration (intravenous only), management, monitoring and safety considerations related to the risk management plan.

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Ruxience Patient Alert Card

Provides help to patients to understand the risks associated with Ruxience and reminds them to seek immediate medical attention if they experience any of the listed signs and symptoms.

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Ruxience Patient Brochure

Provides information to patients on the risks, signs and symptoms of infection and the need to contact their doctor immediately if they experience them.

Rybrevant

Janssen-Cilag Ltd (a Johnson & Johnson Company)

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Rybrevant -Important Risk Minimisation Information-Guide to Dosing and Administration

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Information to provide guidance on Dosing and Administration of Rybrevant including Dosing Schedules and Modifications.

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