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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

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

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

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

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

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

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.

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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)

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RINVOQ HCP Guide

RINVOQ HCP educational guide

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RINVOQ Patient Card

Patient card

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Rivaroxaban Prescriber Guide

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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 patient alert card

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RIVAROXABAN PRESCRIBER GUIDE

Rivaroxaban prescriber guide

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Rivaroxaban Prescriber Guide

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Rivaroxaban-Patient Alert Card

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Rivaroxaban Patient Alert Card

Rivaroxaban Patient Alert Card - Provided to each patient who is prescribed Rivaroxaban Gedeon Richter film coated tablets to inform treating physicians and dentists about the patient‘s anticoagulation treatment.

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Rivaroxaban Prescriber Guide

Rivaroxaban Prescriber Guide - The Prescriber Guide provides recommendations for the use of Rivaroxaban in order to minimise the risk of bleeding during treatment with Rivaroxaban.

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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

Guide for Healthcare Professionals

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Patient Alert Card

Information on anticoagulation treatment with Rivaroxaban film-coated tablets

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Rivaroxaban Patient Alert Card 2.5 mg

Information on anticoagulation treatment with Rivaroxaban film-coated tablets

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Rivaroxaban Prescriber Guide

Important risk minimisation information for healthcare professionals

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Rivaroxaban Prescriber Guide 2.5 mg

Important risk minimization information for healthcare professionals

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Rivaroxaban Patient Alert Card

Patient Alert Card

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Rivaroxaban Prescriber Guide

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

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Rivaroxaban Patient Alert Card

Patient Alert Card

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Rivaroxaban Prescriber Guide

Prescriber Guide

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Rivaroxaban Patient Alert Card

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Rivaroxaban Prescriber Guide

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Rivaroxaban Patient Alert Card

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Rivaroxaban Prescriber Guide

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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

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

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Rivaroxaban Patient Alert Card

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Rivaroxaban Prescriber Guide

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Rivaroxaban Prescriber Guide

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Rivaroxaban-Patient Alert Card

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

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RIVAROXABAN PRESCRIBER GUIDE

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Rivastigmine Luye 4.6 mg, 9.5 mg, 13.3 mg/24 h transdermal patch

Patient Educational Material

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Rixathon (rituximab) - IV administration only

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

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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Risk Minimisation Materials

Remicade

Janssen-Cilag Ltd (a Johnson & Johnson Company)

Remsima

Celltrion Healthcare UK Limited

Replagal

Takeda UK Ltd

Revlimid

Bristol Myers Squibb Pharmaceuticals limited

Rimmyrah

Orion Pharma (UK) Limited

Rinvoq

AbbVie Ltd

Rivaroxaban

Amarox Limited

Aspire Pharma Ltd

Celix Pharma Ltd

Dr. Reddy's Laboratories (UK) Ltd

Gedeon Richter (UK) Ltd

Genus Pharmaceuticals

Glenmark Pharmaceuticals Europe Ltd

Krka UK Ltd

Laboratorios Liconsa, S.A.

MSN Laboratories Europe Ltd

Mylan

Sandoz Limited

Teva UK Limited

Wockhardt UK Ltd

Zentiva

Rivastigmine Luye

Luye Pharma Limited

Rixathon

Sandoz Limited

Roaccutane

Neon Healthcare Ltd

Roche Products Limited

RoActemra

Roche Products Limited

Ruconest

Pharming Group N.V.

Ruxience

Pfizer Limited

Rybrevant

Janssen-Cilag Ltd (a Johnson & Johnson Company)

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