Risk Minimisation Materials

Important information to assist HCPs in treating patients on MabThera (rituximab) for non-oncology indications

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

For Healthcare Professionals

MabThera (rituximab) – Important information to assist HCPs in treating patients on MabThera for non-oncology indications

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

For Healthcare Professionals

MabThera (rituximab) - Important safety information for patients receiving MabThera for non-oncology indications

The information provided in this booklet should be discussed with patients by their healthcare professional during MabThera (rituximab) treatment. This material is provided by Roche Products Ltd as a licence requirement for this medicine and forms part of the Risk Management Plan.

MabThera (rituximab) in Non-Oncology Indications Patient Alert Card

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

MabThera (rituximab) SC vs IV Use Comparison Card

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

For Healthcare Professionals

MabThera (rituximab) Step by Step Guide for SC use

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

For Healthcare Professionals

Maloff Protect - Pack Size Calculator

A quick reference guide to the appropriate Maloff Protect pack sizes for trips to malaria endemic areas

Maloff Protect - Pharmacy Checklist

A quick guide to the key actions the pharmacist should take before supplying Maloff Protect

For Healthcare Professionals

Maloff Protect - Pharmacy Guide

This guide provides information on the correct choice and usage of the various malaria chemoprophylaxis, including Maloff Protect

For Healthcare Professionals

Maloff Protect - Pharmacy Screening Questionnaire and Explanatory Sheet

A screening questionnaire which the pharmacist can fill out with the customer. It is accompanied by some explanatory notes and together these will help the pharmacist understand if Maloff Protect is suitable for the customer.

For Healthcare Professionals

Maloff Protect - User Reminder Card

Along with the User Reminder App, customers can use this Reminder Card to plan their Maloff Protect dosing

Transdermal fentanyl (“patches”)

Reminder of the potential risk of life-threatening harm from accidental exposure

For Healthcare Professionals

MAVENCLAD 10 mg Tablets (cladribine) - Patient Guide

MAVENCLAD 10 mg Tablets (cladribine) - Patient Guide - Important information on minimising the risk of adverse events

MAVENCLAD 10 mg Tablets (cladribine) - Prescriber's Guide

MAVENCLAD 10 mg Tablets (cladribine) - Prescriber's Guide - Important information on minimising the risk of adverse events

For Healthcare Professionals

Methylphenidate (MPH): physician's guide to prescribing

Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.

For Healthcare Professionals

Physician's Guide to Prescribing Methylphenidate Hydrochloride

Prescribing checklist before prescribing methylphenidate hydrochloride and checklist for ongoing monitoring

For Healthcare Professionals

CHCs ANNEX 1_Direct HCP Communication

Direct Healthcare Professional Communication, to inform of the results of a Europe-wide review and the latest evidence on the risk of thromboembolism in association with certain combined hormonal contraceptives (CHCs).

For Healthcare Professionals

CHCs ANNEX 2_Checklist for Prescribers

Combined Hormonal Contraceptives - checklist for prescribers.

For Healthcare Professionals

CHCs ANNEX 3_Risk of Blood Clots with CHCs

Important Information for women about risk of blood clots with combined hormonal contraceptives.

CHCs ANNEX 4_CHCs Important Info for Women

Combined hormonal contraceptives: important information for women.

Mintreleq XL (Quetiapine MR) Risk Management Plan for Healthcare Professionals

Information for Healthcare Professionals to help inform patients, their families, and their caregivers about the benefits and the risks associated with quetiapine treatment.

For Healthcare Professionals

Physician's Guide: Mircera Important Safety Information

To minimise the risk of pure red cell aplasia. This material is provided by Roche Products Ltd and forms part of the risk management plan.

For Healthcare Professionals

MODECATE® Injection 25mg/ml and MODECATE® Concentrate Injection 100mg/ml - (Fluphenazine Decanoate), Direct Healthcare Professional Communication

Permanent discontinuation of supply for MODECATE® Injection 25mg/ml and MODECATE® Concentrate Injection 100mg/ml - (Fluphenazine Decanoate) by the end of 2018

For Healthcare Professionals

Mucodyne Paediatric Syrup 250 mg/5 mL (Carbocisteine Oral Liquid) DHPC letter

Mucodyne Paediatric Syrup 250 mg/5 mL (Carbocisteine Oral Liquid): new double-strength presentation - check dose volume to ensure appropriate dose is given

For Healthcare Professionals

Multaq - Prescriber Guide

Checklist to assist when prescribing dronedarone. For hard copies please contact our medical information department at 0845 372 7101 or email [email protected]

For Healthcare Professionals

Multaq- HCP Risk management plan letter

Multaq- HCP Risk management plan letter For hard copies please contact our medical information department at 0845 372 7101 or email [email protected]

For Healthcare Professionals

Mycamine (micafungin) Prescriber Checklist

This checklist reminds prescribers about certain aspects of Mycamine to ensure the product is prescribed appropriately. For complete prescribing information, please refer to the Summary of Product Characteristics. When completing the checklist, please tick the boxes that apply and file the completed checklist in the patient's notes.

For Healthcare Professionals

Health Care Professionals Guide - Risk of teratogenicity

Health Care Professionals Guide - Risk of teratogenicity

Health Care Professionals Guide - Risk of teratogenicity

Health Care Professionals Guide - Risk of teratogenicity

For Healthcare Professionals

Important Safety Information - Mycophenolate Risks of Miscarriage and Birth Defects

The letter received to support the two educational guides on the risk of teratogenicity from Mycophenolate Mofetil.

Important Safety Information - Mycophenolate Risks of Miscarriage and Birth Defects

The letter received to support the two educational guides on the risk of teratogenicity from Mycophenolate Mofetil.

Patient Guide - Risk of miscarriage and birth defects

Patient Guide - Risk of miscarriage and birth defects

Patient Guide - Risk of miscarriage and birth defects

Patient Guide - Risk of miscarriage and birth defects

Mycophenolate Mofetil (Myfenax) Guide for Healthcare Providers

This Guide has been designed to highlight the risks to babies associated with exposure to mycophenolate during pregnancy and to minimise the number of pregnancies during treatment with this teratogenic medicinal products. Use this guide during, discussion with the patient to address any questions or concerns the patient may have. Although this Guide presents important information concerning the adverse pregnancy outcomes associated with mycophenolate, please consult the Summary of Product Characteristics (SmPC) for full information on mycophenolate.

For Healthcare Professionals

Mycophenolate mofetil (Myfenax): risks of miscarriage and birth defects Patient Guide

This guide will help you to remember the information you have discussed with your doctor. Keep it so that you can refer to it again. Also, read the package leaflet supplied with your medicine for full information on mycophenolate mofetil.

Health Care Professionals Guide - Risk of teratogenicity

Health Care Professionals Guide - Risk of teratogenicity

For Healthcare Professionals

Important Safety Information - Mycophenolate: Risks of Miscarriage and Birth Defects

The letter received to support the two educational guides on the risk of teratogenicity from Mycophenolate Mofetil.

Patient Guide - Risk of miscarriage and birth defects

Patient Guide - Risk of miscarriage and birth defects

Health Care Professionals Guide - Risk of teratogenicity

Health Care Professionals Guide - Risk of teratogenicity

Important Safety Information - Mycophenolate Risks of Miscarriage and Birth Defects

The letter received to support the two educational guides on the risk of teratogenicity from Mycophenolate Mofetil.

Patient Guide - Risk of miscarriage and birth defects

Patient Guide - Risk of miscarriage and birth defects

Myfortic (Mycophenolic acid) - Guide for Healthcare Providers - Risk of teratogenicity

This guide has been designed to highlight the risks associated with exposure to mycophenolate during pregnancy, as well as the measures that should be taken to mitigate them.

For Healthcare Professionals

Myfortic (mycophenolic acid) - Guide for Patients - Information about the risks to the unborn baby

This guide is about the risks of mycophenolate for the unborn baby, and the ways to reduce these risks.

Myozyme (alglucosidase alfa) - Safety Information Packet (SIP) - Risk Minimisation Information for Healthcare Professionals

Guidance for healthcare professionals on risks associated with Myozyme (alglucosidase alfa) administration, clinical risk management and immunology testing.

For Healthcare Professionals

Physician Prescribing Checklist

This checklist is provided by Orexigen Therapeutics Ireland Limited as a requirement under the terms of the marketing authorization for this medicine. This prescriber guide is a reminder of the indication, contraindications, warnings and precautions as well as the patient characteristics that may place patients at higher risk of adverse reactions to Mysimba. This will help ensure appropriate patient selection and remind physicians of patients who should not be prescribed Mysimba or in whom it should be used with caution. This checklist should be completed prior to initiating therapy with Mysimba.

For Healthcare Professionals