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Risk Minimisation Materials

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MabThera

Roche Products Limited

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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.

MaloffProtect

Glenmark Pharmaceuticals Europe Ltd

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Maloff Protect - Pack Size Calculator

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

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Maloff Protect - Pharmacy Checklist

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

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Maloff Protect - Pharmacy Guide

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

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Maloff Protect - Pharmacy Screening Questionnaire and Explanatory Sheet

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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.

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Maloff Protect - User Reminder Card

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

Matrifen

Takeda UK Ltd

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Transdermal fentanyl (“patches”)

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

Mavenclad

Merck

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MAVENCLAD 10 mg Tablets (cladribine) - Patient Guide

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Patient Guide - Important information on minimising the risk of adverse events


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

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Prescriber’s Guide - Important information on minimising the risk of adverse events


Mayzent

Novartis Pharmaceuticals UK Ltd

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Mayzent (siponimod) - Pregnancy Reminder Card - for patients

This Pregnancy Reminder Card contains information for female patients of childbearing potential

Methotrexate

ADVANZ Pharma

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Methotrexate Educational Materials for Healthcare Professionals

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Methotrexate Educational Materials for Healthcare Professionals approved by the MHRA

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Methotrexate Patient Card

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card approved by MHRA.

Cipla EU Ltd

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Educational Materials for Healthcare Professionals - Methotrexate

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To minimise the risk of overdose from patients incorrectly taking methotrexate daily instead of once weekly for autoimmune diseases

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Patient Alert Card - Methotrexate

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The Patient Card contains important safety information the patient needs to be aware of when receiving treatment with methotrexate for conditions including arthritis and psoriasis.

Hospira UK Ltd

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Educational Materials for Healthcare Professionals: Medicines containing Methotrexate

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To minimise the risk of overdose from patients incorrectly taking methotrexate daily instead of once weekly for autoimmune diseases

Morningside Healthcare Ltd

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Methotrexate - Educational Materials for Healthcare Professionals - Medicines containing Methotrexate

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To minimise the risk of overdose from patients incorrectly taking methotrexate daily instead of once weekly for autoimmune diseases Medicines containing methotrexate are available in a range of presentations, including: oral tablets, oral solutions, vials for injection, pre‐filled syringes and pens for injection, concentrate for solution for injection.

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Methotrexate Patient Alert Card - Information for Patients

THIS PATIENT CARD IS ONLY INTENDED FOR PATIENTS TAKING METHOTREXATE ONCE A WEEK FOR CONDITIONS INCLUDING ARTHRITIS, PSORIASIS AND CROHN'S DISEASE.

Orion Pharma (UK) Limited

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Educational Materials for Healthcare Professionals - Medicines containing Methotrexate

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A guide for Healthcare Professionals to minimise the risk of overdose from patients incorrectly taking methotrexate daily instead of once weekly for autoimmune diseases.

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Methotrexate Patient Alert Card - Information for Patients

The Patient Card contains important safety information the patient needs to be aware of when receiving treatment with methotrexate for conditions including arthritis and psoriasis.

Rosemont Pharmaceuticals Limited

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Guide for Healthcare Professionals Rosemont Methotrexate 2 mg/ml Oral Solution

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Educational Materials. Guide for Healthcare Professionals Rosemont Methotrexate 2 mg/ml Oral Solution

Sandoz Limited

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Educational materials for Healthcare Professionals - medicines containing Methotrexate

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To minimise the risk of overdose from patients incorrectly taking methotrexate daily instead of once weekly for autoimmune diseases

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Patient Reminder Card - Methotrexate

This Patient Card is only intended for patients taking Methotrexate once a week for conditions including arthritis, psoriasis and Crohn's Disease.

Mexiletine

Clinigen Healthcare Ltd

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Mexiletine Hydrochloride 50, 100 and 200 mg Hard Capsules – HCP guide on minimising the risks of cardiac adverse events and severity of adverse reactions in those with hepatic impairment

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HCP guide on minimising the risks of cardiac adverse events and severity of adverse reactions in those with hepatic impairment


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Mexiletine Hydrochloride 50, 100 and 200 mg Hard Capsules – Patient Alert Card

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Mexiletine hydrochloride 50 mg, 100 mg, 200 mg Hard Capsules contain mexiletine and some patients taking mexiletine may develop cardiac arrhythmia which can be life-threatening. This Patient alert card provides important information to patients about their treatment and aims to raise awareness and inform healthcare providers and pharmacists about the ongoing medication the patient is taking and the risk of cardiac arrhythmia which can be life-threatening.


Mexiletine hydrochloride

Sovereign Medical

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Mexiletine hydrochloride HCP guide

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HCP guide on minimising the risks of cardiac adverse events and severity of adverse reactions in those with hepatic impairment and blood dyscrasias.


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Patient Alert Card

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Mexiletine hydrochloride 100 mg and 200 mg hard capsules contain mexiletine and some patients taking mexiletine may develop irregular heart beats which can be life-threatening. This Patient alert card provides important information to patients about their treatment and aims to raise awareness and inform healthcare providers and pharmacists about the ongoing medication the patient is taking and the risk of cardiac arrhythmia which can be life-threatening.


Micafungin

Wockhardt UK Ltd

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Prescriber Checklist

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Checklist

Microgynon

Bayer plc

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CHCs - Checklist for Prescribers

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Combined Hormonal Contraceptives - checklist for prescribers

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CHCs - Q&A on Important Info for Women

Combined hormonal contraceptives: Q&As about the important information for women.

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CHCs - Risk of Blood Clots with CHCs

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

Microgynon ED

Bayer plc

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CHCs - Checklist for Prescribers

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Combined Hormonal Contraceptives - checklist for prescribers

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CHCs - Q&A on Important Info for Women

Combined hormonal contraceptives: Q&As about the important information for women.

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CHCs - Risk of Blood Clots with CHCs

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

Millinette

Gedeon Richter (UK) Ltd

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Checklist for Prescribers

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Checklist in conjunction with the Summary of Product Characteristics during combined hormonal contraceptive (CHC) consultations.

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Patient User Card

Important information for women about risk of blood clots with combined hormonal contraceptives (CHC).

Mirena

Bayer plc

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Bayer Intrauterine System (IUS) Educational Pack

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Healthcare professional brochure to describe risk of ectopic pregnancy and how to differentiate between Bayer levonorgestrel IUS (LNG-IUS)

Monofer

Pharmacosmos UK Limited

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HCP Educational Material Ferric Derisomaltose

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IV iron. Essential Prescription and Administration Information to Minimise the Risk of Serious Hypersensitivity Reactions

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Patient Educational Material Ferric derisomaltose

Intravenous (IV) Iron. Important Information for Patients about the Possible Risk of Serious Allergic Reactions with IV iron treatment (iron given by injection or infusion into a vein)

Multaq

SANOFI

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Multaq - Prescriber Guide

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MULTAQ® (dronedarone) PRESCRIBER GUIDE

This guide contains important safety information for the safe use of dronedarone.

For hard copies please contact our medical information department at 0800 035 2525 or email [email protected]


Myalepta

Chiesi Limited

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Myalepta (metreleptin) Healthcare Professional Guide

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Healthcare professional guide contains information on the specific risks associated with Myalepta and the measures designed to address them along with the potentially serious adverse drug reactions.


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Myalepta (metreleptin) Patient Care Guide

This document contains important risk minimisation information for patients and their carers.


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Myalepta (metreleptin) Patient Dose Information Card

Provides patients and their carers important information on how to reconstitute and administer Myalepta (metreleptin).


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Myalepta (metreleptin) Specialist Prescriber Guide

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This document contains important risk minimisation information for patients and their carers.


Mycophenolate

Rosemont Pharmaceuticals Limited

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Mycophenolate Guide for Healthcare Professionals

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Mycophenolate Guide for Healthcare Professionals- Information about Risk of Teratogenicity

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Mycophenolate Guide for Patients

Mycophenolate Guide for Patients Information- about risks to the unborn baby

Tillomed Laboratories Ltd

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Mycophenolate mofetil Guide for Healthcare Professionals

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Mycophenolate mofetil Guide for Healthcare Professionals


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Mycophenolate mofetil Guide for Patients

Mycophenolate mofetil Guide for Patients


Mycophenolate mofetil

Teva Pharma B.V.

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Mycophenolate Mofetil (Myfenax) Guide for Healthcare Providers

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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.

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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.

Myfortic

Novartis Pharmaceuticals UK Ltd

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

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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.

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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.

MYNZEPLI

ADVANZ Pharma

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Mynzepli HCP Admin Guide

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RMM Mynzepli UK HCP Admin Guide


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MYNZEPLI patient guide – AMD

RMM MYNZEPLI UK patient guide – AMD


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MYNZEPLI patient guide - DME

RMM MYNZEPLI UK patient guide - DME


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MYNZEPLI patient guide - mCNV

RMM MYNZEPLI UK patient guide - mCNV


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MYNZEPLI patient guide - RVO

RMM MYNZEPLI UK patient guide - RVO


Myozyme

SANOFI

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Myozyme (alglucosidase alfa) - Home Infusion HCP Manual - Risk Minimisation Information

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For hard copies of this information please contact medical information department on 0800 035 2525 or email [email protected]

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

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IMPORTANT INFORMATION for healthcare professionals on risks associated with alglucosidase alfa administration, clinical management of infusion-associated reactions, immune-mediated reactions and immunology testing


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Myozyme (alglucosidase alfa) - Home Infusion Patient and Caregivers Manual - Risk Minimisation Information

For hard copies of this information please contact medical information department on 0800 035 2525 or email [email protected]

Myrin

LIPOMED GmbH

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Information for Healthcare Professionals Prescribing or Dispensing Thalidomide 100mg

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This Information Guide is intended for healthcare professionals involved in the prescribing and dispensing of thalidomide and contains information about the Thalidomide Pregnancy Prevention Programme including risk minimisation measures before prescribing or dispensing thalidomide in order to avoid harm to unborn babies, and other side effects of thalidomide.


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Information for Patients taking Thalidomide 100mg

This Information Guide for patients contains information about the Thalidomide Pregnancy Prevention Programme including risk minimisation measures to avoid harm to unborn babies and how to report side effects.


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Thalidomide 100mg Adverse Event Form

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Thalidomide 100mg Adverse Event Form.


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Thalidomide 100mg Male Risk Awareness Form

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This Risk Awareness Form is to assist healthcare professionals with counselling a patient before they commence thalidomide treatment to ensure patient is fully aware of the risks and the safe use of thalidomide. It must be completed for each male patient before the start of treatment.


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Thalidomide 100mg Patient Card

This card should be given to the patient as a reminder of the most important information and risks of treatment with thalidomide.


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Thalidomide 100mg Pregnancy Outcome Form

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Thalidomide 100mg Pregnancy Outcome Form


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Thalidomide 100mg Pregnancy Report Form

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Thalidomide 100mg Pregnancy Report Form


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Thalidomide 100mg Woman of Childbearing Potential Risk Awareness Form

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This Risk Awareness Form is to assist healthcare professionals with counselling a patient before they commence thalidomide treatment to ensure the patient is fully aware of the risks and the safe use of thalidomide. It must be completed for each female patient of childbearing potential before the start of treatment.


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Thalidomide 100mg Woman of Non-Childbearing Potential Risk Awareness Form

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This Risk Awareness Form is to assist healthcare professionals with counselling a patient before they commence thalidomide treatment to ensure the patient is fully aware of the risks and the safe use of thalidomide. It must be completed for each female patient of non-childbearing potential before the start of treatment.


Mysimba

Orexigen Therapeutics Ireland Limited

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Physician Prescribing Checklist

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The Physician Prescribing Checklist (PPC) for Mysimba® is designed to support appropriate prescribing and ensure safe use of the product among UK healthcare professionals.

Following a previous PASS (Study NB-452) that assessed the effectiveness of the PPC in improving physician knowledge and understanding, a follow-up qualitative study (NB-453) using online focus groups was conducted to explore physician attitudes, understanding, and behaviour related to PPC use.

This follow-up was initiated after some assessment thresholds were not fully met in the initial study. The final results of Study NB-453, along with the updated Risk Management Plan (RMP v.12.10), have been approved to support ongoing risk minimisation efforts.


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