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Risk Minimisation Materials

Search by company, common medicine name, or title of Risk Minimisation Material

Baricitinib

Eli Lilly and Company Limited

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Baricitinib Lilly 2 and 4 mg Film-Coated Tablets guidance for Healthcare Professionals for Rheumatoid Arthritis

Important risk minimisation information for healthcare professionals prescribing Baricitinib Lilly (baricitinib)

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Baricitinib Lilly 2 and 4 mg Film-Coated Tablets Patient Alert Card

Patient Alert Card containing important safety information for patients.

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Baricitinib Lilly 2 mg and 4 mg Film-Coated Tablets guidance for Healthcare Professionals for Atopic Dermatitis and Alopecia Areata

Risk minimisation for healthcare professionals prescribing Baricitinib Lilly

Bavencio

Merck

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Bavencio 20 mg/ml concentrate for solution for infusion (avelumab) – Patient Alert Card

Proposed changes are:

• removal of the patient information brochure from the educational material, following

the PRAC assessment report PSUSA/00010635/202303

• removal of the black symbol and explanatory statements for medicinal products subject

to additional monitoring

• aligned terminology with the RMP for the term "immune-related" versus "immunemediated.

• additional editorial changes introduced by MAH.

Please find attached latest approved Patient alert card with marked changes and in clean

version.

Bekemv

Amgen Ltd

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BEKEMV Patient Safety Card

Important Safety Information for Patients Receiving BEKEMV and showing this card to any doctor involved in your care.

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BEKEMV Patient/Parent Information Brochure

This guide is for adult patients and parents/legal guardians of a child (above 2 years) who has been prescribed eculizumab. The guide provides you with important safety information that you must be aware of.

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BEKEMV Physician Guide

The aim of this brochure is to educate and/or remind healthcare professionals about the selected prevention measures, detection, careful monitoring and/or proper management of selected safety concerns associated with eculizumab.

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BEKEMV Vaccination Certificate

Drug distribution will only be possible after written confirmation that the patient received or will receive meningococcal vaccination and/or antibiotic prophylaxis from the healthcare providers

Belkyra

AbbVie Ltd

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Injector's Guide For The Safe Use Of Belkyra

This guide provides important information on the safe and effective use of BELKYRA (deoxycholic acid) in order to minimise the risk of injection site nerve injury and associated motor neuropraxia, injection site skin ulceration and necrosis. The guide contains: 1. Information on how to report suspected adverse drug reactions 2. Figures to show anatomical structures of the neck/ key anatomic landmarks of the cervicomental region/ submental fulness scale 3. Checklist for the administration of Belkyra 4. Procedure checklist

Benepali

Biogen Biosimilars

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Benepali Patient Card

PC contains important information that patients need to be aware of.

Benilexa

Gedeon Richter (UK) Ltd

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Benilexa One Handed Healthcare Professional Guide

HCP guide to minimise the risk of application errors due to confusion of different types of IUS and to reduce the risk of ectopic pregnancies.

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Benilexa One Handed Patient Card

Update to the Patient Card.

Beovu

Novartis Pharmaceuticals UK Ltd

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Beovu (Brolucizumab) - Patient Guide to Therapy - for patients with visual impairment due to DMO

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Beovu (Brolucizumab) - Patient Guide to Therapy - for patients with visual impairment due to wet AMD

Bimizza

Morningside Healthcare Ltd

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Checklist for Prescribers - Bimizza 150 microgram/20 microgram Tablets

Please use this checklist in conjunction with the Summary of Product Characteristics during combined hormonal contraceptive (CHC) consultations. •Thromboembolism (e.g. deep vein thrombosis, pulmonary embolism, heart attack and stroke) is a rare but important risk with use of a CHC.

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Important Information for Women Leaflet - Bimizza 150 microgram/20 microgram Tablets

All women should understand: the small risk of blood clots with combined hormonal contraceptives; what other conditions increase the risk of a blood clot; the signs and symptoms of a blood clot; and when you need to tell a healthcare professional that you are using a combined hormonal contraceptive. Although the risk is small, blood clots can be serious. This information will help you minimise your risk.

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Patient Alert Card - Bimizza 150 microgram/20 microgram Tablets

IMPORTANT INFORMATION FOR WOMEN ABOUT RISK OF BLOOD CLOTS WITH COMBINED HORMONAL CONTRACEPTIVES

Blenrep

GlaxoSmithKline UK

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Cover Letter – Risk Minimisation Materials

This letter outlines the risk minimisation materials developed to explain the corneal adverse reactions that may occur with belantamab mafodotin treatment and to provide monitoring and management guidance.

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Eye Care Evaluation guide for Physicians and Eye Care Professionals

This guide provides instructions to facilitate communication between prescribers and eye care professionals for corneal monitoring and management of patients receiving treatment with belantamab mafodotin.

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Important Information for Eye Care Professionals: Corneal Adverse Reactions

This guide is to provide eye care professionals with an overview of corneal adverse reactions that may occur with belantamab mafodotin treatment and to explain the important role of eye care professionals in the monitoring and management of patients receiving belantamab mafodotin

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Important Information for Physicians: Management of Corneal Adverse Reactions

This guide is to provide healthcare professionals with an overview of corneal adverse reactions that may occur with belantamab mafodotin treatment and guidance regarding supportive care and dose modifications to manage corneal adverse reactions

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Patient guide: Important information on Understanding the Vision and Eye Changes with treatment

This guide for patients provides an overview of the vision and eye changes that may occur with belantamab mafodotin treatment.

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Patient Wallet Card

This patient wallet card should be given to all patients to record their care team contact details. Patients should carry this card with them at all times.

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Pharmacy Eye Drop wallet Card

This eye drop wallet card should be given to all patients to present to their pharmacist who will help provide preservative-free artificial tears eye drops. Patients should carry this card with them at all times

Blincyto

Amgen Ltd

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BLINCYTO Guide for Nurses

This educational brochure contains important information regarding the administration of BLINCYTO and the risks of medication errors and neurologic events. This educational material is essential to ensure the safe and effective use of the product and appropriate management of the important selected risks and therefore it is advised to be read carefully before administering the medicinal product.To request a copy of the brochure, please contact Amgen Medical Information on +44 (0) 1223 436441

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BLINCYTO Guide for Patients and Caregivers

This educational brochure contains important information you should know before receiving BLINCYTO. This educational material is essential to ensure the safe and effective use of the drug and appropriate management of the important selected risks. Please read it carefully before taking the medicinal product. To request a copy of this guide, please contact Amgen Medical Information on +44 (0) 1223 436441

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BLINCYTO Guide for Pharmacists

This educational brochure contains important information regarding the reconstitution and preparation procedures for blinatumomab. To ensure the safe and effective use of the medicinal product and appropriate management of the important selected risks, please carefully read this material before reconstituting and preparing of the medicinal product.To request a copy of the brochure, please contact Amgen Medical Information on +44 (0) 1223 436441

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BLINCYTO Guide for Physicians

This educational brochure contains important information regarding the administration of BLINCYTO and the risks of medication errors and neurologic events. This educational material is essential to ensure the safe and effective use of the product and appropriate management of the important selected risks and therefore it is advised to be read carefully before prescribing and administering the medicinal product.To request a copy of the brochure, please contact Amgen Medical Information on +44 (0) 1223 436441

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BLINCYTO Patient Alert Card

This BLINCYTO patient alert card contains a warning message for HCPs that the patient is using BLINCYTO, includes contact details of the BLINCYTO prescriber and treatment start date, and information on the importance of reporting ADRs. To request a copy of the patient card, please contact Amgen Medical Information on +44 (0) 1223 436441

Bosentan

Aurobindo Pharma - Milpharm Ltd.

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Bosentan Milpharm - Patient Alert Card

Important Safety Alerts for Patients taking Bosentan Milpharm

Cipla EU Ltd

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Bosentan 62.5 mg and 125 mg film-coated tablets.

Patient alert card

Dr. Reddy's Laboratories (UK) Ltd

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Bosentan 62.5 mg & 125 mg Film-coated Tablets - Patient Alert Card

Bosentan Patient Alert Card

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Bosentan Dr. Reddy's 62.5 mg & 125 mg Film-coated Tablets Patient leaflet Important Safety Information

Important Safety Alerts for Patients Taking Dr. Reddy's Bosentan 62.5 mg & 125 mg Film-coated Tablets

Mylan

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Bosentan Patient Alert Card

Important Safety Alerts for Patients taking Bosentan Mylan (bosentan)

Zentiva

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Bosentan- Patient Alert Guide

This card contains important information about bosentan. Please read this card carefully before starting your treatment with bosentan. For hard copies please contact our medical information department on 0800 090 2408 or email [email protected]

Braltus

Teva UK Limited

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Risk Minimisation Information on Potential Risk of Medication Errors - Guide for HCPs

This educational guide is provided to highlight and minimise the potential risk of prescribing and administration errors (medication errors) due to the differences between Braltus (tiotropium bromide) and the originator product Spiriva® HandiHaler® (tiotropium bromide) with respect to the pre-metered dose.

Brancico

Zentiva

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Brancico XL 50mg, 150mg, 200mg, 300mg and 400mg prolonged-release tablets Educational material for health care professionals

Educational material for health care professionals Brancico XL 50mg, 150mg, 200mg, 300mg and 400mg prolonged-release tablets For hard copies please contact our medical information department at 0800 090 2408 or email [email protected]

Brevinor

Pfizer Limited

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PFIZER CHC Norethisterone or Levonorgestrel VTE and ATE RMM Checklist for prescribers

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PFIZER CHC Norethisterone or Levonorgestrel VTE and ATE RMM Patient card

Breyanzi

Bristol Myers Squibb Pharmaceuticals limited

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Breyanzi (lisocabtagene maraleucel) Healthcare Professional Guide - UK - v1

This educational guide forms part of the additional risk minimisation measures for lisocabtagene maraleucel. It contains information regarding selected lisocabtagene maraleucel-associated adverse reactions of cytokine release syndrome (CRS), neurologic toxicities, including immune effector cell associated neurotoxicity syndrome (ICANS), and secondary malignancy of T-cell origin. These are not all the adverse reactions associated with lisocabtagene maraleucel. Please refer to the lisocabtagene maraleucel SmPC for more information.

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Breyanzi (lisocabtagene maraleucel) Patient Card - UK - v1

The Patient Card is an important document that should be carried by the patient at all times. It contains key information, including symptoms that the patient should be aware of and look out for.

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Breyanzi (lisocabtagene maraleucel) Product Handling and Administration Guide - UK - v1

This guide forms part of the additional risk minimisation measures for lisocabtagene maraleucel. It is intended for healthcare professionals involved in the transport, storage, thawing, preparation, handling, and/or administration of lisocabtagene maraleucel. It provides guidance on the correct procedures for proper handling, thawing, preparation and administration to minimise the potential risk of reduced viability of lisocabtagene maraleucel due to inappropriate product handling.

Brinavess

ADVANZ Pharma

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Appropriate use of Brinavess

Appropriate use of Brinavess (vernakalant hydrochloride) concentrate for solution for infusion

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Brinavess Pre-infusion Checklist

Prior to administration the prescriber is asked to determine eligibility of the patient through use of the supplied checklist. The checklist should be placed on the infusion container to be read by the healthcare professional who will administer BRINAVESS.

Bronchitol

Pharmaxis Europe Limited

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Bronchitol Healthcare Professional Leaflet

Byooviz

Samsung Bioepis UK Limited

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Byooviz Patient Booklet – Treatment of AMD

This booklet is for patients using Byooviz for the treatment of nAMD. The booklet forms part of the patient information pack (educational materials). The booklet provides an overview on how Byooviz works, how treatment is administered and what to expect, the key signs and symptoms of potential adverse reactions and when to seek urgent attention from the physician, ensuring rapid identification and treatment of these events.

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Byooviz Patient Booklet – Treatment of CNV

This booklet is for patients using Byooviz for the treatment of CNV. The booklet forms part of the patient information pack (educational materials). The booklet provides an overview on how Byooviz works, how treatment is administered and what to expect, the key signs and symptoms of potential adverse reactions and when to seek urgent attention from the physician, ensuring rapid identification and treatment of these events.

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Byooviz Patient Booklet – Treatment of PDR-DMO

This booklet is for patients using Byooviz for the treatment of PDR and DMO. The booklet forms part of the patient information pack (educational materials). The booklet provides an overview on how Byooviz works, how treatment is administered and what to expect, the key signs and symptoms of potential adverse reactions and when to seek urgent attention from the physician, ensuring rapid identification and treatment of these events.

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Byooviz Patient Booklet – Treatment of RVO

This booklet is for patients using Byooviz for the treatment of RVO. The booklet forms part of the patient information pack (educational materials). The booklet provides an overview on how Byooviz works, how treatment is administered and what to expect, the key signs and symptoms of potential adverse reactions and when to seek urgent attention from the physician, ensuring rapid identification and treatment of these events.

Risk Minimisation Materials

Baricitinib

Eli Lilly and Company Limited

Bavencio

Merck

Bekemv

Amgen Ltd

Belkyra

AbbVie Ltd

Benepali

Biogen Biosimilars

Benilexa

Gedeon Richter (UK) Ltd

Beovu

Novartis Pharmaceuticals UK Ltd

Bimizza

Morningside Healthcare Ltd

Blenrep

GlaxoSmithKline UK

Blincyto

Amgen Ltd

Bosentan

Aurobindo Pharma - Milpharm Ltd.

Cipla EU Ltd

Dr. Reddy's Laboratories (UK) Ltd

Mylan

Zentiva

Braltus

Teva UK Limited

Brancico

Zentiva

Brevinor

Pfizer Limited

Breyanzi

Bristol Myers Squibb Pharmaceuticals limited

Brinavess

ADVANZ Pharma

Bronchitol

Pharmaxis Europe Limited

Byooviz

Samsung Bioepis UK Limited

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