<a href="${link:{uuid:{c90870f5-b8bd-4138-bee3-88766d4cee04},repository:{dam},path:{/Portal/UK/Prescribing-links/Clexane-pi.pdf}}}" target="_blank">Prescribing Information UK</a>

<h3>LMWHs, including enoxaparin, are used across a variety of indications.</h3>
LMWHs are complex to manufacture given that they are biological medicines derived from porcine heparin, taking several months (9-10 on average) to produce.
As a result, high levels of investment is needed to meet current and future quality and regulatory standards and to continue to supplying high-quality medicines on a global scale.

<h2>Market dynamics</h2>
<h3>Sanofi has observed that some procurement practices aimed at realizing short-term savings may disrupt the market balance leading to long-term market unsustainability.</h3>
In some cases, this may unintendedly disincentivise manufacturers to supply in certain markets increasing the risk of challenges in the supply chain and medicines shortages. This situation could lead to an overall increase in healthcare expenditure.
In the past demand was more predictable within the LMWH market; this led to a more sustainable market with manufacturers able to maintain continuity of supply and financial stability. Today this market has been impacted by the following issues:&nbsp;
<ul>
 <li>Increased production costs</li>
 <li>Covid-19</li>
 <li>Unsustainable prices</li>
 <li>African Swine Fever</li>
 <li>Voluntary scheme for branded medicines pricing and access (VPAS)</li>
</ul>

Furthermore, with the emergence of biosimilars alongside a continuing pattern of International Non proprietary Names (INN) prescribing, the predictability of demand in this market is becoming ever more complex.
Price-orientated procurement practices also have the potential to increase the&nbsp;availability of parallel imports&nbsp;which could destabilise the supply of LMWHs further.

<table border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
 <tr>
 <td>There is a need for more predictability of demand, particularly considering the long production time and buyer fragmentation observed in the market.</td>
 </tr>
 </tbody>
</table>

Sanofi project the global market to continue growing at approximately 5% per year between 2022-2028.*

<h3>Demand for LMWHs has been increasing over the past 10 years.</h3>

<h2>Supply resilience</h2>
<h3>In recent years, the average procurement cost of pure heparin has increased; (for Sanofi this has more than doubled over the past 5 years) with pure heparin accounting for &gt;50% of Clexane (enoxaparin) production costs.</h3>
Increased global demand for&nbsp;syringes and component parts&nbsp;has also contributed to difficult market conditions.
Currently, these difficult market conditions are exacerbated by&nbsp;global inflation&nbsp;which also increases procurement costs. At the same time, price-centric tendering practices are contributing to an unsustainable situation by commoditizing the LMWH market.
Due to the&nbsp;length of the supply chain and difficulties in accurately forecasting, the industry faces challenges in responding rapidly to changes in procurement policies and demand. Communication between industry and the NHS is essential in matching supply with demand.
Sanofi believe that if the number of suppliers in each market decrease, vulnerabilities in supply chains can become more exposed which&nbsp;increases the strain on remaining suppliers&nbsp;to deliver consistent volumes.
Investment in high-quality manufacturing supported by sustainable procurement practices can strengthen supply chain resilience.

<h2>Sanofi’s commitment</h2>
<h3>By supplying Clexane (enoxaparin) in more than 100 counties over a 30 year period, Sanofi has become the global leader in the supply of LMWHs.</h3>

<h4>Supplying Clexane (enoxaparin) in ~ 100 countries over 30 years</h4>

<h4>~ 70 manufacturing sites for a global supply chain</h4>

<h4>~ 20 R&amp;D sites committed to improving environmental sustainability</h4>

Sanofi also boasts a diversified global supply chain with multiple manufacturing and sourcing sites across Latin America, China and North America, and has the largest EU footprint of any LMWH manufacturer; this diversification, including local manufacturing, helps to support local economies and insulate the market from medicine shortages.&nbsp;
Furthermore, Sanofi is committed to improving environmental sustainability through improved packaging designs, reinvesting in further life cycle management and providing additional services to patients and healthcare systems.&nbsp;
<a href="https://www.sanofi.com/en/media-room/press-releases/2022/2022-03-08-13-25-40-2398922" target="_blank">Read: Sanofi recognized by S&amp;P as one of the most sustainability-committed companies - Sanofi</a>

Sanofi CEO

Paul Hudson

<h2>Case for sustainable procurement</h2>
<h3>As a leading global enoxaparin manufacturer, Sanofi has the expertise to work with authorities across the world. Sanofi is therefore approaching authorities with proposals to overcome the market and supply challenges and ensure patients' access to medicines.</h3>
Sanofi believe that the&nbsp;global LMWH&nbsp;market needs&nbsp;greater supply&nbsp;resilience&nbsp;and long-term&nbsp;sustainable&nbsp;market conditions.
Sanofi is calling for all stakeholders involved in LMWH procurement to find the most appropriate conditions and support long-term market sustainability and patient access striking a balance between fair pricing and healthcare cost optimisation

Pricing recommendations should be tailored to the local market and policy environment and should support market sustainability and patient access

National guidance on sustainable tendering practices should be recommended

Tender designs should reflect the complexities of LMWH and safeguard access to medicines

<h3>National/Regional</h3>
Sanofi asks procurement leads to consider changes to tender structures which increase the emphasis on&nbsp;non-price centric&nbsp;criteria and&nbsp;award multiple suppliers, which will benefit all stakeholders&nbsp;by increasing supply reliability and safeguarding access to these essential medicines. This is in line with the Governments Social Value Model.

<h3>Locally</h3>
Education is required for a&nbsp;greater understanding of sustainable procurement&nbsp;and local&nbsp;decisions should be communicated&nbsp;to all suppliers of LMWH.

If a locality&nbsp;chooses a single supplier, other suppliers cannot be expected to meet additional demand in the event of a shortage.&nbsp;
Alternatively, localities could consider choosing multiple suppliers and providing accurate forecasts of their demand to ensure the availability of products.

In assessing the relative benefits of multiple versus single supplier sourcing, procurement teams should look at:
<ul>
 <li>The pharmacy workforce impact of out of stock situation</li>
 <li>The shortages of tackling elective backlogs&nbsp;</li>
 <li>The green sustainability commitments of any decisions</li>
</ul>

<a href="/uk/thrombosis">SEE MORE FROM SCIENCE</a>

<h2>Get in touch with the Thrombosis Team</h2>

Clexane® (enoxaparin) Prescribing Information UK

THROMBOSIS

CARDIOLOGY

Social value and net zero in NHS procurement

<a href="${link:{uuid:{55f30477-c7e2-49c0-8cfc-16966f28d4c2},repository:{dam},path:{/Portal/UK/Prescribing-links/Praluent-PI-GB-October-2022.pdf}}}" target="_blank">Prescribing Information(GB)</a>

<a href="${link:{uuid:{9e0d6f97-2ebb-4422-92ab-569b89c7dfe0},repository:{dam},path:{/Portal/UK/Prescribing-links/Praluent-PI-NI.pdf}}}" target="_blank">Prescribing Information(NI)</a>

In patients with a prior CV event, Praluent®&nbsp;demonstrated a higher absolute risk reduction in MACE in patients with diabetes than in those with prediabetes or normoglycaemia1*
*Data from a prespecified analysis
~90% of patients in Odyssey Outcomes were on high-intensity statins and 29% of them had diabetes at baseline (99.2% of these had type 2 diabetes run in)2.
In the placebo group, the risk of MACE at median follow-up 2.8 years was approximately twice the risk in patients with diabetes than in patients with normoglycaemia (HR 2.09, 95% CI 1.78–2.46, p&lt;0.0001) or prediabetes (HR 1·90 95% CI 1·65–2·17, p&lt;0.0001)1.

Study design:&nbsp;ODYSSEY OUTCOMES&nbsp;was a randomized, double-blind, placebo-controlled phase 3 study. Patients with a recent MI or unstable angina, and on high-intensity statin (40 or 80 mg atorvastatin or 20 or 40 mg rosuvastatin, or maximally tolerated dose of one of these agents) +/- other lipid-lowering therapy but not at predefined target LDL-C were enrolled. Patients were classified by glycaemic status at baseline (normoglycemia, prediabetes, or diabetes) defined on the basis of patient history, review of medical records, or baseline HbA1c or fasting serum glucose, and risk of new-onset diabetes among those without diabetes at baseline1,2.

PRALUENT®&nbsp;did not increase the risk of new-onset diabetes for patients with prediabetes or normoglycemia at baseline1.

DYSLIPIDEMIA

<a href="/uk/dyslipidaemia">SEE MORE FROM SCIENCE</a>

<h3>Praluent®</h3>
Find more information on Indication, Administration and Mechanism of Action and watch videos about Praluent®.

<h3>Patient Website</h3>
Find resources and support for your patients on Praluent®. Find useful links about how patients can manage their cholesterol.

<h2>Get in touch with the Dyslipidaemia Team</h2>

Praluent® (alirocumab) Prescribing Information (GB)

Praluent® (alirocumab) Prescribing Information (NI)

Cardiovascular outcomes for diabetes patients Praluent® (alirocumab)

<a href="${link:{uuid:{8cd02cf2-bd72-495f-b720-698ef8d3f0da},repository:{dam},path:{/Portal/UK/Prescribing-links/Toujeo.pdf}}}" target="_blank">Prescribing Information Toujeo (insulin glargine 300 units/mL)</a> <a href="${link:{uuid:{8f132346-a5c2-470d-8368-64ab56220e08},repository:{dam},path:{/Portal/UK/Prescribing-links/Lantus_GB_NI_PI.pdf}}}" target="_blank">Prescribing Information Lantus (insulin glargine 100 units/mL)</a>

Ask us your questions about our products, patient materials or organising a meeting.

Sanofi is here to support you and your patients.

<h2>Toujeo®&nbsp;can support your patients with T1DM</h2>
Discover the Toujeo®&nbsp;Evidence in T1DM below and get access to patient supporting tools and materials for your T1 patients who have been prescribed Toujeo®.

<h3>Toujeo®&nbsp;is associated with a more stable and prolonged activity profile over a full 24-hour period than insulin glargine 100 units/mL1</h3>

<h3>Toujeo®&nbsp;is associated with a flatter PK/PD profile vs insulin degludec 100 units/mL2</h3>

Toujeo®&nbsp;has a flatter, more stable activity profile – extending beyond 24 hours with a flexible dosing window (+/- 3 hours).
<ul>
 <li>PK/PD study in people with T1DM using euglycaemic-clamp technique at steady state. The results of euglycaemic clamp studies do not necessarily predict clinical outcomes in all patients.</li>
</ul>

Compared with insulin degludec, Toujeo®&nbsp;at a clinically relevant dose (0.4 units/kg/day) provides a more stable and evenly distributed PK/PD profile with less within-day fluctuation in adults with T1DM.1&nbsp;Toujeo®&nbsp;also had a&nbsp;20% lower (p=0.047)&nbsp;within-day variability&nbsp;of the smoothed GIR curve vs insulin degludec.1
<ul>
 <li>For GIR data a smoothing factor (LOESS factor 0.15) was applied. PK/PD study in people with T1DM using euglycaemic-clamo technique. The results of euglycaemic clamp studies do not necessarily predict clinical outcomes in all patients.</li>
 <li>The within-day variability of the smoother GIR curve was similiar between Toujeo®&nbsp;0.6 units/kg/day and insulin degludec 0.6 units/kg/day. Both insulins provided exposure and acctivity until 30 hours (end of clamp).</li>
</ul>

Study design:&nbsp;Becker RHA,&nbsp;et al. 2015.1
Study aim:&nbsp;to characterise the PK/PD of Toujeo®&nbsp;compared with insulin glargine 100 units/mL at steady state in people with T1DM.
Study design:&nbsp;Single-centre, randomised, double-blind, two-treatment, two-period, two sequence crossover euglycaemic clamp study.
Primary endpoint:&nbsp;GIR and INS profiles in steady state.
Treatment during the washout period was unchanged from that recieved prior to the study. For GIR and BG data a smoothing factor (LOESS factor 0.15) was applied.

Study design:&nbsp;Bailey TS,&nbsp;et al. 2018.2
Study aim:&nbsp;to compare the PK/PD properties of 0.4 and 0.6 units/kg/day Toujeo®&nbsp;with insulin degludec 100 units/mL in people with T1DM
Study design:&nbsp;Single-centre, randomised, double-blind, two-treatment, two-period, two-sequence crossover euglycaemic clamp study
Primary endpoint:&nbsp;Fluctuation (within-day variability) of the smoothed GIR curve over a 24-hour dosing period in steady state (GIR-smFL0-24)*
Treatment during the washout period was unchanged from that recieved prior to the study.&nbsp;For GIR and BG data a smoothing factor (LOESS factor 0.15) was applied.​​
​*The area of the individual smoothed GIR above and below the individual average GIR line is calculated, providing the mean amplitude of GIR fluctuations around the average GIR over 24 hours.​

The clinical implications of PK/PD data require further evaluation including CGM and larger clinical studies.&nbsp;PK/PD study in people with T1DM using euglycaemic-clamp technique at steady state.&nbsp;The results of euglycaemic clamp studies do not necessarily predict clinical outcomes in all patients.

<h2>CGM</h2>
Toujeo®&nbsp;vs Insulin Glargine 100 U/mL3

<h3>Toujeo®&nbsp;vs Insulin Glargine 100 U/mL4</h3>
Post-hoc meta-analysis of three EDITION 6-month, Phase III, randomised clinical trials
Post-hoc meta-analysis aim:&nbsp;Exploring the risk for severe hypoglycaemia with Toujeo®&nbsp;vs insulin glargine 100 units/mL in the pool of studied patients with T1DM.

Edition 4 (549 adults), Edition Junior (463 children), Edition JP 1 (243 adults).

<h3>Toujeo®&nbsp;vs other basal insulins5</h3>

A multicentre, UK, retrospective, observational study to assess the effectiveness of Toujeo®&nbsp;in treating people with Type 1 diabetes mellitus in routine clinical practice (SPARTA).
Primary endpoint:&nbsp;Change in HbA1c levels from baseline to Month 6 after Toujeo®&nbsp;initiation.

298 patients with T1DM were recruited.

<a href="/uk/type-1-diabetes">SEE MORE FROM SCIENCE</a>

<h3>Toujeo</h3>
Toujeo®&nbsp;is indicated as treatment of diabetes mellitus in adults,&nbsp;adolescents and children from the age of 6 years.&nbsp;

<h3>Patient Website</h3>
Find resources and support for your patients on Toujeo®. Help patients understand the basics of living and staying well with diabetes and how to have a positive start and experience with the medication prescribed to them.

Abbreviations

Toujeo® (insulin glargine 300 units/mL) Prescribing Information 

Lantus® (insulin glargine 100 units/mL) Prescribing Information 

TYPE-1-DIABETES

DIABETES

T1 Evidence in Adults

<h2>Indication</h2>
The prophylaxis of venous thromboembolism (VTE):1
<ul>
 <li>In moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery.</li>
 <li>In medical patients with an acute illness and reduced mobility at increased risk of VTE.</li>
</ul>
The treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery:1
<ul>
 <li>Extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer.</li>
 <li>Prevention of thrombus formation in extracorporeal circulation during haemodialysis.</li>
 <li>Acute coronary syndrome:
 <ul>
 <li>Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid.</li>
 <li>Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).</li>
 </ul></li>
</ul>

<h2>Mechanism of action</h2>
Clexane®&nbsp;exerts its anticoagulant effect by preventing the formation of blood clots through binding to antithrombin, a naturally occurring coagulation inhibitor and potentiating its action.2
Antithrombin is a natural inhibitor of the coagulation factors FXIa, FIXa, FXa and FIIa (thrombin).2
Clexane®&nbsp;forms a complex with antithrombin. This complex undergoes a conformational change; in its altered conformation, the complex inhibits FXa, which is the primary mechanism of action. It also inhibits FIIa, although to a lesser extent - in vitro, Clexane has a high anti-Xa activity and low anti-IIa or anti thrombin activity, with a ratio of 3.6 :1.2

Indication and Mechanism of action of Clexane (enoxaparin)

<h2>Managing patients with Gaucher disease</h2>
Managing your patients’ diagnosis doesn’t stop once they’ve received their results. Regardless of their test outcomes, knowing the next steps in their treatment journey can prepare them for the next stages.
<h3>Handling a positive result</h3>
Being diagnosed with Gaucher disease can be a life-changing experience for a patient and may take some time to process. During the early stages after diagnosis, it is important to keep in contact with the patient and ensure they have as many support resources as they need.

<h2>Referral</h2>
Following diagnosis, a patient with confirmed Gaucher disease should be referred to a specialist centre for treatment.
<h3>There are 13 specialist centres across the UK and Ireland, across 8 cities</h3>

<ol>
 <li>Glasgow:&nbsp;Scottish Centre for Metabolic Diseases, Inherited Metabolic Disorders Scotland Managed Clinical Network</li>
 <li>Belfast:&nbsp;Royal Victoria Hospital for Sick Children (Genetics Department) Belfast:&nbsp;Northern Ireland Centre for Metabolic Diseases, Belfast City Hospital (Adult)</li>
 <li>Dublin:&nbsp;National Centre for Metabolic Diseases, Children’s University Hospital</li>
 <li>Manchester:&nbsp;Willink Unit, Royal Manchester Children’s Hospital (Paediatrics) Manchester:&nbsp;The Mark Holland Metabolic Unit, Salford Royal NHS Foundation Trust (Adult)</li>
 <li>Birmingham:&nbsp;Inherited Metabolic Disorders Service, Birmingham Children’s Hospital (Paediatrics) Birmingham:&nbsp;Department of Inherited Metabolic Disorders, University Hospital Birmingham (Adult)</li>
 <li>Cambridge:&nbsp;Lysosomal Disorders Unit, Addenbrookes Hospital (Adult)</li>
 <li>Cardiff:&nbsp;Welsh Centre for Metabolic Diseases, Inherited Metabolic Diseases Service University Hospital Wales</li>
 <li>London:&nbsp;Lysosomal Storage Disease Unit, Great Ormond Street (Paediatrics) London:&nbsp;Charles Dent Metabolic Unit, The National Hospital for Neurology and Neurosurgery (Adult) London:&nbsp;Lysosomal Storage Disorders, The Royal Free Hospital (Adult)</li>
</ol>

<h2>Genetic Counselling</h2>
As a heritable disorder, genetic counselling for patients with Gaucher disease can help them plan for their future.
Patients can:
<ul>
 <li>Learn more about a health condition that runs in their family, how it’s inherited, and which family members may be affected</li>
 <li>Assess the risk of passing Gaucher disease onto their child</li>
 <li>Access information about relevant support groups</li>
</ul>

GAUCHER

RARE-DISEASE

Gaucher disease Management and Specialist Treatment Centres

Welcome to the Gaucher Disease Expert Hub page, where you can find videos and resources for your information on the diagnosis and treatment of Gaucher Disease.

Prescribing information can be found via the links at the bottom of this page.

Gaucher Talking Heads Video &ndash; Dr Mohsen Norouzi

Gaucher Talking Heads Video &ndash; Professor Tim Cox

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
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 <td>
 <a href="${link:{uuid:{3d19662e-388b-4997-9525-48f2f0b5054c},repository:{dam},path:{/Portal/UK/Prescribing-links/Cerdelga-PI-GB-November-2023--1-.pdf}}}" target="_blank">Prescribing Information GB</a> <a href="${link:{uuid:{eddd0e2c-bdbd-4b60-a4e0-8326887ad1ee},repository:{dam},path:{/Portal/UK/Prescribing-links/Cerdelga-PI-IE-NI-Aug-2023.pdf}}}" target="_blank">Prescribing Information NI</a>
 MAT-XU-2204064&nbsp;(v3.0) 
 Date of preparation: October 2023</td>
 </tr>
 </tbody>
</table>

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td>
 <a href="${link:{uuid:{e0c7ac81-08e3-479a-ba14-a4b83d650c7c},repository:{dam},path:{/Portal/UK/Prescribing-links/Cerezyme-PI-GB-May-2023.pdf}}}" target="_blank">Prescribing Information GB</a> <a href="${link:{uuid:{e4a8ed30-9b90-41fc-a882-b3dded5f22e7},repository:{dam},path:{/Portal/UK/Prescribing-links/Cerezyme-PI-IE-NI-May-2023.pdf}}}" target="_blank">Prescribing Information NI</a>
 MAT-XU-2204065&nbsp;(v3.0) 
 Date of preparation: October 2023</td>
 </tr>
 </tbody>
</table>

A selection of short videos giving greater insight into how to spot Gaucher Disease

Gaucher Disease Expert Hub

<h2>Early diagnosis is key</h2>
The early diagnosis and treatment of Gaucher disease are essential to prevent or reverse severe disease complications.1,2&nbsp;However, when Gaucher is missed, a patient can remain untreated for up to 10 years.2
If left untreated, Gaucher disease can lead to:1,2
<ul>
 <li>Premature death from bleeding complications</li>
 <li>Pulmonary hypertension</li>
 <li>Liver disease</li>
 <li>Sepsis</li>
 <li>Growth failure</li>
 <li>Complications arising from advanced bone disease</li>
 <li>Impact on quality of life</li>
</ul>

Haematologists play a pivotal role in diagnosis. In a survey of 136 Gaucher patients in the US, Australia and New Zealand:2
<ul>
 <li>86% were seen by a haematologist-oncologist in pursuit of a diagnosis in the US</li>
</ul>

In Australia and New Zealand, 73% of patients were seen by a haematologist-oncologist to obtain a diagnosis. However, a survey of over 400 haematology-oncologists in the US, Australia and New Zealand revealed that:2
<ul>
 <li>80% do not consider Gaucher disease in their differential diagnosis.</li>
</ul>

Splenomegaly and thrombocytopenia are common symptoms of Gaucher disease.3
A recent Italian study found that in patients presenting with either of these symptoms, in addition to one other specified ancillary sign of Gaucher disease, the prevalence rate of Gaucher Type 1 was found to be 3.6%.4
Simple and effective diagnostic algorithms, such as the Cappellini protocol, make it easier to identify patients with suspected Gaucher disease.1

<h3>Diagnostic algorithm for Gaucher disease type 1 in individuals of non-ashkenazi Jewish origin</h3>

Figure adapted from Mistry, P. K.,&nbsp;et al.&nbsp;2011.&nbsp;Am J Hematol&nbsp;86(1): 110–115.1
* Acid-β-glucosidase enzyme activity assay 
 ** Monoclonal gammopathy of undetermined significance

Diagnosis of Gaucher disease

<h2>Rare but not so rare</h2>
Although considered a rare disease in the general population, the prevalence of Gaucher disease is significantly higher in specific patient groups.1
Think Gaucher disease when considering the following:
<ul>
 <li>
 Patients presenting with splenomegaly and/or thrombocytopenia</li>
 <li>
 Patients with family members affected by Gaucher disease</li>
 <li>
 Patients of Ashkenazi Jewish descent</li>
</ul>
Although the disease can affect anyone of any ethnicity, there is a high prevalence of Gaucher disease in certain ethnic backgrounds. Notably those of Ashkenazi Jewish descent have a disease prevalence of approximately 1 in 800.2
Approximately 1 in every 15 people of Ashkenazi descent is a carrier of Type 1 Gaucher disease.1 Therefore it is important to test close family of patients from this background.

As an autosomal recessive disorder, a carrier of Gaucher disease has a 50% chance of having a child which carries the Gaucher gene. If both parents are carriers, there is a 25% chance that the child will be affected with Gaucher disease. If your patient has an immediate relative who has been diagnosed with Gaucher disease, it is important to order a blood test straight away.

Epidemiology of Gaucher disease

Gaucher Talking Heads Video

Gaucher Talking Heads Video - Dr Mohsen Norouzi

<h3>Speaker:</h3>
Dr Mohsen Norouzi&nbsp;–&nbsp;Consultant Haematologist, James Cook University Hospital, Middlesbrough
<h3>Learning Objectives:</h3>
Dr Mohsen Norouzi discusses diagnosing a rare metabolic disorder within a Haematology setting

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MAT-XU-2300297 (v6.0) - Date of Preparation: April 2024

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