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Zeaxanthin is another necessary carotenoid that works alongside lutein to protect the eyes from oxidative harm and harmful blue gentle.<br><br>Because of this the developer will obtain scientific and regulatory support from EMA to advance their medication to the stage the place they will apply for a marketing authorisation. Orphan designation doesn't mean the medicine is obtainable or authorised for use. All medicines, together with designated orphan medicines, should be authorised earlier than they are often marketed and made available to patients in the EU. During the medication's growth, medical doctors may be able to enrol patients in clinical trials investigating the medicine. Patients with glycogen storage disease type Ia lack an enzyme known as glucose-6-phosphatase-? The medication contains a molecule referred to as messenger RNA (mRNA) which has instructions for making the enzyme. The mRNA is contained in tiny particles of fats (lipids) that stop it from being broken down too quickly. When a affected person is given the drugs, some of their cells will read the mRNA instructions and temporarily produce the enzyme. This is predicted to normalise the storage and management of sugars in the physique and scale back the symptoms of the situation. The mRNA from the medication doesn't stay within the body but is broken down shortly after the medicine is given. The results of the medicine had been evaluated in experimental fashions. No clinical trials with the drugs in patients with glycogen storage disease type Ia had been started. More information on how potential new medicines are tested throughout their development is accessible on Authorisation of medicines. Medicines intended for uncommon diseases will be granted an orphan designation throughout their improvement. EMA's Committee for Orphan Medicinal Products (COMP) is chargeable for issuing opinions on purposes for orphan designations. The Agency sends the COMP opinion to the European Commission, which is responsible for granting the orphan designation. The total checklist of orphan designations is accessible in the community register of orphan medicinal merchandise for human use.<br>
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Version actuelle datée du 7 décembre 2025 à 14:08


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