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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS11.NAME OF THE MEDICINAL PRODUCTOpsumit 10 mg film coated tablets2.QUALITATIVE AND QUANTITATIVE Compositional film coated tablet contains 10 mg macitentan. Recipients
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To fill out an INN-Macitentan EPAR, follow these steps:
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Start by writing the full name of the patient at the top of the form.
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Fill in the patient's date of birth, gender, and contact information.
04
Provide the patient's medical history, including any previous treatments they have received.
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Indicate the reason for prescribing INN-Macitentan and the dosage instructions.
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Attach any relevant medical reports or test results that support the need for this medication.
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Complete the form with the prescribing doctor's information and signature.
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Check that all the information provided is accurate and legible.
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Submit the filled-out INN-Macitentan EPAR to the appropriate health authority or institution.

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INN-Macitentan EPAR is typically prescribed for patients with certain medical conditions that require treatment with this medication.
02
It is commonly used for individuals diagnosed with pulmonary arterial hypertension (PAH), a chronic and progressive condition that affects the arteries in the lungs.
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Patients who experience symptoms such as shortness of breath, fatigue, chest pain, and fainting associated with PAH may benefit from INN-Macitentan treatment.
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Ultimately, it is the healthcare provider who determines if a patient needs INN-Macitentan EPAR based on their medical evaluation and assessment of the individual's condition.
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INN-Macitentan EPAR refers to the European Public Assessment Report for the medicinal product Macitentan, which is used to treat pulmonary arterial hypertension.
The marketing authorization holders or sponsors of the medicinal product Macitentan are required to file the INN-Macitentan EPAR.
To fill out the INN-Macitentan EPAR, the sponsor must provide information regarding the medicine's clinical data, manufacturing details, safety, and efficacy, following the guidelines provided by the European Medicines Agency.
The purpose of the INN-Macitentan EPAR is to provide a comprehensive assessment of the efficacy and safety of Macitentan, ensuring that it meets the required standards for marketing authorization in the EU.
The INN-Macitentan EPAR must report information regarding the product's pharmacological properties, clinical trials results, adverse effects, and any relevant risk management plans.
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