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Get the free Summary of Product Characteristics - Medicines Authority - serb ohio

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03202018 139604 17MED050720 K36685TABLE OF CONTENTS Page Prea1nble/Purpose ...........................................................................................................................
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To fill out the summary of product characteristics, follow these steps:
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Start by providing relevant information about the product, such as its name, active ingredients, and dosage form.
03
Include a brief description of the product's therapeutic indications, listing the conditions it is intended to treat.
04
Specify the posology and method of administration, detailing the recommended dosage and frequency of use.
05
Mention any special warnings or precautions that should be observed when using the product, such as potential side effects or contraindications.
06
Provide information on the product's pharmaceutical form and shelf-life, including storage conditions.
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Include details about the product's composition, including the quantity of active substances and any excipients used.
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Finally, add information about the marketing authorization holder and the date of the last revision of the summary of product characteristics.

Who needs summary of product characteristics?

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The summary of product characteristics is primarily needed by healthcare professionals and regulatory authorities.
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Healthcare professionals, such as doctors and pharmacists, rely on the summary of product characteristics to understand important information about a product, including its indications, dosage, and potential risks.
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Regulatory authorities use the summary of product characteristics to evaluate the safety and efficacy of a product before granting marketing authorization.
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In addition to healthcare professionals and regulatory authorities, patients may also benefit from accessing the summary of product characteristics to educate themselves about the product they are using or considering to use.
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Summary of Product Characteristics (SPC) is a document that provides information on a medicinal product and its intended use.
Marketing authorization holders are required to file summary of product characteristics for their medicinal products.
Summary of Product Characteristics can be filled out by providing detailed information on the medicinal product, its composition, indications, dosage, contraindications, adverse effects, and other relevant information.
The purpose of summary of product characteristics is to provide healthcare professionals and patients with essential information about the safe and effective use of a medicinal product.
Information such as composition, indications, dosage, contraindications, adverse effects, precautions, interactions, and pharmacological properties must be reported on summary of product characteristics.
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