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MODULE 1 ADMINISTRATIVE PARTICULARS OF THE PRODUCT 1.1 Product Information 1.1.1 Summary of Product Characteristics (DMPC)1.3.1.1. Name of the medicinal product: 1.3.1.1.1 (Invented) name of the medicinal
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01
Obtain the latest version of the Summary of Product Characteristics (SPC) template specific to European regulations.
02
Fill in the basic information about the product, including its name, pharmaceutical form, strength, and packaging.
03
Provide detailed information about the composition of the product, including active substances, excipients, and any other relevant components.
04
Include information on the therapeutic indications, posology, method of administration, contraindications, special warnings and precautions for use, interactions, adverse reactions, and pharmacodynamic properties.
05
Add details on the pharmaceutical properties of the product, such as shelf life, special precautions for storage, and any other relevant information.
06
Include information on the marketing authorization holder, the date of the latest renewal of the marketing authorization, and the date of revision of the SPC.

Who needs summary of product characteristicseuropean?

01
Pharmaceutical companies seeking marketing approval for their products in Europe.
02
Healthcare professionals and pharmacists who need comprehensive and up-to-date information on pharmaceutical products.
03
Regulatory authorities responsible for assessing the safety, efficacy, and quality of medicinal products.
04
Researchers and academics studying pharmaceutical products and their characteristics.
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Summary of Product Characteristics (SPC) is a document that provides information on a pharmaceutical product, including its composition, indications, dosage, side effects, and more.
Marketing authorization holders are required to file Summary of Product Characteristics (SPC) for their pharmaceutical products.
Summary of Product Characteristics (SPC) can be filled out by compiling information on the pharmaceutical product as per the regulatory requirements set by the European Medicines Agency (EMA).
The purpose of Summary of Product Characteristics (SPC) is to provide healthcare professionals and patients with essential information about a pharmaceutical product to ensure its safe and effective use.
Summary of Product Characteristics (SPC) must include information on the composition, indications, dosage, contraindications, side effects, precautions, and more.
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