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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS11.NAME OF THE MEDICINAL PRODUCTRemicade 100 mg powder for concentrate for solution for infusion. 2.QUALITATIVE AND QUANTITATIVE Compositional vial of contains
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How to fill out inn- - european medicines
How to fill out inn- - european medicines
01
To fill out INN (International Nonproprietary Name) for European Medicines, you need to follow these steps:
02
Begin by writing the full name of the medicine.
03
Include the brand name of the medicine if it is available.
04
Write the generic name of the medicine, which is commonly denoted by the acronym INN.
05
Specify the dosage form of the medicine, such as tablet, capsule, injection, etc.
06
Indicate the strength or concentration of the medicine.
07
Provide any additional instructions or relevant information.
08
Double-check the accuracy of the information provided.
09
Submit the filled-out INN form for European Medicines.
Who needs inn- - european medicines?
01
INN for European Medicines is needed by pharmaceutical companies, regulatory authorities, healthcare professionals, and other stakeholders involved in the development, licensing, manufacturing, prescribing, and dispensing of medicines in the European market.
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What is inn- - european medicines?
INN (International Nonproprietary Name) refers to a unique name that is globally recognized and used to identify a pharmaceutical substance or active ingredient, independent of the manufacturer.
Who is required to file inn- - european medicines?
Manufacturers and developers of pharmaceutical products are required to file for INN when they intend to market a new medicinal product within European markets.
How to fill out inn- - european medicines?
Filing for an INN generally involves submitting an application to the designated authority, providing necessary details about the substance, including its chemical composition, pharmacological properties, and proposed labeling.
What is the purpose of inn- - european medicines?
The purpose of the INN system is to provide a standard nomenclature to avoid confusion in drug naming, facilitate communication and promote patient safety by ensuring that each pharmaceutical ingredient is uniquely identifiable.
What information must be reported on inn- - european medicines?
The information required typically includes the proposed name, chemical structure, pharmacological classification, intended therapeutic use, and data on the substance's safety and efficacy.
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