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High strength, fixed combination and biosimilar
insulin products: minimizing the risk of medication
error
From:
Medicines and Healthcare Products Regulatory Agency
Published:
29 April 2015
Therapeutic
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What is high strength fixed combination?
High strength fixed combination refers to a medication that contains multiple active ingredients in high concentrations.
Who is required to file high strength fixed combination?
Manufacturers or distributors of high strength fixed combination medications are required to file.
How to fill out high strength fixed combination?
The filing process for high strength fixed combination typically involves providing detailed information about the medication's active ingredients, formulation, and intended use.
What is the purpose of high strength fixed combination?
The purpose of high strength fixed combination is to provide a more effective treatment option by combining multiple active ingredients in high concentrations.
What information must be reported on high strength fixed combination?
Information such as the composition of active ingredients, dosage form, strength, packaging, and labeling must be reported on high strength fixed combination.
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