
Insulin Aspart (Novolog) injectable
Form: Vials/pens
Strength: U-100, U-200
Reference Brands: Novolog, Fiasp(US &EU)
Category: Diabetes
Insulin Aspart (Novolog) is a rapid-acting insulin approved in the EU and US for controlling blood glucose during meals. In the EU, Novo Nordisk’s Novolog and Fiasp are regulated by the EMA, with dossiers demonstrating safety, efficacy, and high manufacturing standards. In the US, the FDA has approved NovoLog and Fiasp based on comprehensive clinical data and biosimilarity studies, ensuring quality and consistency. Both regions require detailed regulatory dossiers and ongoing pharmacovigilance for safety monitoring. For expert assistance with regulatory dossiers and compliance, visit PharmaTradz, your trusted partner in pharmaceutical regulatory services.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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