Darleukin
Form: Intralesional injection
Strength: A standardized dose of 120 million adipose-derived stem cells per injection
Reference Brands: Alofisel(US & EU)
Category: Cell & Gene Therapies
Darleukin (alozifil) is regulated in the EU and US, supported by dossiers demonstrating safety, efficacy, and manufacturing quality in compliance with GMP standards. In the US, FDA approval involved extensive clinical trial data and safety assessments. In the EU, CE marking certifies conformity with MDR standards for treatment of Crohn’s disease-related perianal fistulas. These gene therapies undergo validation, stability testing, and thorough audits, with comprehensive documentation including safety profiles, clinical trial results, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to advanced biologic therapies supporting complex Crohn’s disease management globally.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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