
Ustekinumab Injection
Form: SQ and IV injection
Strength: SQ:: 45 mg, 90 mg; IV: 130 mg/vial
Reference Brands: Stelara(US)
Category: Immune Disorder
Ustekinumab injection, marketed as Stelara, is approved in the US by the FDA and in the EU via EMA for Crohn’s disease, psoriatic arthritis, and psoriasis. Regulatory approval requires comprehensive dossiers including clinical trial data, manufacturing details, safety, efficacy, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical and quality data, while the EMA ensures compliance with regional standards. For guidance on dossier preparation, regulatory pathways, and market entry strategies, visit PharmaTradz. Ensuring thorough regional compliance is essential for the safe, effective, and timely approval of ustekinumab injectable products worldwide, supporting optimal patient outcomes in autoimmune disease management.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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