Romiplostim injection
Form: Injection
Strength: 250mcg/vial, 500 mcg/vial
Reference Brands: Nplate®(US & EU)
Category: Orphan Drugs
Romiplostim injection, marketed as Nplate®, is approved by the FDA and EMA for treating chronic immune thrombocytopenic purpura (ITP). Regulatory dossiers include comprehensive clinical trial data, manufacturing standards, and safety profiles, ensuring high-quality product approval. The dossiers support its efficacy in increasing platelet counts and reducing bleeding risk. Nplate® is administered as a subcutaneous injection, with dosing tailored to patient needs. For detailed information on regulatory processes, dossier submissions, and market approvals in the EU and US, visit PharmaTradz, your trusted source for pharmaceutical regulatory insights and industry updates.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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