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pp-037

Injection, pre-filled pen

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
Comments
Indication: Primary: Acromegaly (patients controlled on somatostatin receptor ligands), submitted for registration . Additional: Gastroenteropancreatic neuroendocrine tumors (GEP-NET)- Phase III, Polycystic Liver Disease (PLD) in development- Phase II. A long-acting, subcutaneous depot formulation of the somatostatin analogue Octreotide, developed using proprietary patented technology for sustained release and improved bioavailability. Designed for once-monthly self-administration with a pre-filled autoinjector pen, enhancing convenience versus intramuscular or more frequent injection regimens. Differentiation: Better bioavailability and no lag phase after injection; supports improved patient convenience and self-administration.
Manufacturer #38501

This Swedish biopharmaceutical organization develops and commercializes long-acting treatments for severe and chronic diseases. It specializes in advanced drug-delivery systems designed to improve therapeutic outcomes and patient adherence. Its portfolio includes marketed products and a research pipeline targeting areas such as opioid dependence, endocrine disorders, and oncology.

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