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Omnitrope Pen 5

Sandoz GmbH · Model 49036229 · UDI-DI 59002269207349

NSC Prescription

510(k) clearances

671

Adverse events (1 deaths)

Recalls

Facilities

Description

The Omnitrope Pen 5 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It is intended for patients (pediatric patients and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a trained caregiver in case of small children or patients unable to perform the injection themselves. For information on the use of Omnitrope Pen 5, see: http://www.omnitrope.com/getting-started/injection-training/

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.