Lenmeldy Suspension
Product Images NDC 83222-0200

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Lenmeldy (NDC 83222-0200). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Orchard Therapeutics (europe) Ltd, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure 1 (Figure1)

A Kaplan-Meier survival curve comparing percent estimates of severe motor impairment-free survival over chronological age in years. The graph shows two lines: one representing LENMELDY treatment and another representing natural history, with censored data points marked by circles. Numbers at risk for each group are listed below the x-axis.*

FDA Label Image

Figure 2 (Figure2)

A line chart depicting the Performance Standard Score plotted against Age (Years). It compares Natural History Standard Scores and LENMELDY Standard Scores, including their imputed values. The chart also indicates thresholds for mild, moderate, and severe cognitive impairment with dashed lines at different score levels.*

FDA Label Image

Figure 3 (Figure3)

A line graph comparing Language Standard Scores by Age (years) for patients under Natural History and LENMELDY treatment. Data points for Natural History are marked by filled and open triangles, while LENMELDY scores use filled and open circles. The graph includes horizontal lines indicating thresholds for mild, moderate, and severe cognitive impairment levels.*

FDA Label Image

Infusion Bag (Infusion Bag)

LENMELDY atidarsagene autotemcel cellular therapy suspension for intravenous infusion. The label indicates a volume of 10 to 20 mL containing 1.8 to 11.8 x 10^6 CD34+ cells per mL, intended for autologous use only and single-dose. Manufactured by AGC Biologics, Italy, and labeled by Orchard Therapeutics, Boston, MA. Patient identifier fields are included on the label.*

FDA Label Image

Overwrap Bag (Overwrap Bag)

Label for LENMELDY atidarsagene autotemcel suspension for intravenous infusion, containing 1.8 to 11.8 million CD34+ cells per mL in 10 to 20 mL volume. It is a single-dose autologous cellular therapy. The label includes storage instructions below -130°C, warnings against leukodepleting filters or irradiation, and details for patient identifier confirmation. Manufactured by AGC Biologics S.p.A, Italy, for Orchard Therapeutics (Europe) Ltd.*

FDA Label Image

Tert Cass (Tert Cass)

Label for LENMELDY (atidarsagene autotemcel) suspension for intravenous infusion by Orchard Therapeutics (Europe) Ltd. It contains genetically modified autologous hematopoietic stem cells in cryopreservation solution with 5% DMSO, stored under liquid nitrogen vapor phase. The label includes dosing information, patient identifiers fields, and manufacturer details from AGC Biologics in Italy and Orchard Therapeutics in Boston, MA.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.