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)

FDA Label Image

Figure 2 (Figure2)

This text provides a breakdown of performance standard scores with associated age information for natural history and LENMELDY categories related to cognitive impairment levels. It indicates the standard scores, age range, and severity levels such as mild, moderate, and severe cognitive impairment.*

FDA Label Image

Figure 3 (Figure3)

This is a table showing language standard scores across different age groups, with categories for mild, moderate, and severe cognitive impairment. The table also includes natural history and imputed values for evaluation.*

FDA Label Image

Infusion Bag (Infusion Bag)

This text is not readable.*

FDA Label Image

Overwrap Bag (Overwrap Bag)

This text provides information about a product containing genetically modified autologous hematopoietic stem cells for autologous use only. It is intended for intravenous use and comes in single-dose bags stored in liquid nitrogen. Specific storage and administration instructions are provided, and precautions against re-freezing are outlined. The product is not evaluated for infectious substances and does not contain preservatives. Additional details include the manufacturing information, dosage details, and patient identifier fields for administration.*

FDA Label Image

Tert Cass (Tert Cass)

This text provides information about a medical product containing genetically modified autologous hematopoietic stem cells intended for autologous use through intravenous administration. The product is stored in a cryopreservation solution with specifications for storage and usage. It emphasizes not using leukodepletion filters or irradiation. Additionally, it includes details on patient identifiers and manufacturing information. For complete dosing and administration guidelines, the prescribing information should be consulted.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.