Regulatory Decision Summary for Galli Eo

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Medicinal ingredient(s):

Gallium (68 Ga) Chloride generator

Therapeutic area:

Diagnostic radiopharmaceutical

Type of submission:

New Drug Submission (NDS)

Control number:

221824
What was the purpose of this submission?

 

This New drug Submission (NDS) was filed to obtain market authorization for the Galli Eo generator, used to extract the positron-emitting isotope, gallium-68 (68Ga) from the parent isotope, germanium-68 (68Ge). The eluate, Gallium (68 Ga) Chloride Solution, is indicated for in vitro radiolabelling of radiopharmaceutical ligands for diagnostic procedures using positron emission tomography (PET).

 

Why was the decision issued?

 

The market authorization was based on review of the chemistry and manufacturing data for the Galli Eo generator. Quality data was provided for 6 batches of generators ranging from 0.74 to 1.85GBq demonstrating that the IRE ELiT process is capable of producing generators that meet established specifications. A shelf-life of 53 weeks at room temperature was approved.

Upon elution, the eluate recovered from this generator fully complies with the specifications of the European Pharmacopoeia Monograph # 2464 "Gallium (68Ga) chloride solution for radiolabelling.

The Galli Eo generator has no clinical indication and its eluate, Gallium (68Ga) Chloride solution, is not administered directly to patients. The eluate (gallium (68Ga) chloride solution) is used exclusively for in vitro radiolabelling of specific carrier molecules, which have been developed and authorised for radiolabelling with this radionuclide to be used for diagnostic imaging with positron emission tomography (PET).

For more information on Health Canadas decision, please view the Summary Basis of Decision.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.