Levamisole in steroid dependent and frequently relapsing nephrotic syndrome

Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Elmisol could not have been approved for the treatment of nephrotic syndrome. The Committee was concerned about some elements of the way the main study was carried out and whether these were in accordance with the requirements of good clinical practice (GCP). Other concerns included the possibility of dosing errors because the different strengths of tablet might get confused, the way the stability of the active substance in the tablets had been tested, and inadequate information on the medicine’s actions, distribution in the body and risks of interactions with other medicines.

Levamisole in steroid dependent and frequently relapsing nephrotic syndrome

levamisole in steroid dependent and frequently relapsing nephrotic syndrome

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