Ryverna 10mg/ml solution (Crizanlizumab)

Summary

Date Recall was issued:
Product Name:
Manufacturer:
Recalling Firm:
Batch(es):
Manufacturing Date:
Expiry Date:
Reason for Recall:
31st May 2024
Ryverna 10mg/ml solution (Crizanlizumab)
Novartis, Switzerland
Ernest Chemist Ltd/ Novartis
SKHL2
07/2022
30/06/2024
This recall was necessitated following the revocation of the Market Authorization for Ryverna (Crizanlizumab) from the Ghanaian market which was granted a one-year approval on 16th November 2023. This is because of the unfavourable Benefit/Risk assessment of your product from the clinical trial study “Phase III, Multipurpose, Randomized, Double-Blind Study to Assess Efficacy and Safety of Two Doses of Crizanlizumab Verses Placebo with or without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients with Vaso Occlusive Crises (STAND)”.

Announcement

This recall is necessitated as a result of warehouse market surveillance conducted at the warehouse. Actual product specification is a powder for oral suspension. The affected batches were caked and not free flowing. This makes the product substandard and therefore not recommended for its intended use.