Ryverna 10mg/ml solution (Crizanlizumab) – Food And Drugs Authority

Ryverna 10mg/ml solution (Crizanlizumab)

Summary

Date Recall was issued:

Product Name:

Manufacturer:

Recalling Firm:

Batch(es):

Manufacturing Date:

Expiry Date:

Reason for Recall:

31^st 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.

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