Ozempic Important Information
Ozempic Alert: SAHPRA Grants Exemption Amid Missing Side Effect Info—What You Need to Know!
Novo Nordisk (Pty) Ltd, as directed by the South African Health Products Regulatory Authority (SAHPRA), wishes to inform you that it has obtained a section 36 exemption to distribute a designated batch of Ozempic 0.25 mg and 0.5 mg/dose pen (1.5 ml pen) registered for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. This exemption is due to the omission on our English Professional Information (PI) of the recently approved side effect of Angioedema with an unknown frequency from post-marketing reports, which falls under the MedRA system organ class “skin and subcutaneous tissue disorder”.
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