Tegretol Oral Suspension, limitation of use in neonates
During an ongoing procedure in another country for label update for Tegretol® 100 mg/5ml Oral Suspension, the process triggered an assessment of the amount of propylene glycol in the product. Propylene Glycol, an excipient used in this product formulation, was found to be above the threshold of (1 mg/kg/day) for neonates (refer to respective EMA […]
Hydrochlorothiazide – Risk Of Non Melanoma Skin Cancer ( Basal Cell Carcinoma, Squamous Cell Carcinoma)
In agreement with Botswana Medicines Regulatory Authority,(BOMRA) Sanofi would like to inform you of the following about HCTZ-containing products: