General Information
Product name
CVD 103-HgR
Manufacturer Name
Paxvax Berna GmbH
Icons in SDS
Company Information
company name
Paxvax Berna GmbH
Section 2
2.1 Classification of the substance or mixture
Not classified. Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device.
2.2 Label elements
Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device. Hazard(s) not otherwise classified (HNOC): CVD 103-HgR is the active ingredient in the oral vaccine marketed as Vaxchora™ (Cholera Vaccine, Live, Oral), indicated for active immunization against disease caused by V. cholerae serogroup O1. In clinical trials, the most common adverse events (incidence>3%) following oral administration of the vaccine were tiredness (31%), headache (29%), abdominal pain (19%), nausea/vomiting (18%), lack of appetite (17%) and diarrhea (4%). An extensive environmental risk assessment of the strain CVD 103-HgR was performed. The study concluded that the strain posed no risk to the environment. The host range of Vibrio cholerae is exclusively restricted to human beings.
