Gazette.govt.nzPursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:
Schedule
| Product: | Avren 200 |
| Active Ingredient: | Misoprostol 200mcg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | REX Medical Limited |
| Manufacturer: | Cipla Limited, Salcette, India |
| Product: | Dukoral |
| Active Ingredients: | Recombinant cholera toxin B subunit 1mg Vibrio cholerae Inaba 48 Classical biotype 31250 million organisms Vibrio cholerae Inaba 6973 El Tor biotype 31250 million organisms Vibrio cholerae Ogawa 50 Classical biotype 62500 million organisms |
| Dosage Form: | Oral suspension |
| New Zealand Sponsor: | Seqirus (NZ) Limited |
| Manufacturers: | Valneva Sweden AB, Solna, Sweden Recipharm Stockholm AB, Arsta, Sweden Recipharm Hoganas AB, Hoganas, Sweden |
| Product: | Hexaxim |
| Active Ingredients: | Diphtheria toxoid, adsorbed 30Lf U equivalent to not less than 20IU Haemophilus influenzae type b polysaccharide 12mcg Hepatitis B virus surface antigen 10mcg Pertussis filamentous haemagglutinin 25mcg Pertussis toxoid, adsorbed 25mcg Polio virus type 1 40DAgU Polio virus type 2 8DAgU Polio virus type 3 32DAgU Tetanus toxoid, adsorbed 10Lf U equivalent to not less than 40IU |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | Sanofi-Aventis New Zealand Limited |
| Manufacturers: | Sanofi Pasteur SA, Marcy L’Etoile, France Sanofi Pasteur SA, Val-De-Reuil Cedex, France |
| Product: | Probenecid-AFT |
| Active Ingredient: | Probenecid 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Sigma Laboratories Private Limited, Mapusa, India |
| Product: | Rotarix Oral Vaccine |
| Active Ingredient: | Live attenuated human rotavirus 1000000CCID50 |
| Dosage Form: | Oral suspension |
| New Zealand Sponsor: | GlaxoSmithKline NZ Limited |
| Manufacturer: | GlaxoSmithKline Biologicals SA, Wavre, Belgium |
Dated this 6th day of December 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).