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: | Actair 100 IR & 300 IR Initiation treatment sublingual tablets |
| Component 1: | |
| Active Ingredients: | Dermatophagoides farinae allergen extract 50IR Dermatophagoides pteronyssinus allergen extract 50IR |
| Dosage Form: | Sublingual tablet |
| Component 2: | |
| Active Ingredients: | Dermatophagoides farinae allergen extract 150IR Dermatophagoides pteronyssinus allergen extract 150IR |
| Dosage Form: | Sublingual tablet |
| New Zealand Sponsor: | Stallergenes Greer New Zealand Limited |
| Manufacturer: | Cenexi SAS, Osny, France |
| Product: | Actair 300 IR Continuation treatment sublingual tablets |
| Active Ingredients: | Dermatophagoides farinae allergen extract 150IR Dermatophagoides pteronyssinus allergen extract 150IR |
| Dosage Form: | Sublingual tablet |
| New Zealand Sponsor: | Stallergenes Greer New Zealand Limited |
| Manufacturer: | Cenexi SAS, Osny, France |
| 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: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Sanofi Pasteur SA, Val-De-Reuil Cedex, France |
| Product: | Merieux Inactivated Rabies Vaccine (MIRV) |
| Active Ingredient: | Rabies vaccine, Wistar PM/WI 38-1503-3M 2.5IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturers: | Sanofi Pasteur SA, Marcy L’Etoile, France Sanofi Pasteur SA, Val-De-Reuil Cedex, France |
| Product: | Nimenrix |
| Active Ingredients: | Neisseria meningitidis Group A polysaccharide, tetanus toxoid conjugate 5mcg Neisseria meningitidis Group C polysaccharide, tetanus toxoid conjugate 5mcg Neisseria meningitidis Group W135 polysaccharide, tetanus toxoid conjugate 5mcg Neisseria meningitidis Group Y polysaccharide, tetanus toxoid conjugate 5mcg |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA, Wavre, Belgium Pfizer Manufacturing Belgium NV, Puurs-Sint-Amands, Belgium |
Dated this 3rd day of April 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).