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: | Dimetapp 12 Hour Nasal Spray |
| Active Ingredient: | Oxymetazoline hydrochloride 0.5mg/mL |
| Dosage Form: | Nasal spray solution |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | PSM Healthcare Limited trading as API Consumer Brands, Auckland, New Zealand |
| Product: | Havrix 1440 vaccine |
| Active Ingredient: | Hepatitis A vaccine 1440EU/mL |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals SA, Wavre, Belgium |
| Product: | Havrix Junior |
| Active Ingredient: | Hepatitis A vaccine 1440EU/mL equivalent to 720EU/0.5mL |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA Rixensart, Belgium GlaxoSmithKline Biologicals SA, Wavre, Belgium |
| Product: | Twinrix |
| Active Ingredients: | Hepatitis A vaccine 720EU/mL Hepatitis B surface antigen, recombinant 20mcg/mL |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals SA, Wavre, Belgium |
| Product: | Twinrix Junior |
| Active Ingredients: | Hepatitis A vaccine 720EU/mL Hepatitis B surface antigen, recombinant 20mcg/mL |
| Dosage Form: | Suspension for injection |
| New Zealand Sponsor: | GlaxoSmithKline (NZ) Limited |
| Manufacturers: | GlaxoSmithKline Biologicals SA, Rixensart, Belgium GlaxoSmithKline Biologicals SA, Wavre, Belgium |
Dated this 25th day of October 2019.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).