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 set out in the Schedule hereto:
Schedule
| Product: | Erlotinib (Teva) |
| Active Ingredient: | Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | S.C. Sindan-Pharma S.R.L., Bucharest, Romania |
| Product: | Erlotinib (Teva) |
| Active Ingredient: | Erlotinib hydrochloride 109.28mg equivalent to erlotinib 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | S.C. Sindan-Pharma S.R.L., Bucharest, Romania |
| Product: | Erlotinib (Teva) |
| Active Ingredient: | Erlotinib hydrochloride 163.93mg equivalent to erlotinib 150mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
| Manufacturer: | S.C. Sindan-Pharma S.R.L., Bucharest, Romania |
| Product: | Jorveza |
| Active Ingredient: | Budesonide 0.5mg |
| Dosage Form: | Orodispersible tablet |
| New Zealand Sponsor: | Dr Falk Pharma New Zealand Limited |
| Manufacturer: | Losan Pharma GmbH, Neuenburg, Germany |
| Product: | Jorveza |
| Active Ingredient: | Budesonide 1mg |
| Dosage Form: | Orodispersible tablet |
| New Zealand Sponsor: | Dr Falk Pharma New Zealand Limited |
| Manufacturer: | Losan Pharma GmbH, Neuenburg, Germany |
| Product: | Travel Ease |
| Active Ingredient: | Meclozine hydrochloride 25mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Pharmabroker Sales Limited |
| Manufacturer: | Delpharm Evreux SAS, Evreux, France |
Dated this 20th day of June 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).