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: | Fexaclear |
| Active Ingredient: | Fexofenadine hydrochloride 120mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Medreich Limited, Bangalore, India |
| Product: | Fexaclear |
| Active Ingredient: | Fexofenadine hydrochloride 180mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Medreich Limited, Bangalore, India |
| Product: | Gabapentin |
| Active Ingredient: | Gabapentin 100mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Max Health Limited |
| Manufacturer: | Rivopharm SA, Manno, Switzerland |
| Product: | Gabapentin |
| Active Ingredient: | Gabapentin 300mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Max Health Limited |
| Manufacturer: | Rivopharm SA, Manno, Switzerland |
| Product: | Gabapentin |
| Active Ingredient: | Gabapentin 400mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Max Health Limited |
| Manufacturer: | Rivopharm SA, Manno, Switzerland |
| Product: | Paracetamol Soft Gel Caps (General sale) |
| Active Ingredient: | Paracetamol 500mg |
| Dosage Form: | Soft gelatin capsule |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | XL Laboratories Pvt. Limited, Neemrana, India |
| Product: | Paracetamol Soft Gel Caps (Pharmacy only) |
| Active Ingredient: | Paracetamol 500mg |
| Dosage Form: | Soft gelatin capsule |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | XL Laboratories Pvt. Limited, Neemrana, India |
| Product: | Sitagliptin Sandoz |
| Active Ingredient: | Sitagliptin hydrochloride monohydrate 28.343mg equivalent to sitagliptin 25mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturer: | Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia |
| Product: | Sitagliptin Sandoz |
| Active Ingredient: | Sitagliptin hydrochloride monohydrate 56.685mg equivalent to sitagliptin 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturer: | Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia |
| Product: | Sitagliptin Sandoz |
| Active Ingredient: | Sitagliptin hydrochloride monohydrate 113.37mg equivalent to sitagliptin 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Sandoz New Zealand Limited |
| Manufacturer: | Novartis Pharmaceutical Manufacturing LLC, Ljubljana, Slovenia |
Dated this 7th day of June 2024.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).