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: | Azithromycin-AFT |
| Active Ingredient: | Azithromycin dihydrate 524.1mg equivalent to azithromycin 500mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Hainan Poly Pharma Co. Limited, Haikou, China |
| Product: | Beovu (27.6mg/0.23mL) |
| Active Ingredient: | Brolucizumab 120mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Novartis Pharma Stein AG, Stein, Switzerland |
| Product: | Beovu (Pre-filled syringe 19.8mg/0.165mL) |
| Active Ingredient: | Brolucizumab 120mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Alcon Couvreur NV, Puurs, Belgium |
| Product: | Bepanthen Care |
| Active Ingredient: | Dexpanthenol 50mg/g |
| Dosage Form: | Topical ointment |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturer: | GP Grenzach Produktions GmbH, Grenzach-Wyhlen, Germany |
| Product: | Codral Cold & Flu + Mucus Cough |
| Active Ingredients: | Guaifenesin 100mg Paracetamol 500mg Phenylephrine hydrochloride 6.1mg equivalent to phenylephrine 5mg |
| Dosage Form: | Capsule |
| New Zealand Sponsor: | Johnson & Johnson (New Zealand) Limited |
| Manufacturer: | Wrafton Laboratories Limited, Braunton, United Kingdom |
| Product: | Darzalex SC |
| Active Ingredient: | Daratumumab 120mg/mL |
| Dosage Form: | Solution for injection |
| New Zealand Sponsor: | Janssen-Cilag (New Zealand) Limited |
| Manufacturer: | Cilag AG, Schaffhausen, Switzerland |
| Product: | Galvumet |
| Active Ingredients: | Metformin hydrochloride 500mg Vildagliptin 50mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturers: | Novartis Pharma Produktions GmbH, Wehr, Germany Novartis Pharma Stein AG, Stein, Switzerland Novartis Singapore Pharmaceutical Manufacturing Pte Limited, Singapore City, Singapore |
| Product: | Ibrance |
| Active Ingredient: | Palbociclib 75mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany |
| Product: | Ibrance |
| Active Ingredient: | Palbociclib 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany |
| Product: | Ibrance |
| Active Ingredient: | Palbociclib 125mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany |
| Product: | Opti-Soothe |
| Active Ingredient: | Chloramphenicol 5mg/mL |
| Dosage Form: | Eye drops, solution |
| New Zealand Sponsor: | AFT Pharmaceuticals Limited |
| Manufacturer: | Excelvision, Annonay, France |
Dated this 10th day of May 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).