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: | Keytruda |
| Active Ingredient: | Pembrolizumab 25mg/mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturer: | MSD International GmbH t/a MSD Ireland, County Carlow, Ireland |
| Product: | Keytruda |
| Active Ingredient: | Pembrolizumab 50mg |
| Dosage Form: | Powder for infusion |
| New Zealand Sponsor: | Merck Sharp & Dohme (New Zealand) Limited |
| Manufacturer: | MSD International GmbH, Country Cork, Ireland |
| Product: | Klacid |
| Active Ingredient: | Clarithromycin 25mg/mL |
| Dosage Form: | Granules for oral suspension |
| New Zealand Sponsor: | Mylan New Zealand Ltd |
| Manufacturers: | Aesica Queenborough Limited, Kent, United Kingdom AbbVie S.r.l, Latina, Italy |
| Product: | Klacid |
| Active Ingredient: | Clarithromycin 250mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Mylan New Zealand Ltd |
| Manufacturers: | Aesica Queenborough Limited, Kent, United Kingdom AbbVie S.r.l, Latina, Italy |
| Product: | Klacid |
| Active Ingredient: | Clarithromycin 50mg/mL |
| Dosage Form: | Granules for oral suspension |
| New Zealand Sponsor: | Mylan New Zealand Ltd |
| Manufacturer: | AbbVie S.r.l, Latina, Italy |
| Product: | Klacid |
| Active Ingredient: | Clarithromycin 500mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Mylan New Zealand Ltd |
| Manufacturers: | Aesica Queenborough Limited, Kent, United Kingdom AbbVie S.r.l, Latina, Italy |
| Product: | Klacid IV |
| Active Ingredient: | Clarithromycin 500mg |
| Dosage Form: | Powder for injection |
| New Zealand Sponsor: | Mylan New Zealand Ltd |
| Manufacturer: | Delpharm Saint Rémy, Saint Rémy Sur Avre, France |
| Product: | Topicaine |
| Active Ingredients: | Adrenaline acid tartrate 0.18%w/v Lidocaine hydrochloride monohydrate 4%w/v Tetracaine hydrochloride 0.5%w/v |
| Dosage Form: | Topical solution |
| New Zealand Sponsor: | Biomed Limited |
| Manufacturer: | Biomed Limited, Auckland, New Zealand |
Dated this 10th day of November 2020.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).