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: | Bromhexine Chesty Tablets |
| Active Ingredient: | Bromhexine hydrochloride 8mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Medreich Limited, Bangalore, India |
| Product: | Medreich Bromhexine Chesty Tablets |
| Active Ingredient: | Bromhexine hydrochloride 8mg |
| Dosage Form: | Tablet |
| New Zealand Sponsor: | Medreich New Zealand Limited |
| Manufacturer: | Medreich Limited, Bangalore, India |
| Product: | Suboxone Film |
| Active Ingredients: | Buprenorphine hydrochloride 2.16mg equivalent to buprenorphine 2mg Naloxone hydrochloride dihydrate 0.61mg equivalent to naloxone 0.5mg |
| Dosage Form: | Wafer |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Aquestive Therapeutics, Indiana, United States of America |
| Product: | Suboxone Film |
| Active Ingredients: | Buprenorphine hydrochloride 4.32mg equivalent to buprenorphine 4mg Naloxone hydrochloride dihydrate 1.22mg equivalent to naloxone 1mg |
| Dosage Form: | Wafer |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Aquestive Therapeutics, Indiana, United States of America |
| Product: | Suboxone Film |
| Active Ingredients: | Buprenorphine hydrochloride 8.64mg equivalent to buprenorphine 8mg Naloxone hydrochloride dihydrate 2.44mg equivalent to naloxone 2mg |
| Dosage Form: | Wafer |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Aquestive Therapeutics, Indiana, United States of America |
| Product: | Suboxone Film |
| Active Ingredients: | Buprenorphine hydrochloride 12.96mg equivalent to buprenorphine 12mg Naloxone hydrochloride dihydrate 3.66mg equivalent to naloxone 3mg |
| Dosage Form: | Wafer |
| New Zealand Sponsor: | Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics |
| Manufacturer: | Aquestive Therapeutics, Indiana, United States of America |
Dated this 15th day of October 2021.
DEREK FITZGERALD, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).