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: | Dexmedetomidine (200mcg/2mL) (Medicianz) |
| Active Ingredient: | Dexmedetomidine hydrochloride 0.118mg/mL equivalent to dexmedetomidine 0.100mg/1mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Dexmedetomidine (400mcg/4mL) (Medicianz) |
| Active Ingredient: | Dexmedetomidine hydrochloride 0.118mg/mL equivalent to dexmedetomidine 0.100mg/1mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Famar Health Care Services Madrid SAU, Madrid, Spain |
| Product: | Dexmedetomidine (1000mcg/10mL) (Medicianz) |
| Active Ingredient: | Dexmedetomidine hydrochloride 0.118mg/mL equivalent to dexmedetomidine 0.100mg/1mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Famar Health Care Services Madrid SAU, Madrid, Spain |
| Product: | Dexmedetomidine (200mcg/2mL) (Medsurge) |
| Active Ingredient: | Dexmedetomidine hydrochloride 0.118mg/mL equivalent to dexmedetomidine 0.100mg/1mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | HBM Pharma s.r.o., Martin, Slovakia |
| Product: | Dexmedetomidine (400mcg/4mL) (Medsurge) |
| Active Ingredient: | Dexmedetomidine hydrochloride 0.118mg/mL equivalent to dexmedetomidine 0.100mg/1mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Famar Health Care Services Madrid SAU, Madrid, Spain |
| Product: | Dexmedetomidine (1000mcg/10mL) (Medsurge) |
| Active Ingredient: | Dexmedetomidine hydrochloride 0.118mg/mL equivalent to dexmedetomidine 0.100mg/1mL |
| Dosage Form: | Concentrate for infusion |
| New Zealand Sponsor: | Medicianz Healthcare Limited |
| Manufacturer: | Famar Health Care Services Madrid SAU, Madrid, Spain |
| Product: | Jivi |
| Active Ingredient: | Damoctocog alfa pegol 250IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturer: | Bayer Healthcare LLC, California, United States of America |
| Product: | Jivi |
| Active Ingredient: | Damoctocog alfa pegol 500IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturer: | Bayer Healthcare LLC, California, United States of America |
| Product: | Jivi |
| Active Ingredient: | Damoctocog alfa pegol 1000IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturer: | Bayer Healthcare LLC, California, United States of America |
| Product: | Jivi |
| Active Ingredient: | Damoctocog alfa pegol 2000IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturer: | Bayer Healthcare LLC, California, United States of America |
| Product: | Jivi |
| Active Ingredient: | Damoctocog alfa pegol 3000IU |
| Dosage Form: | Powder for injection with diluent |
| New Zealand Sponsor: | Bayer New Zealand Limited |
| Manufacturer: | Bayer Healthcare LLC, California, United States of America |
| Product: | Palbociclib Pfizer |
| Active Ingredient: | Palbociclib 75mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany |
| Product: | Palbociclib Pfizer |
| Active Ingredient: | Palbociclib 100mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany |
| Product: | Palbociclib Pfizer |
| Active Ingredient: | Palbociclib 125mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Pfizer New Zealand Limited |
| Manufacturer: | Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany |
| Product: | Pirfenidone Sandoz |
| Active Ingredient: | Pirfenidone 267mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Lek Pharmaceuticals d.d., Ljubljana, Slovenia |
| Product: | Pirfenidone Sandoz |
| Active Ingredient: | Pirfenidone 801mg |
| Dosage Form: | Film coated tablet |
| New Zealand Sponsor: | Novartis New Zealand Limited |
| Manufacturer: | Lek Pharmaceuticals d.d., Ljubljana, Slovenia |
Dated this 15th day of May 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).