✨ New Medicines Approval




NEW ZEALAND GAZETTE, No. 38 β€” 28 APRIL 2016

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Alacare
Aminolevulinic acid hydrochloride 10.2mg
equivalent to aminolevulinic acid 8mg
Dermal patch
Link Pharmaceuticals Limited
LTS Lohmann Therapie-Systeme AG, Andernach, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Bisolvon Dry
Dextromethorphan hydrobromide monohydrate 0.2%w/v
Oral solution
Boehringer Ingelheim (NZ) Limited
Delpharm Reims SAS, Reims, France

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:
Buscopan Forte
Hyoscine butylbromide 20mg
Film coated tablet
Boehringer Ingelheim (NZ) Limited
Delpharm Reims SAS, Reims, France

Product:
Active Ingredients:
Kombiglyze XR
Metformin hydrochloride 500mg
Saxagliptin 5mg
Dosage Form:
Modified release tablet
New Zealand Sponsor:
AstraZeneca Limited
Manufacturer:
Bristol-Myers Squibb Company, Indiana, United States of America

Product:
Active Ingredients:
Kombiglyze XR
Metformin hydrochloride 1000mg
Saxagliptin 5mg
Dosage Form:
Modified release tablet
New Zealand Sponsor:
AstraZeneca Limited
Manufacturer:
Bristol-Myers Squibb Company, Indiana, United States of America

Product:
Active Ingredients:
Kombiglyze XR
Metformin hydrochloride 1000mg
Saxagliptin 2.5mg
Dosage Form:
Modified release tablet
New Zealand Sponsor:
AstraZeneca Limited
Manufacturer:
Bristol-Myers Squibb Company, Indiana, United States of America

Product:
Active Ingredient:
Morphine Juno 10mg/1mL
Morphine hydrochloride trihydrate 10mg/mL
equivalent to morphine base 7.58mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Juno Pharmaceuticals NZ Limited
Manufacturer:
L Molteni & C Dei F lli Alitti Societa di Esercizio SpA, Firenze, Italy

Product:
Active Ingredient:
Morphine Juno 20mg/1mL
Morphine hydrochloride trihydrate 20mg/mL
equivalent to morphine base 15.18mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Juno Pharmaceuticals NZ Limited
Manufacturer:
L Molteni & C Dei F lli Alitti Societa di Esercizio SpA, Firenze, Italy

Product:
Active Ingredient:
Morphine Juno 50mg/5mL
Morphine hydrochloride trihydrate 10mg/mL
equivalent to morphine base 7.58mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
Juno Pharmaceuticals NZ Limited
Manufacturer:
L Molteni & C Dei F lli Alitti Societa di Esercizio SpA, Firenze, Italy

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2016, No 38





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
Medicines Act 1981, New Medicines, Distribution