β¨ Medicine Consent Notices
12 SEPTEMBER 2013 NEW ZEALAND GAZETTE, No. 126 3511
Product: MeniCare Plus
Active Ingredients: Baquacil 0.0005%w/v
Poloxamer 407 0.5%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Corneal Lens Corporation NZ Limited
Manufacturer: Menicon Pharma SAS, Illkirch Graffenstaden, France
Product: Progent
Solution A
Active Ingredient: Sodium hypochlorite 0.406mg/mL
Dosage Form: Contact lens solution
Solution B
Active Ingredient: Potassium bromide 0.615%w/v
Dosage Form: Contact lens solution
New Zealand Sponsor: Corneal Lens Corporation NZ Limited
Manufacturer: Menicon Pharma SAS, Illkirch Graffenstaden, France
Product: Seebri Breezhaler
Active Ingredient: Glycopyrronium bromide 0.063mg equivalent to Glycopyrronium 0.05mg
Dosage Form: Powder filled inhalation capsule
New Zealand Sponsor: Novartis New Zealand Limited
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland
Novartis Pharma Schweizerhalle AG, Schweizerhalle, Switzerland
Dated this 5th day of September 2013.
DR DON MACKIE, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
(pursuant to delegation given by the Minister of Health on 6 July 2001).
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Provisional Consent to the Distribution of New Medicines
Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:
Schedule
Product: Dianeal 1mmol/L Calcium Peritoneal Dialysis Solution 2.5%w/v
Active Ingredients:
Calcium chloride dihydrate 0.1455g/L
Glucose monohydrate 24.75g/L
Magnesium chloride hexahydrate 0.0503g/L
Sodium chloride 5.33g/L
Sodium lactate 7.4g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Old Toongabbie, Australia
Note: This consent is valid for two years from the date of publication of this notice.
Product: Dianeal 1mmol/L Calcium Peritoneal Dialysis Solution 1.5%w/v
Active Ingredients:
Calcium chloride dihydrate 0.1455g/L
Glucose monohydrate 14.85g/L
Magnesium chloride hexahydrate 0.0503g/L
Sodium chloride 5.33g/L
Sodium lactate 7.4g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Old Toongabbie, Australia
Note: This consent is valid for two years from the date of publication of this notice.
Product: Dianeal 1mmol/L Calcium Peritoneal Dialysis Solution 4.25%w/v
Active Ingredients:
Calcium chloride dihydrate 0.1455g/L
Glucose monohydrate 42.08g/L
Magnesium chloride hexahydrate 0.0503g/L
Sodium chloride 5.33g/L
Sodium lactate 7.4g/L
Dosage Form: Dialysis solution
New Zealand Sponsor: Baxter Healthcare Limited
Manufacturer: Baxter Healthcare Pty Limited, Old Toongabbie, Australia
Note: This consent is valid for two years from the date of publication of this notice.
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β¨ LLM interpretation of page content
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social Welfare5 September 2013
Medicines Act, Distribution consent, New medicines, MeniCare Plus, Progent, Seebri Breezhaler
- Dr Don Mackie, Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health
π₯ Provisional Consent to the Distribution of New Medicines
π₯ Health & Social WelfareMedicines Act, Provisional consent, New medicines, Dianeal 1mmol/L Calcium Peritoneal Dialysis Solution
- Minister of Health
NZ Gazette 2013, No 126