✨ Medicines Consent Notices




7 AUGUST

NEW ZEALAND GAZETTE

2475

Note: This consent is valid for six months from the date of publication of this notice.

Dated this 5th day of August 2003.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 6th day of July 2001).

go5129

Consent to the Distribution of Changed Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the changed 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: Kabiven Peripheral

Glucose Component:

Active Ingredient: Glucose monohydrate 12.1% equivalent to 11% glucose anhydrous

Dosage Form: Solution for injection

Vamin 18 Novum Component:

Active Ingredients: Alanine 1.6%
Arginine 1.13%
Aspartic acid 0.34%
Calcium chloride dihydrate 0.074%
Glutamic acid 0.56%
Glycine 0.79%
Histidine 0.68%
Isoleucine 0.56%
Leucine 0.79%
Lysine hydrochloride 0.9%
Magnesium sulphate 0.16%
Methionine 0.56%
Phenylalanine 0.79%
Potassium chloride 0.597%
Proline 0.68%
Serine 0.45%
Sodium acetate trihydrate 0.49%
Sodium glycerophosphate 0.54%
Threonine 0.56%
Tryptophan 0.19%
Tyrosine 0.023%
Valine 0.73%

Dosage Form: Solution for injection

Intralipid Component:

Active Ingredient: Soya oil 20%

Dosage Form: Emulsion for injection

New Zealand Sponsor: Fresenius Medical Care Australia Pty Limited

Manufacturer: Fresenius Kabi AB, Uppsala, Sweden

Product: Kabiven

Glucose Component:

Active Ingredient: Glucose monohydrate 20.9% equivalent to 19% glucose anhydrous

Dosage Form: Solution for injection

Vamin 18 Novum Component:

Active Ingredients: Alanine 1.6%
Arginine 1.13%
Aspartic acid 0.34%
Calcium chloride dihydrate 0.074%
Glutamic acid 0.56%
Glycine 0.79%
Histidine 0.68%
Isoleucine 0.56%
Leucine 0.79%
Lysine hydrochloride 0.9%
Magnesium sulphate 0.16%



Next Page →



Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2003, No 94


Gazette.govt.nz PDF NZ Gazette 2003, No 94





✨ LLM interpretation of page content

πŸ₯ Provisional Consent for Diabex (continued from previous page)

πŸ₯ Health & Social Welfare
5 August 2003
Medicines Act, Provisional Consent, Diabex, Metformin hydrochloride, Pacific Pharmaceuticals, Lipha SA
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
Medicines Act, Consent, Kabiven Peripheral, Kabiven, Fresenius Medical Care, Fresenius Kabi AB