✨ Consent to Distribution of New Medicines




NEW ZEALAND GAZETTE, No. 2
17 JANUARY 2013


Amino Acids Component:

Active Ingredients:

  • Leucine 7.4g/L
  • Lysine acetate 9.3g/L equivalent to L-Lysine 6.6g
  • Methionine 4.3g/L
  • Phenylalanine 5.1g/L
  • Proline 11.2g/L
  • Serine 6.5g/L
  • Taurine 1g/L
  • Threonine 4.4g/L
  • Tryptophan 2g/L
  • Tyrosine 0.4g/L
  • Valine 6.2g/L

Dosage Form:
Solution for infusion


Glucose component:

Active Ingredient:
Glucose monohydrate 462g/L equivalent to glucose (anhydrous) 420g/L

Dosage Form:
Solution for infusion


Lipid component:

Active Ingredients:

  • Fish oil 30g/L
  • Medium-chain triglycerides 60g/L
  • Olive oil 50g/L
  • Soya oil 60g/L

Dosage Form:
Emulsion for infusion

New Zealand Sponsor:
Fresenius Kabi New Zealand Limited

Manufacturer:
Fresenius Kabi AB, Uppsala, Sweden


Product:

Systane Balance Lubricant Eye Drops

Active Ingredient:
Propylene glycol 0.6%w/v

Dosage Form:
Eye drops, solution

New Zealand Sponsor:
Alcon New Zealand Limited

Manufacturer:
Alcon Cusi SA, Barcelona, Spain


Product:

Your Pharmacy Cetirizine Tablets

Active Ingredient:
Cetirizine hydrochloride 10mg

Dosage Form:
Tablet

New Zealand Sponsor:
Orion Laboratories (NZ) Limited

Manufacturer:
Perrigo Company, Michigan, United States of America

Dated this 9th day of January 2013.

DR STEWART JESSAMINE, Acting 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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Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new 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:
Cialis

Active Ingredient:
Tadalafil 2.5mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Eli Lilly and Company (NZ) Limited

Manufacturer:
Lilly del Caribe Inc, Carolina, Puerto Rico


Product:
Cialis

Active Ingredient:
Tadalafil 5mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Eli Lilly and Company (NZ) Limited

Manufacturer:
Lilly del Caribe Inc, Carolina, Puerto Rico


Product:
Cialis

Active Ingredient:
Tadalafil 10mg

Dosage Form:
Film coated tablet

New Zealand Sponsor:
Eli Lilly and Company (NZ) Limited

Manufacturers:

  • Lilly del Caribe Inc, Carolina, Puerto Rico
  • Lilly SA, Madrid, Spain


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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2013, No 2





✨ LLM interpretation of page content

πŸ₯ Consent to Distribution of New Medicines

πŸ₯ Health & Social Welfare
9 January 2013
Medicines, Approval, Systane Balance, Your Pharmacy Cetirizine
  • DR STEWART JESSAMINE, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
Medicines, Approval, Cialis