✨ Medicines Consent Notices




NEW ZEALAND GAZETTE

No. 154

3950

Product:
Lemsip Max Day & Night

Daytime component:
Active Ingredients:
Dextromethorphan hydrobromide 10mg
Paracetamol 300mg
Pseudoephedrine hydrochloride 30mg

Dosage Form:
Liquid filled capsule

Night-time component:
Active Ingredients:
Chlorpheniramine maleate 2mg
Paracetamol 300mg
Pseudoephedrine hydrochloride 30mg

Dosage Form:
Liquid filled capsule

New Zealand Sponsor:
Reckitt Benckiser (New Zealand) Limited

Manufacturer:
R P Scherer Holdings Pty Limited, Braeside, Victoria, Australia

Product:
X-Opaque HD

Active Ingredient:
Barium sulphate 966mg/g

Dosage Form:
Oral suspension

New Zealand Sponsor:
Siemens (NZ) Limited

Manufacturer:
Hellay Laboratories Pty Limited, Dandenong, Victoria, Australia

Dated this 9th day of October 2002.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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Renewal of Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product:
Serecid

Active Ingredient:
Hydroxyzine hydrochloride 10mg

Dosage Form:
Capsule

New Zealand Sponsor:
Douglas Pharmaceuticals Limited

Manufacturer:
Banner Pharmacaps (Canada) Limited, Olds, Alberta, Canada

Note: This consent is valid for two years from 26 November 2002.

Product:
Serecid

Active Ingredient:
Hydroxyzine hydrochloride 25mg

Dosage Form:
Capsule

New Zealand Sponsor:
Douglas Pharmaceuticals Limited

Manufacturer:
Banner Pharmacaps (Canada) Limited, Olds, Alberta, Canada

Note: This consent is valid for two years from 26 November 2002.

Dated this 9th day of October 2002.

G. R. BOYD, Chief Advisor, Safety and Regulation (pursuant to delegation given by the Minister of Health on the 20th day of February 1997).

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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:
Caelyx

Active Ingredient:
Doxorubicin hydrochloride 2mg/mL

Dosage Form:
Concentrate for infusion

New Zealand Sponsor:
Schering-Plough Pty Ltd

Manufacturer:
Ben Venue Laboratories Inc, Bedford, Ohio, United States of America

Product:
Cancidas

Active Ingredient:
Caspofungin acetate 57.8mg equivalent to 50mg caspofungin anhydrous free base

Dosage Form:
Powder for infusion

New Zealand Sponsor:
Merck Sharp & Dohme (New Zealand) Limited

Manufacturer:
Merck & Co Inc, West Point, Pennsylvania, United States of America



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2002, No 154


Gazette.govt.nz PDF NZ Gazette 2002, No 154





✨ LLM interpretation of page content

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

πŸ₯ Health & Social Welfare
9 October 2002
Medicines Act, New Medicines, Lemsip Max Day & Night, X-Opaque HD
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Renewal of Provisional Consent to the Distribution of a New Medicine

πŸ₯ Health & Social Welfare
9 October 2002
Medicines Act, Provisional Consent, Serecid, Hydroxyzine hydrochloride
  • G. R. Boyd, Chief Advisor, Safety and Regulation

πŸ₯ Consent to the Distribution of Changed Medicines

πŸ₯ Health & Social Welfare
9 October 2002
Medicines Act, Changed Medicines, Caelyx, Cancidas
  • G. R. Boyd, Chief Advisor, Safety and Regulation