New Zealand Gazette – 1999 – No. 101

Page 2425

✨ Medicines Act Notices

26 AUGUST NEW ZEALAND GAZETTE 2425

Medicines Act 1981

Consent to the Distribution of a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product: Ciproxin HC Otic Drops.

Active Ingredient(s): Ciprofloxacin hydrochloride 2.33 mg equivalent to 0.2% ciprofloxacin.
Hydrocortisone 10 mg equivalent to 1% hydrocortisone.

Dosage Form: Ear drops.

NZ Sponsor: Bayer New Zealand Limited Health Care Division.

Manufacturer(s): Bayer Corporation, Myerstown, Pennsylvania, United States of America.

Product: Infanrix-Hib vaccine (Combination Product).

Active Ingredient(s): Tetanus toxoid 40IU.
Diphtheria toxoid (adsorbed) 30 IU.
Detoxified pertussis toxin 25 µg.
Pertussis filamentous haemagglutinin 25 µg.
Pertactin 8 µg.

Dosage Form: Suspension for injection.

Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium.

Active Ingredient(s): Haemophilus influenzae vaccine (tetanus toxoid conjugate) 10 µg.

Dosage Form: Powder for injection.

Manufacturer(s): SmithKline Beecham Biologicals SA, Rixensart, Belgium.

NZ Sponsor: SmithKline Beecham (NZ) Limited.

Product: Lactulose Syrup.

Active Ingredient(s): Lactulose 667 mg/mL.

Dosage Form: Oral solution.

NZ Sponsor: Technilab Inc.

Manufacturer(s): Technilab Inc, Lapointe, Mirabel, Quebec, Canada.

Product: Naprosyn.

Active Ingredient(s): Naproxen 25 mg/mL.

Dosage Form: Oral suspension.

NZ Sponsor: Roche Products (New Zealand) Limited.

Manufacturer(s): Roche Products Limited, Stepfield, Witham, Essex, United Kingdom.

Product: Priorix.

Active Ingredient(s): Rubella virus (Wistar RA27/3 strain) 1,000 CCID50.
Measles vaccine (Schwarz strain) 1,000 CCID50.
Mumps virus, live attenuated (RIT 4385) 5,012 CCID50.

Dosage Form: Powder for injection.

NZ Sponsor: SmithKline Beecham (NZ) Limited.

Manufacturer(s): Sachsisches Serumwerk Dresden, Branch of SKB Pharma GmbH, Dresden, Germany.
SmithKline Beecham Biologicals SA, Rixensart, Belgium.
SmithKline Beecham Biologicals SA, Genval, Belgium.

Dated this 18th day of August 1999.

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 a New Medicine

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Product: Isopto Fenicol.

Active Ingredient(s): Chloramphenicol 5 mg/mL.

Dosage Form: Eye drops, solution.

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VUW Te Waharoa — NZ Gazette 1999, No 101

NZLII — NZ Gazette 1999, No 101

The Executive Wing of Parliament (depicted) is universally known as The Beehive. It was completed in 1977 and remains the primary office for the elected Government of the day.

✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

Domain🏥 Health & Social Welfare
Dated18 August 1999
KeywordsMedicines Act 1981, New Medicine, Distribution Consent, Ear Drops, Vaccine, Oral Solution, Oral Suspension, Powder for Injection
👩‍💼 Officials

G. R. Boyd, Chief Advisor, Safety and Regulation

🏥 Consent to the Distribution of a New Medicine

Domain🏥 Health & Social Welfare
KeywordsMedicines Act 1981, New Medicine, Distribution Consent, Eye Drops

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