New Zealand Gazette – 2005 – No. 1

Page 30

✨ Medicines Distribution Consent

30 NEW ZEALAND GAZETTE, No. 1
13 JANUARY 2005

Product: Strattera
Active Ingredient: Atomoxetine hydrochloride 68.56mg equivalent to 60mg atomoxetine free base
Dosage Form: Capsule
New Zealand Sponsor: Eli Lilly and Company (NZ) Limited
Manufacturer: Lilly del Caribe, Inc., Carolina, Puerto Rico

Product: Suboxone
Active Ingredients: Buprenorphine hydrochloride 2.16mg equivalent to 2mg buprenorphine
Naloxone hydrochloride dihydrate 0.61mg equivalent to 0.5mg naloxone
Dosage Form: Sublingual tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom

Product: Suboxone
Active Ingredients: Buprenorphine hydrochloride 8.64mg equivalent to 8mg buprenorphine
Naloxone hydrochloride dihydrate 2.44mg equivalent to 2mg naloxone
Dosage Form: Sublingual tablet
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Hull, North Humberside, United Kingdom

Product: Vfend
Active Ingredient: Voriconazole 40mg/mL
Dosage Form: Powder for oral suspension
New Zealand Sponsor: Pfizer New Zealand Limited
Manufacturer: Pfizer PGM, Poca Sur Cisse, France

Dated this 6th day of January 2005.

BARRY BORMAN, acting as Deputy Director-General, Public Health, for the period 5 January 2005 to 24 January 2005
(pursuant to delegation given by the Minister of Health on 6 July 2001).

go157

Provisional Consent to the Distribution of New Medicines

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 medicines set out in the Schedule hereto:

Schedule

Product: Clopine
Active Ingredient: Clozapine 200mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals Limited, Central Park Drive, Lincoln, Auckland

Note: This consent is given subject to the following conditions:

The medicine may only be prescribed by:
– medical practitioners who are vocationally registered under the Medical Practitioners Act 1995 in the branches of psychological medicine or psychiatry; and
– medical practitioners employed as registrars in psychological medicine or psychiatry who are under the supervision of persons of the kind referred to above.
Persons prescribing the medicine must comply with the requirements of the New Zealand Guidelines for the Use of Atypical Anti-Psychotic Drugs (Second Edition September 1998) and the requirements of local hospital and health service protocols for the use of clozapine.

Note: This consent is valid for two years from the date of publication of this notice.

Product: Clopine
Active Ingredient: Clozapine 50mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Pharmaceuticals Limited, Central Park Drive, Lincoln, Auckland

Note: This consent is given subject to the following conditions:

The medicine may only be prescribed by:
– medical practitioners who are vocationally registered under the Medical Practitioners Act 1995 in the branches of psychological medicine or psychiatry; and
– medical practitioners employed as registrars in psychological medicine or psychiatry who are under the supervision of persons of the kind referred to above.

VUW Te Waharoa — NZ Gazette 2005, No 1

Gazette.govt.nz — NZ Gazette 2005, No 1

Parliament House (depicted) was completed in 1918 and remains the primary seat of Parliament.

✨ LLM interpretation of page content

🏥 Consent to Distribution of New Medicines (continued from previous page)

Domain🏥 Health & Social Welfare
Dated6 January 2005
KeywordsMedicines Act, New Medicines, Distribution Consent, Strattera, Suboxone, Vfend
👩‍💼 Officials

BARRY BORMAN, acting as Deputy Director-General, Public Health

🏥 Provisional Consent to the Distribution of New Medicines

Domain🏥 Health & Social Welfare
KeywordsMedicines Act, Provisional Consent, Clopine, Clozapine

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