New Zealand Gazette – 1994 – No. 91

Page 2784

✨ Medicines Distribution Consents

2784
NEW ZEALAND GAZETTE
No. 91

Schedule

Name and Strength	Form	Name and Address of Manufacturer	Proprietary Name (if any)
Spirapril 6 mg	Tablet	Sandoz Pharma Limited, Basle, Switzerland	Sandopril
Diclofenac sodium 100 mg	Tablet (sustained release)	Laboratoria Wolfs B V B A, Antwerp, Belgium	Difen SR
Selegiline hydrochloride 5 mg	Tablet	Apotex Inc., Weston, Ontario, Canada	Apo-Selegiline
Nifedipine 10 mg	Tablet	Hexal-Pharma GmbH, Holzkirchen, Germany	Fedrem
Flecainide acetate 50 mg	Capsule	Pacific Pharmaceuticals Limited, Mt Wellington, Auckland	Tabco 50
Note: Not to be marketed as substitutable for any other flecainide acetate product as if the two (2) products were bioequivalent.
Flecainide acetate 100 mg	Tablet	Pacific Pharmaceuticals Limited, Mt Wellington, Auckland	Tabco 100
Note: Not to be marketed as substitutable for any other flecainide acetate product as if the two (2) products were bioequivalent.
Rocuronium bromide 50 mg in 5 ml, 100 mg in 10 ml	Injection	N V Organon, Oss, The Netherlands and Organon Laboratories Limited, Newhouse, Motherwell, Lanarkshire, Scotland	Esmeron

Dated this 2nd day of September 1994.

C. LOVELACE, Director-General of Health, pursuant to delegation given by the Minister of Health on the 25th day of June 1993.

g06649

Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 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

Name and Strength	Form	Name and Address of Manufacturer	Proprietary Name (if any)
Pentastarch 10%	Solution for infusion	Nederlands Productielaboratorium Voor Bloedtransfusieapparatuur en Infusieevloeistoffen BV (NPBI BV), Emmer-Compascuum, The Netherlands	Pentaspan

Dated this 31st day of August 1994.

C. LOVELACE, Director-General of Health, pursuant to delegation given by the Minister of Health on the 25th day of June 1993.

g06651

Provisional Consent to the Distribution of a New Medicine

Pursuant to section 23 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

Name and Strength	Form	Name and Address of Manufacturer	Proprietary Name (if any)
300 mcg Anti D (Rh₀) Immunoglobulin (>820IU)	Solution for IM injection	Ortho Diagnostics Inc., Raritan, New Jersey, United States of America	RhoGAM

Conditions:

The above provisional consent is valid for six (6) months from the date of publication of this notice.
The health care professional who prescribes or administers RhoGAM must report its use to Auckland Healthcare Limited on a standardised form. The standardised form must contain the name and address of the health care professional and patient, and the reason, place and date of administration.
On a monthly basis, Auckland Healthcare Limited are required to forward the user information forms to the Ministry of Health along with information detailing the amounts of RhoGAM distributed and the sites to which it was distributed.

Dated this 1st day of September 1994.

C. LOVELACE, Director-General of Health, pursuant to delegation given by the Minister of Health on the 25th day of June 1993.

g06652

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VUW Te Waharoa — NZ Gazette 1994, No 91

NZLII — NZ Gazette 1994, No 91

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 (continued from previous page)

Domain🏥 Health & Social Welfare
Dated2 September 1994
KeywordsMedicines, Distribution, Consent, Medicines Act 1981
👩‍💼 Officials

C. Lovelace, Director-General of Health

🏥 Provisional Consent to the Distribution of Pentastarch 10%

Domain🏥 Health & Social Welfare
Dated31 August 1994
KeywordsMedicines, Distribution, Consent, Pentastarch, Medicines Act 1981
👩‍💼 Officials

C. Lovelace, Director-General of Health

🏥 Provisional Consent to the Distribution of RhoGAM

Domain🏥 Health & Social Welfare
Dated1 September 1994
KeywordsMedicines, Distribution, Consent, RhoGAM, Medicines Act 1981
👩‍💼 Officials

C. Lovelace, Director-General of Health

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