Notice Type
Departmental
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 inNew 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 (Rh[in'O']) Immunoglobulin (<mt>820IU) Solution for IM injection Ortho Diagnostics Inc., Raritan, New Jersey, United States of America RhoGAM Conditions: 1. The above provisional consent is valid for six (6) months from the date of publication of this notice. 2. 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. 3. 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.
Publication Date
8 Sep 1994

Notice Number

1994-go6652

Page Number

2784