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 Name and Strength Form Name and Address of Manufacturer Proprietary Name(if any) 300 mcg Anti D (Rh[in'o']) Immunoglobulin ( 820IU) Solution for IM injection Ortho Diagnostic Systems Inc., Raritan, New Jersey, United States of America RhoGam Conditions: 1. This provisional consent is valid for twelve (12) 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 10th day of May 1996. HUGH BABER, Assistant General Manager, Health Regulation and Protection, pursuant to delegation given by the Minister of Health on the 18th day of January 1996.