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) Alglucerase 10 U/mL, 80 U/mL in 5 mL Note: This consent is valid for 2 years from the 30th day of November 1997. Solution, infusion, bottle Genzyme Corporation, Cambridge, Massachusetts, United States of America Ceredase 300 g Anti D (Rh) immunoglobulin ( 820 IU) in 15 mL Note: This consent is valid for 2 years from the 16th day of May 1997. Solution for IM injection, pre-filled syringe Ortho Diagnostic Systems Inc., Raritan, New Jersey, United States of America RhoGam Conditions: 1. The health care professional who prescribes or administers RhoGam must report its use to CSL (New Zealand) Limited (Bioplasma) 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. 2. On a monthly basis, CSL (New Zealand) Limited (Bioplasma) 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 24th day of November 1997. G. R. BOYD, Chief Advisor, Regulation and Safety, pursuant to delegation given by the Minister of Health on the 20th day of February 1997.