New Zealand Gazette – 2012 – No. 116

Page 3363

✨ Medicine Distribution Consents

20 SEPTEMBER 2012 NEW ZEALAND GAZETTE, No. 116 3363

Product: Ranitidine Relief
Active Ingredient: Ranitidine hydrochloride 167.5mg equivalent to Ranitidine 150mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Karnataka, India

Product: Ranitidine Relief
Active Ingredient: Ranitidine hydrochloride 335mg equivalent to Ranitidine 300mg
Dosage Form: Film coated tablet
New Zealand Sponsor: Mylan New Zealand Limited
Manufacturer: Adcock Ingram Limited - A Medreich Group Company, Karnataka, India

Product: Strepsils Children 6+ Orange
Active Ingredients:
Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Dosage Form: Lozenge
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, United Kingdom

Product: Strepsils Children 6+ Sugar Free Strawberry
Active Ingredients:
Amylmetacresol 0.6mg
Dichlorobenzyl alcohol 1.2mg
Dosage Form: Lozenge
New Zealand Sponsor: Reckitt Benckiser (New Zealand) Limited
Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, United Kingdom

Dated this 13th day of September 2012.

DR STEWART JESSAMINE, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health (pursuant to delegation given by the Minister of Health on 6 July 2001).

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Renewal of Provisional Consent to the Distribution of Medicines

Pursuant to section 23(4A) of the Medicines Act 1981, the Minister of Health hereby renews the provisional consent to the sale, supply or use in New Zealand of the medicine set out in the Schedule hereto:

Schedule

Product: Thalomid
Active Ingredient: Thalidomide 50mg
Dosage Form: Capsule
New Zealand Sponsor: Celgene Limited
Manufacturers:
Institute of Drug Technology (Aust) Limited, Boronia, Australia
Penn Pharmaceutical Services Limited, Gwent, United Kingdom
Celgene International Sarl, Boudry, Switzerland

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

Thalidomide may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope and practice of internal medicine.
Celgene Limited will manage the risk management programme relating to the distribution and use of Thalomid.

Note: This renewed consent is valid for two years from 25 November 2012.

Product: Thalomid
Active Ingredient: Thalidomide 100mg
Dosage Form: Capsule
New Zealand Sponsor: Celgene Limited
Manufacturers:
Institute of Drug Technology (Aust) Limited, Boronia, Australia
Penn Pharmaceutical Services Limited, Gwent, United Kingdom
Celgene International Sarl, Boudry, Switzerland

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

Thalidomide may only be prescribed by registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 and who are certified as competent by the Medical Council of New Zealand in the scope and practice of internal medicine.
Celgene Limited will manage the risk management programme relating to the distribution and use of Thalomid.

Note: This renewed consent is valid for two years from 25 November 2012.

Gazette.govt.nz — NZ Gazette 2012, No 116

The General Assembly Library (on the right) was completed in 1899 and survived the 1907 fire. Now the oldest remaining original Parliament building, still used as the Parliamentary Library.

✨ LLM interpretation of page content

🏥 Consent to the Distribution of New Medicines

Domain🏥 Health & Social Welfare
Dated13 September 2012
KeywordsMedicines Act 1981, New Medicines, Distribution Consent
👩‍💼 Officials

DR STEWART JESSAMINE, Acting Chief Medical Officer, Clinical Leadership, Protection and Regulation Business Unit, Ministry of Health

🏥 Renewal of Provisional Consent to the Distribution of Medicines

Domain🏥 Health & Social Welfare
KeywordsMedicines Act 1981, Thalidomide, Provisional Consent Renewal
👩‍💼 Officials

The Minister of Health

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