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Applications received for new investments since 1 November 2008 Details of Funding Applications received are published on PHARMAC’s website, in accordance with the Terms of Reference for the Pharmacology and Therapeutics Advisory Committee (PTAC) and PTAC Subcommittees 2008. Applications Received Since November 2008 Chemical (Trade) names Varenicline (Champix) Erlotinib (Tarceva) Losartan Gefitinib (Iressa) Rosuvastatin (Crestor) Etanercept (Enbrel) Palivizumab (Syngagis) Cyclosporin Travoprost/timolol (Duotrav) Deferiprone (Ferriprox) Gluten free foods Folic Acid
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Indication Smoking cessation Non small-cell lung cancer Review of Special Authority criteria for congestive heart failure or hypertension Non small-cell lung cancer Hyperlipdaemia Severe chronic plaque psoriasis Respiratory syncytial virus Amendment of SA for steroid resistant nephrotic syndrome Glaucoma Iron overload in thalassaemia major patients Amendment to SA biopsy requirement Prevention of neural tube defects
Applicant Pfizer Astra Zeneca AstraZeneca AstraZeneca AstraZeneca Wyeth Waikato DHB Individual Alcon Orphan Individual Ministry of Health
Date Received 5/12/2008 5/12/2008 8/12/2008 8/12/2008 9/12/2008 9/12/2008 9/12/2008 9/12/2008 5/12/2008 9/12/2008 9/12/2008 9/12/2008
Chemical (Trade) names Gemcitabine (Gemzar) Paliperidone (Invega) Olanzapine (Zyprexa Adhera) Buprenorphine (Norspan) Sitagliptin (Januvia) Sitagliptin and metformin (Janumet) Riluzole (Rilutek) Sorafenib (Nexavar) Thalidomide (Thalidomide Pharmion) Budesonide (Entocort) Lenalidomide (Revlimid) Vildagliptin (Galvus) Aliskirin (Rasilez) Cox-2 inhibitors Ambrisentan (Volibris)
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Indication Pancreatic cancer Schizophrenia Schizophrenia Moderate to severe pain Type 2 diabetes mellitus Type 2 diabetes mellitus Amyotrophic lateral sclerosis Hepatocellular carcinoma Multiple Myeloma Chron’s disease Multiple Myeloma Type 2 diabetes mellitus Hypertension Pain Pulmonary arterial hypertension
Applicant New Zealand Association of Cancer Specialists Janssen-Cilag Eli Lilly Mundipharma Merck Sharp & Dohme Merck Sharp & Dohme Sanofi-Aventis Bayer Celgene New Zealand Society of Gastroenterology Celgene Novartis Novartis New Zealand Haemophilia Treaters Group Glaxo
Date Received 11/12/2008 11/03/2009 6/03/2009 9/03/2009 20/04/2009 20/04/2009 28/05/2009 8/06/2009 11/06/2009 11/06/2009 12/06/2009 12/06/2009 16/06/2009 16/06/2009 17/06/2009
Chemical (Trade) names Insulin glulisine (Apidra) Gluten free multi-seed bread mix Etravirine (Intelence) Rivaroxaban (Xarelto) Budesonide/eformoterol (Symbicort Turbuhaler) Sunitinib (Sutent)
Indication Type 1 and 2 diabetes Gluten intolerance Antiretroviral for HIV Venous thromboembolism prophylaxis. Asthma Advanced renal cell carcinoma
Applicant Sanofi Aventis Bakels Janssen-Cilag Bayer AstraZeneca Pfizer Gastrointestinal Cancer Special Interest Group of the New Zealand Association of Cancer Specialists Individual Wyeth Gastro-Intestinal Special Interest Group Individuals
Date Received 15/06/2009 1/07/2009 03/09/2009 09/09/2009 15/09/2009 15/09/2009
Gemcitabine (Gemzar)
Pancreatic cancer
15/09/2009
Dornase alpha Milk substitute formula (S-26 Gold premgro) Gemcitabine Naltrexone Docetaxel Oral supplementary food (Enprocal) Bevacizumab (Avastin)
Cystic fibrosis Premature infants Cholangiocarcinoma Alcohol addiction Early breast cancer Malnutrition and physical frailty Metastatic colorectal cancer
15/09/2009 19/10/2009 21/10/2009 30/10/2009
New Zealand Breast Cancer 11/11/2009 Special Interest Group Warrnambool Roche 03/12/2009 07/12/2009
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Chemical (Trade) names Imiquimod (Aldara) Multiple sclerosis treatments Bortezomib (Velcade) Prasugrel (Effient) Isopropyl alcohol and anhydrous glycerine (Ear clear) Losartan (Cozaar, Hyzaar) Levofloxacin Tenofovir/emtricitabine (Truvada) Tenofovir/emtricitabine/efavirenz (Atripla) Teriparatide (Forteo)
Indication Actinic keratosis. Multiple sclerosis Multiple myeloma. Acute coronary syndromes Prevention of swimmers ear Gout Helicobacter pylori HIV HIV Osteoporosis
Applicant Douglas Individual Janssen-Cilag Eli Lilly Key Pharmaceuticals Ngā Kaitiaki o Te Puna Rongoā o Aotearoa Clinician Gilead Gilead Eli Lilly
Date Received 07/12/2009 07/12/2009 07/12/2009 08/12/2009 08/12/2009 30/12/2009 16/02/2010 26/02/2010 26/02/2010 01/03/2010
Sildenafil (Viagra)
Persistent pulmonary hypertension of the newborn with associated lung disease; Clinician congenital diaphragmatic hernia; chronic neonatal lung disease Chronic lymphocytic leukaemia Bacterial vaginosis Vitamin D deficiency Roche Douglas Pharmaceuticals Limited Wilson Consumer Products
04/03/2010
Rituximab (Mabthera) Metronidazole (Zidoval Gel) Vitamin D (OsteoVit-D)
8/03/2010 8/03/2010 9/03/2010
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Chemical (Trade) names Vitamin D and calcium (OsteoVit-D & Calcium) Golimumab (Simponi) Darunavir (Prezista) Levonorgestrel micronizado (Jadelle) Sildenafil Hydrolysed rice protein formula (Risolac)
Indication Vitamin D deficiency and osteoporosis Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis HIV Long-acting contraception Pulmonary arterial hypertension Food allergies
Applicant Wilson Consumer Products Merck Sharpe and Dohme Janssen-Cilag Bayer Individual Heinz Watties Nutricia Nutricia Nutricia Nutricia Nutricia Nutricia Nutricia Nutricia
Date Received 9/03/2010 09/03/2010 9/03/2010 09/03/2010 12/04/2010 21/04/2010 23/04/2010 23/04/2010 23/04/2010 23/04/2010 23/04/2010 23/04/2010 23/04/2010 23/04/2010 04/05/2010
Oral nutritional feed (Fortisip compact) Malnutrition Paediatric oral feed (Infatrini) Paediatric oral feed (Nutrini Energy Multi Fibre) Paediatric oral feed (Nutrini Low Energy Multi Fibre) Infants with increased nutritional requirements Disease related malnutrition Enteral nutritional support
Oral nutritional supplement (Fortijuce) Malnutrition Paediatric oral feed (Neocate Nutra) Ketogenic supplement (KetoCal) Oral nutritional supplement (PKU Anamix Junior LQ) Elemental formula (Alfara)
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Food allergies Chronic intractable epilepsy Phenylketonuria
Gastrointestinal and other malabsorptive Nestle Nutrition problems
Chemical (Trade) names Bortezomib Naltrexone Pipobroman Multiple Sclerosis Treatments Prasugrel (Effient) Paliperidone (Invega) Azacitidine (Vidaza) Lacosamide (Vimpat) Deferasirox (Exjade) Quetiapine extended release (Seroquel XR) Riluzole (Rilutek) Sitagliptin/metformin (Januvia/Janumet) Dabigatran (Pradaxa) Varenicline (Champix) Deferiprone (Ferriprox)
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Indication Multiple myeloma Henoch-schonlein purpura Polycythemia rubra vera and essential thrombocythaemia Multiple Sclerosis Acute coronary syndromes Schizophrenia Myelodysplastic syndrome Epilepsy Iron overload Schizophrenia Amyotrophic lateral sclerosis Diabetes Stroke, systemic embolism, atrial fibrillation Smoking cessation Iron overload
Applicant Individual Individual Individual Individual Eli Lilly Janssen-Cilag Celgene UCB Novartis AstraZeneca Sanofi Aventis Merck Sharp & Dohme Boehringer Ingelheim Pfizer Orphan
Date Received 5/05/2010 26/03/2010 31/03/2010 12/04/2010 3/05/2010 17/05/2010 18/05/2010 21/05/2010 25/05/2010 25/05/2010 25/05/2010 25/05/2010 25/05/2010 25/05/2010 21/06/2010
Chemical (Trade) names Imiglucerase Bortezomib Lapatinib Rifabutin Paracetamol and ibuprofen (Maxigesic) Miglustat (Zavesca) Fluticasone propionate / salmeterol xinafoate (Seretide) Adalimumab (Humira) Posaconazole (Noxafil) Nab-paclitaxel (Abraxane) Ivermectin Clodronate (Ostac) Mycophenolate Pazopanib (Votrient) Trastuzumab (Herceptin)
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Indication Gaucher’s disease AL amyloidosis HER 2 positive metastatic breast cancer H. Pylori Analgesia and fever reduction Type 1 Gaucher’s disease Asthma Juvenile idiopathic arthritis Aspergillus Advanced breast cancer Crusted scabies Osteoradionecrosis Severe atopic eczema Advanced and/or metastatic renal cell carcinoma Metastatic HER2 positive gastric cancer
Applicant Individual Individual
Date Received 6/07/2010 16/07/2010
New Zealand Breast Cancer 21/07/2010 Special Interest Group Individual AFT Pharmaceuticals Actelion Glaxo Smith Kline Abbott Merck Sharp & Dohme Specialised Therapeutics Individual Individual Individual GlaxoSmithKline Roche 27/07/2010 4/08/2010 17/08/2010 17/08/2010 17/08/2010 17/08/2010 17/08/2010 19/09/2010 19/10/2010 17/11/2010 23/11/2010 26/11/2010
Chemical (Trade) names Lapatinib (Tykerb) Docetaxel Mycophenolate Tiotropium bromide (Spiriva) Nilotinib (Tasigna) Olanzapine (Olanzaccord) Bortezomib Dabigatran (Pradaxa)
Indication HER2 positive metastatic breast cancer Metastatic castration resistant prostate cancer Lupus nephritis Chronic obstructive pulmonary disease Chronic myeloid leukaemia Psychoses First line multiple myeloma with cast nephropathy Stroke, systemic embolism, atrial fibrillation Contraception
Applicant GlaxoSmithKline Individual Individual Boehringer Ingelheim Novartis Airflow Products Clinician Boehringer Ingelheim Royal Australian and New Zealand College of Obstetricians and Gynaecologists Bayer Janssen-Cilag Roche
Date Received 29/11/2010 19/11/2010 29/11/2010 30/11/2010 22/12/2010 22/01/2011 26/01/2011 03/02/2011
Levonorgestrel (Mirena)
17/02/2011
Testosterone undecanoate (Reandron Testosterone replacement 1000) Ustekinumab (Stelara) Rituximab (Mabthera) Cevimeline Valganciclovir Psoriasis Relapsed/refractory follicular nonHodgkin’s lymphoma Dry mouth (including Sjogren’s syndrome) Cytomegalovirus
22/02/2011 22/02/2011 22/02/2011
Sjogren’s Syndrome Society 1/03/2011 of NZ Inc. Haematology Society 30/05/2011
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Chemical (Trade) names Fluticasone/salmeterol Pregabalin (Lyrica) Sorafenib (Nexavar) Everolimus (Afinitor) Sunitinib (Sutent) Gefitinib (Iressa) Ticagrelor (Brilinta) Tiotropium Bromide (Spiriva) Adalimumab (Humira) Saxagliptin (Onglyza) Tocilizumab (Actemra) Indacaterol (ONBREZ inhaler) Cetolizumab (Cimzia) Dutasteride (Avodart) Eltrombopag (Revolade)
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Indication Asthma Neuropathic pain Hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC) Advanced renal cell carcinoma (RCC) Gastrointestinal stromal tumour (GIST)
Applicant Individual Pfizer Bayer New Zealand Ltd Novartis New Zealand Ltd Pfizer
Date Received 30/05/2011 31/05/2011 30/08/2011 30/08/2011 30/08/2011 30/08/2011 30/08/2011 30/08/2011 30/08/2011 30/08/2011 30/08/2011 30/08/2011 22/11/2011 22/11/2011 22/11/2011
Locally advanced or metastatic non small AstraZeneca cell lung cancer (NSCLC) Acute coronary syndromes Ammendment to SA for chronic obstructive pulmonary disease Crohn’s disease Type II diabetes Rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis (sJIA) Chronic obstructive pulmonary disease Rheumatoid arthritis Benign prostatic hyperplasia Idiopathic Thrombocytoponic Purpura (ITP) AstraZeneca Boehringer Ingleheim Abbott Laboratories NZ AstraZeneca Roche Products (New Zealand) Ltd Novartis UCB GlaxoSmithKline GlaxoSmithKline
Chemical (Trade) names Erlotinib (Tarceva) Fingolimod (Gilenya) Telaprevir (Incivo)
Indication Non-small cell lung cancer with EGFR activating mutation Multiple Sclerosis Hepatitis C
Applicant Roche Novartis Janssen-Cliag Pty Ltd
Date Received 22/11/2011 22/11/2011 22/11/2011
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Metadata
Title
Applications received since 1 November 2008
Abstract
Applications received for new investments since 1 November 2008 Details of Funding Applications received are published on PHARMAC’s website, in accordance with the Terms of Reference for the Pharmacology and Therapeutics Advisory Committee (PTAC) and PTAC Subcommittees 2008. Applications Received…
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