This report lists applications approved during the period as indicated above. It includes first new drug application of an innovator product and first combination, dosage form or new usage of an innovator product. The list also includes new indication approved for an existing medicinal product.
NEW DRUG APPROVALS
| PRODUCT NAME |
| HALAVEN SOLUTION FOR INJECTION 0.5MG/ML |
| EVICEL FIBRIN SEALANT (HUMAN) SOLUTION |
| MENACTRA SOLUTION FOR INJECTION |
NEW INDICATION APPROVALS
| PRODUCT NAME |
| TARCEVA TABLET 150MG |
| XYLOCAINE 2% WITH ADRENALINE 1:80000 INJECTION |
NEW DRUG APPROVALS
Product Name | |
Active Ingredient | eribulin mesylate |
Licence Holder | EISAI (SINGAPORE) PTE LTD |
Date of Approval | 8 Feb 2011 |
Licence No. | SIN13917P |
Indications: Halaven is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. | |
Product Name | |
Active Ingredient | human fibrinogen and thrombin |
Licence Holder | JOHNSON & JOHNSON PTE LTD |
Date of Approval | 23 Feb 2011 |
Licence No. | SIN13921P |
Indications: Evicel is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis (see section 5.1). Evicel is also indicated as suture support for haemostasis in vascular surgery. | |
Product Name | |
Active Ingredient | meningococcal (serogroup A) polysaccharide (monovalent conjugate) meningococcal (serogroup C) polysaccharide (monovalent conjugate) meningococcal (serogroup W-135) polysaccharide (monovalent conjugate) meningococcal (serogroup Y) polysaccharide (monovalent conjugate) diphtheria toxoid protein |
Licence Holder | SANOFI-AVENTIS SINGAPORE PTE LTD |
Date of Approval | 24 Feb 2011 |
Licence No. | SIN13922P |
Indications: Menactra vaccine is indicated for active immunization of individuals 2 through 55 years of age for the prevention of invasive meningococcal disease caused by N meningitidis serogroups A, C, Y and W-135. Menactra vaccine is not indicated for the prevention of meningitis caused by other microorganisms or for the prevention of invasive meningococcal disease caused by N meningitidis serogroup B. Menactra vaccine is not indicated for treatment of meningococcal infections. Menactra vaccine is not indicated for immunization against diphtheria. Menactra vaccine may not protect 100% of individuals. | |
NEW INDICATION APPROVALS
Product Name | |
Active Ingredient | erlotinib hydrochloride |
Licence Holder | ROCHE SINGAPORE PTE LTD |
Date of Approval | 10 Feb 2011 |
Indications: Non-small cell lung cancer: Tarceva is indicated as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease after 4 cycles of standard platinum-based first-line chemotherapy. Tarceva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-negative tumours. Pancreatic cancer: Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer. | |
Product Name | |
Active Ingredient | adrenaline acid tartrate and ligocaine hydrochloride anhydrous |
Licence Holder | DENTSPLY (SINGAPORE) PTE LTD |
Date of Approval | 16 Feb 2011 |
Indications: Xylocaine 2% with Adrenaline 1:80,000 is a local anaesthetic solution for use in dental infiltration anaesthesia and all dental nerve block techniques. | |
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