Skip to main content

New Drug Indication Approval - Nov 2018

Product Name	RELVAR ELLIPTA INHALATION POWDER 100MCG/25MCG, 200MCG/25MCG
Active Ingredient	Fluticasone Furoate/ Vilanterol Trifenatate
Product Registrant	GLAXOSMITHKLINE PTE LTD
Date of Approval	01 Nov 2018
Indications: ASTHMA RELVAR ELLIPTA is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting beta2-agonists. patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2 agonist

Product Name	SYNAZE NASAL SPRAY
Active Ingredient	Azelastine hydrochloride, Fluticasone propionate
Product Registrant	PHARMLINE MARKETING PTE LTD
Date of Approval	07 Nov 2018
Indications: Symptomatic treatment of moderate to severe allergic rhinitis and rhino-conjunctivitis in adults and children 6 years and older where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate.

Product Name	PERJETA CONCENTRATE FOR SOLUTION FOR INFUSION 420MG/14ML
Active Ingredient	Pertuzumab
Product Registrant	ROCHE SINGAPORE PTE LTD
Date of Approval	12 Nov 2018
Indications: Perjeta is indicated for use in combination with Herceptin and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence (see section 3.1.2).

Product Name	KEYTRUDA SOLUTION FOR INFUSION 25MG/ML
Active Ingredient	Pembrolizumab
Product Registrant	MSD PHARMA (SINGAPORE) PTE LTD
Date of Approval	12 Nov 2018
Indications: Non-Small Cell Lung Carcinoma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of patients with refractory classical Hodgkin Lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. Urothelial Carcinoma KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥10% as determined by a validated test, and who are not eligible for cisplatin-containing chemotherapy. KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy.

Product Name	TARGOCID FOR INJECTION 200MG/VIAL
Active Ingredient	Teicoplanin
Product Registrant	SANOFI-AVENTIS SINGAPORE PTE LTD
Date of Approval	21 Nov 2018
Indications: Targocid is also indicated in adults as an alternative oral treatment for Clostridium difficile infection associated diarrhoea and colitis (CDAD).

Product Name	OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML
Active Ingredient	Nivolumab
Product Registrant	BRISTOL-MYERS SQUIBB (SINGAPORE) PTE LTD
Date of Approval	21 Nov 2018
Indications: Gastric / Gastroesophageal Junction (GEJ) Cancer Opdivo as monotherapy is indicated for the treatment of adult patients with unresectable locally advanced or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma after two or more prior systemic therapies.

Product Name	TAGRISSO TABLET 40MG AND 80MG
Active Ingredient	Osimertinib
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	29 Nov 2018
Indications: TAGRISSO (osimertinib) is indicated for: the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. the treatment of patients with locally advanced or metastatic EGFR T790M mutation positive NSCLC whose disease has progressed on or after EGFR TKI therapy. (See Clinical efficacy and safety section)

Healthcare professional, Therapeutic Products

Published: 30 Nov 2018

New Drug Indication Approvals