New drug indication approval - July 2024
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| Product Name | GLYPRESSIN SOLUTION FOR INJECTION, 1 MG/8.5 ML |
| Active Ingredient (Strength) | Terlipressin 0.85 mg/8.5 ml eqv Terlipressin acetate(1 mg/8.5 ml) |
| Product Registrant | FERRING PHARMACEUTICALS PRIVATE LIMITED |
| Date of Approval | 10/07/2024 |
Indications:
Treatment of patients with hepatorenal syndrome (HRS) Type 1 who are actively being considered for liver transplant (see sections 4.2 and 4.4 on the risks in special populations). |
| Product Name | REXULTI FILM-COATED TABLETS 0.5MG,
REXULTI FILM-COATED TABLETS 1MG,
REXULTI FILM-COATED TABLETS 2MG,
REXULTI FILM-COATED TABLETS 3MG |
| Active Ingredient (Strength) | BREXPIPRAZOLE(0.5mg),
BREXPIPRAZOLE(1mg),
BREXPIPRAZOLE(2mg),
BREXPIPRAZOLE(3mg) |
| Product Registrant | LUNDBECK SINGAPORE PTE. LTD. |
| Date of Approval | 24/07/2024 |
Indications:
Treatment of agitation associated with Alzheimer’s dementia (AAD), who are unresponsive to non-pharmacological interventions. |
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| Product Name | PREVYMIS CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML,
PREVYMIS FILM COATED TABLET 240MG,
PREVYMIS FILM COATED TABLET 480MG |
| Active Ingredient (Strength) | Letermovir(20mg/ml),
Letermovir(240.0mg),
Letermovir(480.0mg) |
| Product Registrant | MSD PHARMA (SINGAPORE) PTE. LTD. |
| Date of Approval | 01/07/2024 |
Indications:
Prevymis is indicated for prophylaxis of CMV disease in CMV-seronegative adults who have received a kidney transplant from a CMV-seropositive donor [D+/R-]. |
| Product Name | HYRIMOZ SOLUTION FOR INJECTION IN PRE-FILLED PEN 40MG/0.8ML |
| Active Ingredient (Strength) | Adalimumab(40 mg/0.8 mL) |
| Product Registrant | NOVARTIS (SINGAPORE) PTE LTD |
| Date of Approval | 18/07/2024 |
Indications:
Pediatric Ulcerative Colitis
Hyrimoz is indicated for inducing and maintaining clinical remission in pediatric patients 5 years of age or older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. |
| Product Name | ULTRAVIST 300 INJECTION 300MG IODINE/ML
ULTRAVIST 370 INJECTION 370MG IODINE/ML |
| Active Ingredient (Strength) | Iopromide eqv iodine (300mg/ml), Iopromide eqv iodine (370mg/ml) |
| Product Registrant | BAYER (SOUTH EAST ASIA) PTE LTD |
| Date of Approval | 27/07/2024 |
Indications:
For use in contrast-enhanced mammography to assess and detect known or suspicious lesions of the breast in adult women as an adjunct to mammography (with or without ultrasound). |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Indication Approvals