Product Name

RINVOQ EXTENDED-RELEASE TABLET 45MG

Active Ingredient

Upadacitinib Hemihydrate eqv Upadacitinib

Application type

NDA-3: New strength

Product Registrant

ABBVIE PTE LTD

Date of Approval

10 Feb 2023

Registration No.

SIN16687P

Indications:

RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Product Name

MENOPUR SOLUTION FOR INJECTION IN PRE-FILLED PEN 600 IU, 1200 IU

Active Ingredient

Menotrophin

Application type

NDA-2/3: New formulation, new strength

Product Registrant

Ferring Pharmaceuticals Private Limited

Date of Approval

20 Feb 2023

Registration No.

SIN16699P

SIN16700P

Indications:

MENOPUR® is indicated for the treatment of infertility in the following clinical situations:

Anovulation, including polycystic ovarian disease (PCOD), in women who have been unresponsive to treatment with clomiphene citrate.

Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART) (e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI).

Sterility in females with hypo- or normogonadotropic ovarian insufficiency: Stimulation of follicular growth.

Product Name

NURTEC ORALLY DISINTEGRATING TABLET 75MG

Active Ingredient

Rimegepant sulfate eqv Rimegepant

Application type

NDA-1: New chemical entity

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

21 Feb 2023

Registration No.

SIN16702P

NURTEC is indicated for the

• Acute treatment of migraine with or without aura in adults;

• Preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month.

Product Name

MAXIGESIC PE FILM-COATED TABLET

Active Ingredient

Paracetamol, phenylephrine hydrochloride, ibuprofen

Application type

NDA-2: New combination

Product Registrant

APEX PHARMA MARKETING PTE. LTD.

Date of Approval

21 Feb 2023

Registration No.

SIN16703P

Indications:

Maxigesic PE is used for temporary relief of cold and flu symptoms including:

• Headache

• Fever

• Pain

• Nasal congestion

Product Name

WEGOVY 1MG SOLUTION FOR INJECTION IN PRE-FILLED PEN

WEGOVY 0.5MG SOLUTION FOR INJECTION IN PRE-FILLED PEN

WEGOVY 0.25MG SOLUTION FOR INJECTION IN PRE-FILLED PEN

WEGOVY 1.7MG SOLUTION FOR INJECTION IN PRE-FILLED PEN

WEGOVY 2.4MG SOLUTION FOR INJECTION IN PRE-FILLED PEN

Active Ingredient

Semaglutide

Application type

NDA-2/3: New strength, new indication

Product Registrant

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Date of Approval

22 Feb 2023

Registration No.

SIN16704P

SIN16705P

SIN16706P

SIN16707P

SIN16708P

Indications:

Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of

• ≥30 kg/m2 (obesity), or

• ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g.dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

Product Name

NOVOEIGHT POWDER AND SOLVENT FOR SOLUTION

FOR INJECTION 2000IU/VIAL

Active Ingredient

Turoctocog Alfa

Application type

NDA-3: New strength

Product Registrant

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Date of Approval

24 Feb 2023

Registration No.

SIN16713P

Indications:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

NovoEight® does not contain Willebrand factor and is not indicated in von Willebrand disease. NovoEight® can be used for all age groups.