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HSA Approval

SOGROYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 10MG/1.5ML

SIN17217P

SOGROYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 10MG/1.5ML

SOGROYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 10MG/1.5ML

April 14, 2025

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantNOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SOLUTION

SUBCUTANEOUS

Medical Information

H01AC07

Manufacturer Information

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Novo Nordisk A/S (Formulation, Filling and Primary packager)

Active Ingredients

Somapacitan

10mg/1.5ml

Somapacitan

Documents

Package Inserts

Sogroya Solution for Injection in PFP 10mg per 1.5ml PI and IFU.pdf

Approved: April 14, 2025

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SOGROYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 10MG/1.5ML - HSA Approval | MedPath