Name, ingredients & presentation
Trade name, active ingredient, strengths, excipients, and presentation forms.
Drug name
- Generic name: Inpegsomatropin Injection
- Trade name: Pegpesen®
- Active ingredient: Inpegsomatropin
Molecular characteristics
- Molecular formula (as stated): C998H1541N2630O304S7[C2H4O]2n (n = 400–500)
- Molecular weight: 57–67 kDa
Excipients
Mannitol, sodium acetate, glacial acetic acid, sodium chloride, lysine acetate. Free of preservatives.
Character
This product is a clear liquid.
Indications
Pegpesen® is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
Strengths & packaging
Prefilled syringe (PFS)
- 2.5 mg (0.35 mL)/PFS
- 3.0 mg (0.35 mL)/PFS
- 3.5 mg (0.35 mL)/PFS
- 5.0 mg (0.5 mL)/PFS
Prefilled syringe with cartridge: 1 PFS/box. Prefilled syringe: 1 PFS/box.
Vial
- 2.0 mg (0.5 mL)/vial — 1 vial/box
Shelf life & storage
- Shelf life: 18 months
- Storage & transport: 2–8 °C, protect from light. Do not freeze or shake violently.
China registration identifiers
The following approval numbers apply to the Chinese market only.
| Presentation | Strength | NMPA China approval no. |
|---|---|---|
| PFS | 2.5 mg (0.35 mL) | S20250026 |
| PFS | 3.0 mg (0.35 mL) | S20250027 |
| PFS | 3.5 mg (0.35 mL) | S20250028 |
| PFS | 5.0 mg (0.5 mL) | S20250029 |
| Vial | 2.0 mg (0.5 mL) | S20250025 |
Executive standard: YBS00322025
Marketing authorization holder & manufacturer
Xiamen Amoytop Biotech Co., Ltd.
Registered / manufacturing address: No. 330, Wengjiao Road, Xinyang
Industrial Zone, Haicang, Xiamen, Fujian, P.R. China · Postal code 361028
Tel +86-400-880-6621 · Fax +86-592-5156558 · www.amoytop.com
Email for adverse reaction reporting: [email protected]