Human Immunoglobulin (pH4) for Intravenous Injection
Formulation (FDF) · Injection · 1.25g/vial (5%, 25mL); 2.5g/vial (5%, 50mL); 5g/vial (5%, 100mL)
Formulation (FDF)Confidentiality:Public
- INN / Generic Name
- Human Immunoglobulin (pH4) for Intravenous Injection
- Dosage Form
- Injection
- Strength
- 1.25g/vial (5%, 25mL); 2.5g/vial (5%, 50mL); 5g/vial (5%, 100mL)
- Therapy Area
- Immunology & Inflammation
- Indication
- Primary immunodeficiency; Secondary immunodeficiency; Autoimmune disorder
- Current Status
- Official FDF licensing catalog (UB128)
- GMP Certification
- CN - NMPA
- CEP
- No
- DMF Type
- —
- Stability Data
- —
- BE Required
- Not required / waivable
- Registration Pathway
- Registered (market rights transferable / DCP·NP per market)
- MOQ
- On request
- Lead Time
- On request
- Price Range
- On request
HS Code
3002.15
Registrable Markets
To be assessed
Process / Sequence / Exact Price
- Process Summary
- —
- Exact Price