Tuberculin purified protein derivative
- Generic Name
- Tuberculin purified protein derivative
- Brand Names
- Aplisol, Tubersol
- Drug Type
- Biotech
- CAS Number
- 92129-86-7
- Unique Ingredient Identifier
- I7L8FKN87J
Overview
Tuberculin Purified Protein Derivative (PPD) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The diagnostic test is commonly referred to as the Mantoux test which serves to minimize the risk of transmission of infection with Mycobacterium tuberculosis through early diagnosis and appropriate therapeutic intervention. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis. It is included in the World Health Organization's List of Essential Medicines.
Background
Tuberculin Purified Protein Derivative (PPD) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The diagnostic test is commonly referred to as the Mantoux test which serves to minimize the risk of transmission of infection with Mycobacterium tuberculosis through early diagnosis and appropriate therapeutic intervention. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis. It is included in the World Health Organization's List of Essential Medicines.
Indication
Indicated as a diagnostic agent in Mantoux Test used to detect infection with Mycobacterium tuberculosis.
Associated Conditions
- Tuberculosis (TB)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/06/12 | Phase 3 | Recruiting | |||
2023/02/28 | Phase 4 | Active, not recruiting | |||
2021/08/31 | Early Phase 1 | Completed | |||
2001/08/31 | Not Applicable | Completed |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
INTRADERMAL | 5 [iU] in 0.1 mL | 2021/11/09 | 50090-0261 | ||
INTRADERMAL | 5 [iU] in 0.1 mL | 2021/11/09 | 50090-1668 | ||
INTRADERMAL | 5 [iU] in 0.1 mL | 2024/01/25 | 49281-752 | ||
INTRADERMAL | 5 [iU] in 0.1 mL | 2017/11/01 | 50090-1336 | ||
INTRADERMAL | 5 [iU] in 0.1 mL | 2017/11/01 | 42023-104 | ||
INTRADERMAL | 5 [iU] in 0.1 mL | 2013/05/22 | 54868-2972 | ||
TYA Pharmaceuticals | INTRADERMAL | 5 [iU] in 0.1 mL | 2015/07/09 | 64725-0104 | |
SUBLINGUAL | 30 [hp_X] in 1 mL | 2025/05/15 | 63479-1412 | ||
SUBLINGUAL | 30 [hp_X] in 1 mL | 2025/04/22 | 63479-1412 |
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
HSA Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
|---|---|---|---|---|---|
INJECTION | 0.4 mcg/ml | 1998/08/19 | SIN09944P | ||
INJECTION | 10 mcg/0.5 ml | 2003/05/07 | SIN12288P |
NMPA Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
国药准字S10960017 | 注射剂 | N/A | 50IU/ml.2ml/支 | Biologics | Approved | 2021/06/04 | Domestic | ||
国药准字S10960016 | 注射剂 | N/A | 50IU/ml.1ml/支 | Biologics | Approved | 2021/06/04 | Domestic | ||
国药准字S10960018 | 注射剂 | N/A | 20IU/ml.1ml/支 | Biologics | Approved | 2020/10/30 | Domestic |
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Reg. Date |
|---|
No PPB products found
No PPB products found for this drug
TGA Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|---|---|---|---|---|
28624 | Active | 1991/11/04 | Tuberculin PPD |