Overview
Pancrelipase, in general, is composed of a mixture of pancreatic enzymes which include amylases, lipases, and proteases. These enzymes are extracted from porcine pancreatic glands. The pancrelipase mixture was developed by Ortho-McNeil-Janssen Pharmaceuticals, Inc and FDA approved on April 12, 2010. For further information on the components of this mixture please visit Pancrelipase amylase, Pancrelipase protease and Pancrelipase lipase.
Indication
The use of pancrelipase amylase is part of the pancreatic enzyme replacement therapy. This therapy is indicated for the treatment of pancreatic insufficiency attributed to cystic fibrosis, chronic pancreatitis or any other medically defined pancreatic disease that might require it. Pancreatic diseases are associated with the deterioration of pancreatic parenchyma and of the dual physiological functions of the pancreas. Once established, pancreatic insufficiency results in malnutrition, weight loss, and steatorrhea.
Associated Conditions
- Aerophagy
- Deficiency Digestive enzymes
- Diarrhea
- Dyspepsia
- Exocrine Pancreatic Insufficiency
- Flatulence
- Gastrointestinal Discomfort
- Pancreatic Insufficiency
- Post Operative Gas
- Pre-operative Gas
- Fat malabsorption
- Meteorism
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/06/27 | Phase 4 | Recruiting | |||
2023/11/07 | Phase 4 | Recruiting | |||
2023/10/25 | Phase 4 | Recruiting | |||
2022/03/04 | Early Phase 1 | Completed | |||
2022/03/02 | Not Applicable | UNKNOWN | |||
2021/10/06 | Phase 4 | Completed | |||
2021/07/02 | N/A | Completed | |||
2020/03/19 | Phase 4 | Withdrawn | |||
2019/09/23 | Phase 2 | Active, not recruiting | Andrew Hendifar, MD | ||
2019/08/15 | Not Applicable | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Pancreatin Enteric-coated Tablets | 国药准字H51020255 | 化学药品 | 片剂(肠溶片) | 6/14/2024 | |
| Pancreatin Enteric-coated Tablets | 国药准字H41023837 | 化学药品 | 片剂 | 8/14/2020 | |
| Pancreatin Enteric-coated Tablets | 国药准字H23021389 | 化学药品 | 片剂 | 8/6/2020 | |
| Pancreatin Enteric-coated Tablets | 国药准字H21021500 | 化学药品 | 片剂 | 6/4/2020 | |
| Pancreatin Enteric-coated Tablets | 国药准字H45020372 | 化学药品 | 片剂 | 8/11/2020 | |
| Pancreatin Enteric-coated Tablets | 国药准字H51020254 | 化学药品 | 片剂(肠溶片) | 6/14/2024 | |
| Pancreatin Enteric-coated Tablets | 国药准字H37022180 | 化学药品 | 片剂 | 1/15/2021 | |
| Pancreatin Enteric-coated Tablets | 国药准字H50020880 | 化学药品 | 片剂 | 9/28/2020 | |
| Pancreatin Enteric-coated Tablets | 国药准字H42022480 | 化学药品 | 片剂(肠溶衣) | 5/19/2020 | |
| Pancreatin Enteric-coated Tablets | 国药准字H20056795 | 化学药品 | 片剂 | 9/22/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ENZYME | 16589 | Medicine | A | 9/20/1991 | |
| Orthoplex D.E.F. Tablets | 19973 | Medicine | A | 10/3/1991 | |
| EAGLE DIGESTAID tablet film-coated bottle | 15464 | Medicine | A | 9/27/1991 |
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