This brand name is authorized in United States. It is also authorized in Australia, Brazil, Canada, Cyprus, Ecuador, Finland, France, Hong Kong SAR China, Ireland, Israel, Malta, Mexico, Netherlands, New Zealand, Nigeria, Singapore, South Africa, Tunisia, UK.
The drug CREON contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
8MYC33932O - PANCRELIPASE LIPASE
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Pancreatin when reaching the small intestine disintegrates (at pH>5.5) to release enzymes with lipolytic, amylolytic and proteolytic activity to ensure the digestion of fats, starches and proteins. The products of pancreatic digestion are then either absorbed directly, or following further hydrolysis by intestinal enzymes. |
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2
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UNII
YOJ58O116E - PANCRELIPASE AMYLASE
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Pancreatin when reaching the small intestine disintegrates (at pH>5.5) to release enzymes with lipolytic, amylolytic and proteolytic activity to ensure the digestion of fats, starches and proteins. The products of pancreatic digestion are then either absorbed directly, or following further hydrolysis by intestinal enzymes. |
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3
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UNII
3560D81V50 - PANCRELIPASE PROTEASE
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Pancreatin when reaching the small intestine disintegrates (at pH>5.5) to release enzymes with lipolytic, amylolytic and proteolytic activity to ensure the digestion of fats, starches and proteins. The products of pancreatic digestion are then either absorbed directly, or following further hydrolysis by intestinal enzymes. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| CREON Capsule containing gastro-resistant granules | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| A09AA02 | Multienzymes (lipase, protease etc.) | A Alimentary tract and metabolism → A09 Digestives, incl. enzymes → A09A Digestives, incl. enzymes → A09AA Diastase |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| AU | Pharmaceutical Benefits Scheme | 12578B, 12595X, 5453B, 5454C, 8020D, 8021E, 9226N, 9227P, 9412J, 9413K |
| BR | Câmara de Regulação do Mercado de Medicamentos | 500214010030914, 500214010031014, 500218090042607, 500218090042707, 500218090042807 |
| CA | Health Products and Food Branch | 01985205, 02200104, 02445158 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 1678-MEE-0116, 1688-MEE-0116 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 073224, 073805, 185494 |
| FR | Base de données publique des médicaments | 61529057, 61969156, 62726958, 65294763 |
| GB | Medicines & Healthcare Products Regulatory Agency | 138573, 142116, 161542, 161544, 178988, 182277, 195422, 27906, 27912, 374023, 80624 |
| HK | Department of Health Drug Office | 48670, 61240 |
| IE | Health Products Regulatory Authority | 18907, 18938, 18941, 18992, 19089, 19117, 19159, 19204, 19255 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 3569, 8189 |
| MT | Medicines Authority | MA1507/00201, MA1507/00202, MA1507/00203, MA1507/00204 |
| MX | Comisión Federal para la Protección contra Riesgos Sanitarios | 035M86 |
| NG | Registered Drug Product Database | C4-1547, C4-1548 |
| NL | Z-Index G-Standaard, PRK | 100331, 100358, 199366, 204056, 77135 |
| NZ | Medicines and Medical Devices Safety Authority | 14930, 20517, 20518, 5704, 8520 |
| SG | Health Sciences Authority | 13945P |
| TN | Direction de la Pharmacie et du Médicament | 5873081, 5873082 |
| US | FDA, National Drug Code | 0032-1203, 0032-1206, 0032-1212, 0032-1224, 0032-3016 |
| ZA | Health Products Regulatory Authority | 28/11.1/0645, 33/11.1/0340, 42/11.1/0068, W/11.1/372 |
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