Overview
Tilactase is a beta-D-galactosidase obtained from Aspergillus oryzae. It is produced as a chewable tablet that has to be taken before the consumption of a lactose-containing meal. The beta-D-galactosidase us a large monomeric multi-domain enzyme of 985 residues that presents a catalytic (alpha/beta)8-barrel domain. It is considered by the WHO as part of the International Nonpropietary Names for Pharmaceutical Substances.
Indication
Tilactase is indicated for the symptomatic treatment of lactose intolerance in infants and older patients requiring a parenteral nutrition or fluid diet. Lactose intolerance occurs when there is an existence of an inability to break down lactose which is commonly found in dairy products. This inability occurs when the lactase levels are reduced and thus there is no via to digest and break down the lactose. The undigested lactose moves into the large intestine where normal flora bacteria can interact with it and cause bloating, gas and diarrhea.
Associated Conditions
- Lactose Intolerance
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2010/06/16 | Phase 3 | Completed | Eurofarma Laboratorios S.A. | ||
2010/06/16 | Phase 3 | Completed | Eurofarma Laboratorios S.A. |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Digestive Zyme | 328366 | Interclinical Laboratories Pty Ltd | Medicine | A | 1/8/2020 |
| NutriVital Professional Digestive Enzyme Balance | 375622 | Medicine | A | 9/30/2021 | |
| Bloating Relief | 486010 | Medicine | A | 4/14/2025 | |
| Eagle Vegie Digestaid | 330721 | Medicine | A | 3/4/2020 | |
| Henry Blooms Complete Digestion | 369253 | Medicine | A | 6/15/2021 | |
| Executive Digestive | 351741 | Medicine | A | 12/15/2020 | |
| Bioglan Platinum Digest Eze | 423692 | Medicine | A | 10/3/2023 | |
| PM Essentials | 342492 | Regulatory Services Australia | Medicine | A | 8/27/2020 |
| Nourex Professional Digestive Enzymes | 427214 | Medicine | A | 11/1/2023 | |
| SpringLeaf Digestive Enzyme Max | 447318 | Medicine | A | 5/1/2024 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| THERAPY FORMULAS MULTI-ENZYME FORMULA-CAP | general nutrition canada inc. | 02216736 | Capsule - Oral | 50 MG | 10/15/2001 |
| LACTASE ENZYME | holista health (canada) inc. | 02156512 | Capsule - Oral | 3000 UNIT | 5/8/2001 |
| SUPER MILK DIGESTANT | malabar formulas | 00603902 | Tablet - Oral | 50 MG / TAB | 12/31/1984 |
| MILK AID | swiss herbal remedies ltd. | 02243600 | Tablet - Oral | 3000 UNIT | 2/28/2001 |
| MEALZYME | regime industries ltd. | 02242743 | Capsule - Oral | 125 UNIT | 12/19/2001 |
| ENZYME FORMULA DIGESTION AID | rx vitamins inc. | 02239302 | Capsule - Oral | 25 MG | 3/1/2004 |
| NU-ZYMES | media power, inc. | 02246909 | Capsule - Oral | 1000 UNIT | 11/23/2002 |
| LACTAID TAB 3300UNIT | mcneil consumer healthcare division of johnson & johnson inc | 01936859 | Tablet - Oral | 3300 UNIT | 12/31/1992 |
| LACTASE 3400 FCC UNITS CAP | attogram corp | 02039737 | Capsule - Oral | 3400 UNIT / CAP | 12/31/1994 |
| DIGESTION FORMULA - CAP | prevail corporation | 02184885 | Capsule - Oral | 30 MG | 4/1/1999 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.