CREON MINIMICROSPHERES 25 25000 UNIT — DIN 01985205
PROTEASE : 1600 UNIT AMYLASE : 25500 UNIT LIPASE : 25000 UNIT · BGP PHARMA ULC · CAPSULE (DELAYED RELEASE) · wholesale supply in Canada
Health Canada status: MARKETED
What is CREON MINIMICROSPHERES 25?
CREON MINIMICROSPHERES 25 25000 UNIT contains PROTEASE : 1600 UNIT AMYLASE : 25500 UNIT LIPASE : 25000 UNIT. It is listed in the Health Canada Drug Product Database under DIN 01985205, held by BGP PHARMA ULC, supplied as CAPSULE (DELAYED RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 20-Nov-2015. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is CREON MINIMICROSPHERES 25 used for?
CREON MINIMICROSPHERES® (pancreatin) is indicated in pediatric and adult patients for: • treatment of pancreatic exocrine insufficiency (PEI) attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic disease that might require pancreatic enzyme therapy including, but not limited to: cystic fibrosis, chronic pancreatitis, pancreatic surgery, gastrectomy, pancreatic cancer, gastrointestinal bypass surgery (e.g. Billroth II gastroenterostomy), ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm), Shwachman-Diamond Syndrome, status after an attack of acute pancreatitis and initiation of enteral or oral feeding.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Multienzymes (Lipase, Protease Etc) in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
36 holders have a Canadian DIN containing Multienzymes (Lipase, Protease Etc), across 65 DINs, of which 14 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| VIVUS LLC. | 5 | 5 | PANCREASE MT 10, PANCREASE MT 16, PANCREASE MT 2, PANCREASE MT 20, PANCREASE MT 4 | Sourceable in Canada |
| BGP PHARMA ULC | 6 | 4 | CREON MINIMICROSPHERES 10, CREON MINIMICROSPHERES 20, CREON MINIMICROSPHERES 25, CREON MINIMICROSPHERES 35, CREON MINIMICROSPHERES 6, +1 more | Sourceable in Canada |
| ORGANON CANADA INC. | 3 | 3 | COTAZYM, COTAZYM ECS 20, COTAZYM ECS 8 | Sourceable in Canada |
| NESTLE ENTERPRISES S.A. | 2 | 2 | VIOKACE | Sourceable in Canada |
| PAINES AND BYRNE LTD. | 5 | 0 | PANCREX GRANULES, PANCREX V CAPSULES, PANCREX V FORTE TABLETS 1GM/TAB, PANCREX V POWDER, PANCREX V TAB 0.33GM | No marketed DIN |
| APTALIS PHARMA CANADA ULC | 4 | 0 | ULTRASE, ULTRESA | No marketed DIN |
| NU-LIFE NUTRITION LTD. | 3 | 0 | BROMELAIN 500 + PAPAIN AND GALACTOSIDASE, PAPAYA ZYME TAB NU LIFE, VEGE-DIGEST DIGESTIVE AID | No marketed DIN |
| AXCAN PHARMA INC | 2 | 0 | DIGESS 8000 - CAP, VIOKASE POWDER | No marketed DIN |
| AYERST LABORATORIES | 2 | 0 | VIOKASE PWR, VIOKASE TAB | No marketed DIN |
| GAHLER ENTERPRISES LTD. | 2 | 0 | CHEWABLE ENZYMES TABLETS, PANCREATINE ENZYMES | No marketed DIN |
| JAMIESON LABORATORIES LTD | 2 | 0 | PANCREATIN TAB 400MG, SUPER PAYA JAY TAB | No marketed DIN |
| METAGENICS, INC. | 2 | 0 | BIO-ZYME TAB 50MG, METAZYME CAP | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 25000 UNIT |
|---|---|
| Dosage form | CAPSULE (DELAYED RELEASE) |
| Route | ORAL |
| Pack configuration (monograph) | CREON MINIMICROSPHERES® MICRO: glass bottles of 20 grams. CREON MINIMICROSPHERES® 10, 20, 25, 35: HDPE bottles of 100 capsules. |
| Storage | Store CREON MINIMICROSPHERES® at temperatures not exceeding 25 °C in a tightly-closed container to protect from moisture. Once opened, store at temperatures not exceeding 25 °C, keep the container tightly-closed to protect from moisture and use within 6 months. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Multienzymes (Lipase, Protease Etc) |
|---|---|
| ATC code | A09AA02 |
| AHFS class | 56:16.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 01985205 |
|---|---|
| DIN (unpadded, as printed on some documents) | 1985205 |
| Brand name | CREON MINIMICROSPHERES 25 |
| Generic / active ingredient | PROTEASE : 1600 UNIT AMYLASE : 25500 UNIT LIPASE : 25000 UNIT |
| Market authorization holder | BGP PHARMA ULC |
| Health Canada schedule | Prescription |
| ATC code | A09AA02 |
| ATC anatomical main group | A — Alimentary tract and metabolism |
| ATC therapeutic subgroup | A09AA |
| Current status | MARKETED |
| Status date | 20-Nov-2015 |
| Original market date | 1992-12-31 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Individualized based on severity of PEI and fat intake. Infants: 2,000-5,000 units/feeding. Adults: 25,000-80,000 units/meal. Take during or immediately after meals. Do not crush or chew.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to porcine protein, pancreatic enzymes, or any ingredient in the formulation.
Warnings and precautions
Associated with fibrosing colonopathy at high doses in CF patients. Not unit-for-unit substitutable with other products. Ensure adequate hydration. Potential theoretical viral exposure risk.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
14 of 65 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| COTAZYM | 35000 UNIT | CAPSULE (IMMEDIATE RELEASE) | ORGANON CANADA INC. | MARKETED | 00263818 |
| COTAZYM ECS 20 | 25000 UNIT | CAPSULE (DELAYED RELEASE) | ORGANON CANADA INC. | MARKETED | 00821373 |
| COTAZYM ECS 8 | 10800 UNIT | CAPSULE (DELAYED RELEASE) | ORGANON CANADA INC. | MARKETED | 00502790 |
| CREON MINIMICROSPHERES 10 | 10000 UNIT | CAPSULE (DELAYED RELEASE) | BGP PHARMA ULC | MARKETED | 02200104 |
| CREON MINIMICROSPHERES 35 | 35700 UNIT | CAPSULE (DELAYED RELEASE) | BGP PHARMA ULC | MARKETED | 02494639 |
| CREON MINIMICROSPHERES MICRO | 5000 UNIT / 100 MG | GRANULES FOR SUSPENSION, DELAYED RELEASE | BGP PHARMA ULC | MARKETED | 02445158 |
| PANCREASE MT 10 | 43750 UNIT | CAPSULE (DELAYED RELEASE) | VIVUS LLC. | MARKETED | 00789437 |
| PANCREASE MT 16 | 70000 UNIT | CAPSULE (DELAYED RELEASE) | VIVUS LLC. | MARKETED | 00789429 |
| PANCREASE MT 2 | 6200 UNIT | CAPSULE (DELAYED RELEASE) | VIVUS LLC. | MARKETED | 02503433 |
| PANCREASE MT 20 | 37000 UNIT | CAPSULE (DELAYED RELEASE) | VIVUS LLC. | MARKETED | 02503441 |
2 · Same class — other molecules in ATC A09AA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Multienzymes (Lipase, Protease Etc) | BIO-ZYME TAB 50MG · BROMELAIN 500 + PAPAIN AND GALACTOSIDASE · BROMELAIN AND PAPAIN TAB · CELL TECH ENZYMES - CAP · +57 more | 65 | 14 | Yes |
| Tilactase | DAIRY DIGESTIVE AID TAB 3000FCC LACTASE UNIT · DAIRY DIGESTIVE ULTRA STRENGTH SUPPLEMENT · EXTRA STRENGTH LACTAID TABLETS - 4500FCCLU · LACTACE CAP 3400UNIT · +7 more | 11 | 0 | Not in Canada |
| Enzyme Preparations | BEANO DROPS · BEANO DROPS 780UNITS/ML · BEANO TABLETS 150 GALUNITS/TAB · FORMULA C & E · +6 more | 10 | 0 | Not in Canada |
| Pepsin, Combinations | DIGEST EASE · PEPSOTOL | 2 | 0 | Not in Canada |
| Pepsin | DIGESTEX | 1 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC A09A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| A09AB | Betaine Hydrochloride · Betaine Hydrochloride, Combinations · Glutamic Acid Hydrochloride | 4 | 0 |
| A09AC | Enzyme And Acid Preparations, Combinations · Multienzymes And Acid Preparations · Pepsin And Acid Preparations | 23 | 0 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is CREON MINIMICROSPHERES 25 called?
Also recorded in Canada as: amylase 15000 UNT / lipase 3000 UNT / protease 9500 UNT Delayed Release Oral Capsule [Creon] (US), amylase 78300 UNT / lipase 20880 UNT / protease 78300 UNT Oral Tablet [Viokace] (US), amylase 39150 UNT / lipase 10440 UNT / protease 39150 UNT Oral Tablet [Viokace] (US), amylase 60500 UNT / lipase 16000 UNT / protease 57500 UNT Delayed Release Oral Capsule [Pertzye] (US), amylase 30250 UNT / lipase 8000 UNT / protease 28750 UNT Delayed Release Oral Capsule [Pertzye] (US), amylase 180000 UNT / lipase 36000 UNT / protease 114000 UNT Delayed Release Oral Capsule [Creon] (US), amylase 64000 UNT / lipase 9000 UNT / protease 57000 UNT Oral Tablet [PanaKare] (US), amylase 164 UNT/MG / lipase 25.5 UNT/MG / protease 139 UNT/MG Oral Powder [PanaKare] (US), amylase 64000 UNT / lipase 9000 UNT / protease 57000 UNT Oral Tablet [PancrePlus] (US), amylase 15125 UNT / lipase 4000 UNT / protease 14375 UNT Delayed Release Oral Capsule [Pertzye] (US), amylase 105000 UNT / lipase 25000 UNT / protease 79000 UNT Delayed Release Oral Capsule [Zenpep] (US), amylase 14000 UNT / lipase 3000 UNT / protease 10000 UNT Delayed Release Oral Capsule [Zenpep] (US), amylase 24000 UNT / lipase 5000 UNT / protease 17000 UNT Delayed Release Oral Capsule [Zenpep] (US), amylase 42000 UNT / lipase 10000 UNT / protease 32000 UNT Delayed Release Oral Capsule [Zenpep] (US), amylase 63000 UNT / lipase 15000 UNT / protease 47000 UNT Delayed Release Oral Capsule [Zenpep] (US).
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.