CREON MINIMICROSPHERES 35 CAPSULE (DELAYED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LIPASE; AMYLASE; PROTEASE

Available from:

BGP PHARMA ULC

ATC code:

A09AA02

INN (International Name):

MULTIENZYMES (LIPASE, PROTEASE ETC)

Dosage:

35000UNIT; 35700UNIT; 2240UNIT

Pharmaceutical form:

CAPSULE (DELAYED RELEASE)

Composition:

LIPASE 35000UNIT; AMYLASE 35700UNIT; PROTEASE 2240UNIT

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

DIGESTANTS

Product summary:

Active ingredient group (AIG) number: 0302964045; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-12-03

Summary of Product characteristics

_CREON MINIMICROSPHERES_
®
_ Product Monograph _
_Page 1 of 21 _
_Date of Revision: August 26, 2019 and Control No. 226040; Date of
Approval: December 5, 2019 _
PRODUCT MONOGRAPH
PR
CREON
MINIMICROSPHERES
®
lipase/amylase/protease
PR
CREON
MINIMICROSPHERES
® MICRO
lipase/amylase/protease
Granules (5,000 Ph. Eur. units / 5,100 Ph. Eur. units / 320 Ph. Eur.
units)
PR
CREON MINIMICROSPHERES
® 10
lipase/amylase/protease
Capsules (10,000 Ph. Eur. units / 11,200 Ph. Eur. units / 730 Ph. Eur.
units)
PR CREON MINIMICROSPHERES
® 20
lipase/amylase/protease
Capsules (20,000 Ph. Eur. units / 22,400 Ph. Eur. units / 1,460 Ph.
Eur. units)
_ _
PR
CREON MINIMICROSPHERES
® 25
lipase/amylase/protease
Capsules (25,000 Ph. Eur. units / 25,500 Ph. Eur. units / 1,600 Ph.
Eur. units)
_ _
PR CREON MINIMICROSPHERES
® 35
lipase/amylase/protease_ _
Capsules (35,000 Ph. Eur. units / 35,700 Ph. Eur. units / 2,240 Ph.
Eur. units)_ _
_ _
Pancreatic Enzymes
This product is of porcine origin_ _
® Registered trademark BGP Products Operations GmbH; Licensed use by
BGP Pharma ULC, Mylan company.
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Submission Control No: 275798
Date of Approval: August 21, 2023
_CREON MINIMICROSPHERES_
®
_ Product Monograph _
_Page 2 of 21 _
_Date of Revision: August 26, 2019 and Control No. 226040; Date of
Approval: December 5, 2019 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................7
DR