Product information

From Health Canada

The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Cancelled Post Market

Current status date:

2018-06-14

Original market date: See footnote 1

2014-05-12

Lot number: See footnote 2

15089

Expiry date: See footnote 2

2018-05-31

Product name:

OCPHYL

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

DIN:

02413205

Product Monograph/Veterinary Labelling:

Date: 2014-05-22 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

PENDOPHARM DIVISION OF PHARMASCIENCE INC
100 6111 Royalmount Ave
Montreal
Quebec
Canada H4P 2T4

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous ,  Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

92:00.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

H01CB02 OCTREOTIDE

Active ingredient group (AIG) number:See footnote5

0121548009

List of active ingredient(s)
Active ingredient(s) See footnote8 Strength
OCTREOTIDE (OCTREOTIDE ACETATE) 100 MCG / ML
Version 4.0.3

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