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:

Marketed

Current status date:

2024-02-14

Original market date: See footnote 1

2019-11-20

Product name:

BAQSIMI

Description:

SINGLE-DOSE DEVICE

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:

02492415

Product Monograph/Veterinary Labelling:

Date: 2024-02-14 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

AMPHASTAR PHARMACEUTICALS, INC.
11570 Sixth Street
Rancho Cucamonga
California
United States 91730

Class:

Human

Dosage form(s):

Powder

Route(s) of administration:

Nasal

Number of active ingredient(s):

1

Schedule(s):

Ethical

 

American Hospital Formulary Service (AHFS): See footnote 3

68:22.12 

Anatomical Therapeutic Chemical (ATC): See footnote 4

H04AA01 GLUCAGON

Active ingredient group (AIG) number:See footnote5

0101772002

List of active ingredient(s)
Active ingredient(s) Strength
GLUCAGON 3 MG / CONTAINER

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

Version 4.0.2
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