NALCROM CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CROMOLYN SODIUM

Available from:

SANOFI-AVENTIS CANADA INC

ATC code:

A07EB01

INN (International Name):

CROMOGLICIC ACID

Dosage:

100MG

Pharmaceutical form:

CAPSULE

Composition:

CROMOLYN SODIUM 100MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MAST-CELL STABILIZERS

Product summary:

Active ingredient group (AIG) number: 0108810001; AHFS:

Authorization status:

APPROVED

Authorization date:

2000-11-01

Summary of Product characteristics

_NALCROM Sodium Cromoglicate Capsules _
_Page 1 of 17 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NALCROM®
Sodium Cromoglicate Capsules
Capsules, 100 mg, Oral
Oral Anti-Allergic Agent
ATC Code: A07EB01
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval, Quebec H7V 0A3
www.sanofi.ca
Date of Initial Authorization:
JAN 31, 1980
Date of Revision:
JAN 5, 2022
Submission Control Number: 253935
_ _
_NALCROM Sodium _
_Cromoglicate_
_ Capsules _
_Page 2 of 17_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
12/2021
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
12/2021
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................4
4.2
Recommended Dose and Dosage
Adjustment.......................................................4
4.4
Administration.....................................................................................................5
4.5
Missed Dose
........................................................................................................5
5
OVERDOSAGE
............................................................................