Maa: Kanada
Kieli: englanti
Lähde: Health Canada
LOPERAMIDE HYDROCHLORIDE
MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
A07DA03
LOPERAMIDE
2MG
TABLET (ORALLY DISINTEGRATING)
LOPERAMIDE HYDROCHLORIDE 2MG
ORAL
10/20
OTC
ANTIDIARRHEA AGENTS
Active ingredient group (AIG) number: 0111332001; AHFS:
APPROVED
1998-06-01
_Product Monograph Master Template _ _Template Date: September 2020 _ _IMODIUM_ ® _Quick Dissolve, Loperamide Hydrochloride Tablets _ _IMODIUM_ ® _Calming Liquid, Loperamide Hydrochloride Oral Solution _ _IMODIUM_ ® _ LIQUI-GELS_ ® _, Loperamide Hydrochloride Capsules _ _Page 1 of 40_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION IMODIUM ® QUICK DISSOLVE Loperamide Hydrochloride Tablets Tablet (Orally Disintegrating), 2 mg, Oral McNeil Std and IMODIUM ® CALMING LIQUID Loperamide Hydrochloride Oral Solution Solution, 2 mg / 15 mL, Oral McNeil Std and IMODIUM ® LIQUI-GELS ® Loperamide Hydrochloride Capsules, Capsule, 2 mg, Oral McNeil Std Antidiarrheal agent McNeil Consumer Healthcare, Division of Johnson & Johnson Inc. 88 McNabb Street Markham, Ontario L3R 5L2 Date of Initial Authorization: IMODIUM ® Quick Dissolve: January 15, 1997 IMODIUM ® Calming Liquid: February 07, 2007 IMODIUM ® LIQUI-GELS ® : November 10, 2011 Date of Revision: December 2, 2022 Submission Control Number: 265788 LIQUI-GELS ® is a registered trademark of Catalent Pharma Solutions, Inc., used under license _ _ _Product Monograph Master Template _ _Template Date: September 2020 _ _IMODIUM_ ® _Quick Dissolve, Loperamide Hydrochloride Tablets _ _IMODIUM_ ® _Calming Liquid, Loperamide Hydrochloride Oral Solution _ _IMODIUM_ ® _ LIQUI-GELS_ ® _, Loperamide Hydrochloride Capsules _ _Page 2 of 40_ RECENT MAJOR LABEL CHANGES Section 4: Dosage and Administration – Addition of drug withdrawal syndrome Section 5: Overdosage – Addition of drug withdrawal syndrome Section 7: Warnings and Precautions – Addition of drug withdrawal syndrome Section 14: Clinical Trials – Addition of drug withdrawal syndrome 06/2022 06/2022 06/2022 06/2022 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 ................................................... Lue koko asiakirja