País: Canadá
Língua: inglês
Origem: Health Canada
IXAZOMIB (IXAZOMIB CITRATE)
TAKEDA CANADA INC
L01XG03
IXAZOMIB
3MG
CAPSULE
IXAZOMIB (IXAZOMIB CITRATE) 3MG
ORAL
3
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0158410002; AHFS:
APPROVED
2016-08-04
_NINLARO (as ixazomib citrate) capsules _ _Page 1 of 42_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR NINLARO ® Ixazomib capsules Capsules, 4 mg, 3 mg and 2.3 mg ixazomib (as ixazomib citrate), Oral Antineoplastic Agent Takeda Canada Inc. 22 Adelaide Street West, Suite 3800 Toronto Ontario M5H 4E3 Date of Initial Authorization: Aug 3, 2016 Date of Revision: Feb 02, 2024 Submission Control Number: 279731 NINLARO® and the NINLARO Logo® are registered trademarks of Millennium Pharmaceuticals, Inc. TAKEDA™ and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited, used under license. _NINLARO (as ixazomib citrate) capsules _ _Page 2 of 42_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Skin 02/2024 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 1.2 Geriatrics ................................................................................................................. 4 2. CONTRAINDICATIONS ................................................................................................... 4 3. SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................. 4 4 DOSAGE AND ADMINISTRATION .................................................................................. 5 4.1 Dosing Considerations ........................................... Leia o documento completo