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PRODUCT MONOGRAPH INCLUDING PATIENT …
FIBRISTAL Ulipristal Acetate, 5 mg tablets Page 1 of 55 PRODUCT MONOGRAPH INCLUDING PATIENT medication information PrFIBRISTAL ulipristal acetate tablet, 5 mg Selective Progesterone Receptor Modulator (SPRM) Allergan Pharma Co. 85 Enterprise Blvd., Suite 500 Markham, Ontario CANADA L6G 0B5 Date of Revision: January 10, 2018 Submission Control No: 209518 FIBRISTAL is a trade-mark of Allergan, Inc. under license by Allergan Pharma Co. FIBRISTAL Ulipristal Acetate, 5 mg tablets Page 2 of 55 Table of Contents PART I: HEALTH PROFESSIONAL information ..3 SUMMARY PRODUCT information ..3 INDICATIONS AND CLINICAL USE ..3 CONTRAINDICATIONS ..3 WARNINGS AND PRECAUTIONS ..4 ADVERSE REACTIONS ..6 DRUG INTERACTIONS ..14 DOSAGE AND ADMINISTRATION ..16 OVERDOSAGE ..16 ACTION AND CLINICAL PHARMACOLOGY ..16 STORAGE AND STABILITY ..18 SPECIAL HANDLING INSTRUCTIONS ..19 DOSAGE FORMS, COMPOSITION AND PACKAGING.
FIBRISTAL® Ulipristal Acetate, 5 mg tablets Page 1 of 55 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrFIBRISTAL® ulipristal …
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