국가: 캐나다
언어: 영어
출처: Health Canada
ZOLMITRIPTAN
JUBILANT GENERICS LIMITED
N02CC03
ZOLMITRIPTAN
2.5MG
TABLET (ORALLY DISINTEGRATING)
ZOLMITRIPTAN 2.5MG
ORAL
6
Prescription
SELECTIVE SEROTONIN AGONISTS
Active ingredient group (AIG) number: 0134381001; AHFS:
APPROVED
2014-01-20
_ZOLMITRIPTAN-ODT _ _Page 1 of 31 _ PRODUCT MONOGRAPH PR ZOLMITRIPTAN-ODT Zolmitriptan Orally Disintegrating Tablets 2.5 mg 5-HT 1 Receptor Agonist MIGRAINE THERAPY SPONSOR: DATE OF REVISION: Jubilant Generics Limited April 1, 2020 1A- Sector 16A, Institutional Area, Noida, Uttar Pradesh, India, 201301 DISTRIBUTOR: Pharmapar Inc., 1565 Boul. Lionel- Boulet, Varennes QC J3X 1P7 SUBMISSION CONTROL NO.: 237423 _ZOLMITRIPTAN-ODT _ _Page 2 of 31 _ 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.................................................................................................. 10 DRUG INTERACTIONS.................................................................................................. 15 DOSAGE AND ADMINISTRATION.............................................................................. 17 OVERDOSAGE................................................................................................................. 18 ACTION AND CLINICAL PHARMACOLOGY............................................................. 18 STORAGE AND STABILITY.......................................................................................... 20 DOSAGE FORMS, COMPOSITION AND PACKAGING............................................. 20 PART II: SCIENTIFIC INFORMATION......................................................................... 21 PHARMACEUTICAL INFORMATION.......................................................................... 21 CLINICAL TRIALS.............................................................. 전체 문서 읽기