Țară: Canada
Limbă: engleză
Sursă: Health Canada
ALITRETINOIN
GLAXOSMITHKLINE INC
D11AH04
ALITRETINOIN
30MG
CAPSULE
ALITRETINOIN 30MG
ORAL
30
Prescription
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Active ingredient group (AIG) number: 0137581003; AHFS:
CANCELLED POST MARKET
2023-07-14
_1343/521 TOCTINO _ _ _ _Page 1 of 43_ PRODUCT MONOGRAPH PR TOCTINO alitretinoin Soft capsule 10 mg and 30 mg Immunomodulator/Anti-inflammatory agent GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 Submission Control No. : 225922 Date of Revision: June 25, 2019 _©_ _ 2019 GSK group of companies or its licensor_ _Trademarks are owned by or licensed to the GSK group of companies. _ _1343/521 TOCTINO _ _ _ _Page 2 of 43_ _ _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION.................................................... 3 SUMMARY PRODUCT INFORMATION .................................................................. 3 INDICATIONS AND CLINICAL USE ....................................................................... 3 CONTRAINDICATIONS ......................................................................................... 4 WARNINGS AND PRECAUTIONS .......................................................................... 5 ADVERSE REACTIONS ....................................................................................... 13 DRUG INTERACTIONS ........................................................................................ 17 DOSAGE AND ADMINISTRATION ...................................................................... 19 OVERDOSAGE .................................................................................................... 20 ACTION AND CLINICAL PHARMACOLOGY ....................................................... 21 STORAGE AND STABILITY ................................................................................. 24 SPECIAL HANDLING INSTRUCTIONS ................................................................. 24 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................... 24 PART II: SCIENTIFIC INFORMATION....................................................................... 25 PHARMACEUTICAL INFORMATION ................................................................... 25 CLINICAL TRIALS ................................... Citiți documentul complet