国: カナダ
言語: 英語
ソース: Health Canada
CALCIPOTRIOL
LEO PHARMA INC
D05AX02
CALCIPOTRIOL
50MCG
CREAM
CALCIPOTRIOL 50MCG
TOPICAL
60G
Prescription
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Active ingredient group (AIG) number: 0123661001; AHFS:
CANCELLED POST MARKET
2016-03-11
PRODUCT MONOGRAPH PR DOVONEX® CALCIPOTRIOL CREAM AND OINTMENT, 50 MCG/G SCALP SOLUTION, 50 MCG/ML TOPICAL NON-STEROIDAL ANTIPSORIATIC AGENT LEO PHARMA INC. THORNHILL, ONTARIO L3T 7W8 WWW.LEO-PHARMA.COM/CANADA Date of Preparation: October 27, 1992 Date of Revision: OCTOBER 9, 2007 Submission Control No: 109621 ®Registered trademark of LEO Pharma A/S used under license by LEO Pharma Inc., Thornhill, ON _ _ _DOVONEX® (calcipotriol) Product Monograph, version 2.0 _ _Page 2 of 41_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS..................................................................................4 ADVERSE REACTIONS....................................................................................................6 DRUG INTERACTIONS ....................................................................................................7 DOSAGE AND ADMINISTRATION................................................................................7 OVERDOSAGE ..................................................................................................................9 ACTION AND CLINICAL PHARMACOLOGY ..............................................................9 STORAGE AND STABILITY..........................................................................................11 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................12 PART II: SCIENTIFIC INFORMATION ...............................................................................13 PHARMACEUTICAL INFORMATION..........................................................................13 CLINICAL TRIALS....... 完全なドキュメントを読む