Product information
From Health Canada
The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.
Current status:
Marketed
Current status date:
2023-03-15
Original market date: See footnote 1
2023-03-15
Product name:
REDDY-POMALIDOMIDE
DIN:
02504103
Product Monograph/Veterinary Labelling:
Date:
2022-12-07
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
DR REDDY'S LABORATORIES LTD
Survey Nos 42,45,46,54 Bachupally, Quthbullapur
Hyderabad
Telangana
India
500090
Class:
Human
Dosage form(s):
Capsule
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
10:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L04AX06 POMALIDOMIDE
Active ingredient group (AIG) number:See footnote5
0155290003
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| POMALIDOMIDE | 3 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Controlled Distribution Program |
| Healthcare Professional Education |
| Patient Consent |
| Patient Education |