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:

2023-08-04

Original market date: See footnote 1

2023-08-04

Product name:

CLEVIPREX

Description:

FOR IV INFUSION ONLY. 50ML & 100ML SINGLE USE VIALS. PRESERVATIVE FREE.

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DIN:

02366223

Product Monograph/Veterinary Labelling:

Date: 2022-06-22 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

CHIESI FARMACEUTICI S.P.A.
26/A Via Palermo
Parma
--
Italy 43122

Class:

Human

Dosage form(s):

Emulsion

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

24:28.08 

Anatomical Therapeutic Chemical (ATC): See footnote 4

C08CA16 CLEVIDIPINE

Active ingredient group (AIG) number:See footnote5

0152890001

List of active ingredient(s)
Active ingredient(s) Strength
CLEVIDIPINE 0.5 MG / ML
Version 4.0.2
Date modified: