Flexicam

Withdrawn

This medicine's authorisation has been withdrawn

meloxicam

Overview

The marketing authorisation for Flexicam has been withdrawn at the request of the marketing authorisation holder.

Flexicam : EPAR - Summary for the public

Product information

Flexicam : EPAR - Product Information

Flexicam : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Flexicam
• Active substance:
  meloxicam
• International non-proprietary name (INN) or common name:
  meloxicam
• Species:
  • Dogs
  • Cats
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QM01AC06

Pharmacotherapeutic group

Anti-inflammatory and anti-rheumatic products

Therapeutic indication

Oral suspension:

Dogs:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.

Solution for injection:

Dogs:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.
Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats:
Reduction of postoperative pain after ovariohysterectomy and minor soft tissue surgery

Authorisation details

• EMA product number:
  EMEA/V/C/000102
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Dechra Veterinary Products A/S

  Mekuvej 9; 7171 Uldum; Denmark

• Marketing authorisation issued:
  10/04/2006
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

Flexicam : EPAR - Procedural steps taken and scientific information after authorisation

Flexicam : EPAR - Scientific conclusions and grounds for the suspension of the marketing authorisation of the 1.5 mg/ml presentation

Committee for medicinal products for veterinary use post-authoriastion summary of opinion: Flexicam: International Non-proprietary Name (INN): Meloxicam

Adopted Reference Number: EMEA/CVMP/512816/2008

Initial marketing authorisation documents

Flexicam : EPAR - Scientific Discussion

Flexicam : EPAR - Procedural steps taken before authorisation