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Date: 2016-12-19

Type of information: Granting of a Market Authorisation in the EU

Product name: Orthovisc®-T

Compound: sodium hyaluronate for peritendinous injection

Therapeutic area: Rheumatic diseases - Inflammatory diseases

Action mechanism:

viscosupplement. Orthovisc®-T consists of a biocompatible, non-animal-derived and non-inflammatory formulation of hyaluronic acid similar to those found in the company's best-selling viscosupplements, Orthovisc® and Monovisc®.

Company: Anika Therapeutics (USA – MA)

Disease:

treatment of pain associated with chronic lateral epicondylosis

Latest news:

* On December 19, 2016, Anika Therapeutics announced that it received CE Mark approval for Orthovisc®-T (sodium hyaluronate for peritendinous injection), a treatment indicated to relieve pain and restore function in tendons affected by chronic lateral epicondylosis. Orthovisc®-T is designed to provide lubrication to the site of the damaged tendons to promote tendon gliding and to provide an environment to support tendon repair. The compound is administered via injection into the site of injury to relieve pain and restore function of tendons damaged by chronic injury and overuse, as often seen in tennis elbow.  

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization: 2016-12-19

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes