8.11.2023

Monovisc® approved for extended Areas of Application in the EU

Monovisc® has now been approved in the EU for extended areas of application (hip, shoulder and ankle)!

The product Monovisc®, an injection for the treatment of joint pain that was recently approved for extended applications in the EU, in front of packaging on a white background.

Big news from Anika! Monovisc® has been officially approved in the EU for use not only in knees but also in hip, shoulder and ankle joints. This significant expansion is based on extensive clinical studies and is fantastic news for patients who can now benefit from Monovisc®'s proven pain relief in various joints.

The adjustments in the Instructions for use (IFU) may still take some time. However, the electronic user manual (eIFU) is updated and published faster than the paper version. The application of Monovisc for this indications is from now on in EU countries potential.

As soon as the Package insert is updated, it will read as follows:

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Monovisc is indicated as a viscoelastic supplement or a replacement for synovial fluid in human knee, hip, shoulder and ankle joints. Monovisc is well suited for treatment of the symptoms of mild to moderate osteoarthritis of the knee, hip, shoulder, and ankle joints for patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics. In clinical studies, Monovisc has been proven to have a duration of effect of at least 6 months and a second injection 6 months after the first injection was shown to be safe.

To the MONOVISC® product page