🇺🇸 Collagenase Clostridium Histolyticum-Aaes in United States

FDA authorised Collagenase Clostridium Histolyticum-Aaes on 6 July 2020 · 8 US adverse-event reports

Marketing authorisation

FDA — authorised 6 July 2020

  • Application: BLA761146
  • Marketing authorisation holder: ENDO GLOBAL AESTHETICS LTD
  • Local brand name: QWO
  • Indication: SOLUTION — SUBCUTANEOUS
  • Status: approved

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Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Anxiety — 1 report (12.5%)
  2. Contusion — 1 report (12.5%)
  3. Ill-Defined Disorder — 1 report (12.5%)
  4. Injection Site Bruising — 1 report (12.5%)
  5. Injection Site Discolouration — 1 report (12.5%)
  6. Pain — 1 report (12.5%)
  7. Skin Atrophy — 1 report (12.5%)
  8. Skin Discolouration — 1 report (12.5%)

Source database →

Frequently asked questions

Is Collagenase Clostridium Histolyticum-Aaes approved in United States?

Yes. FDA authorised it on 6 July 2020.

Who is the marketing authorisation holder for Collagenase Clostridium Histolyticum-Aaes in United States?

ENDO GLOBAL AESTHETICS LTD holds the US marketing authorisation.