🇺🇸 PERSERIS in United States

FDA authorised PERSERIS on 27 July 2018 · 296 US adverse-event reports

Marketing authorisations

FDA — authorised 27 July 2018

  • Application: NDA210655
  • Marketing authorisation holder: INDIVIOR
  • Status: supplemented

FDA

  • Status: approved

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. Injection Site Pain — 78 reports (26.35%)
  2. Product Administered At Inappropriate Site — 32 reports (10.81%)
  3. Off Label Use — 31 reports (10.47%)
  4. Schizophrenia — 27 reports (9.12%)
  5. Incorrect Route Of Product Administration — 26 reports (8.78%)
  6. Product Preparation Error — 25 reports (8.45%)
  7. Therapeutic Response Shortened — 23 reports (7.77%)
  8. Injection Site Erythema — 19 reports (6.42%)
  9. Weight Increased — 18 reports (6.08%)
  10. Drug Effect Less Than Expected — 17 reports (5.74%)

Source database →

PERSERIS in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is PERSERIS approved in United States?

Yes. FDA authorised it on 27 July 2018; FDA has authorised it.

Who is the marketing authorisation holder for PERSERIS in United States?

INDIVIOR holds the US marketing authorisation.