🇺🇸 PERTZYE in United States

FDA authorised PERTZYE on 17 May 2012 · 403 US adverse-event reports

Marketing authorisations

FDA — authorised 17 May 2012

  • Application: BLA022175
  • Marketing authorisation holder: DIGESTIVE CARE INC
  • Local brand name: PERTZYE
  • Indication: CAPSULE, DELAYED RELEASE — ORAL
  • Status: approved

Read official source →

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. Infective Pulmonary Exacerbation Of Cystic Fibrosis — 92 reports (22.83%)
  2. Cystic Fibrosis — 53 reports (13.15%)
  3. Hospitalisation — 48 reports (11.91%)
  4. Pneumonia — 44 reports (10.92%)
  5. Cough — 41 reports (10.17%)
  6. Headache — 28 reports (6.95%)
  7. Off Label Use — 27 reports (6.7%)
  8. Infection — 25 reports (6.2%)
  9. Diarrhoea — 23 reports (5.71%)
  10. Constipation — 22 reports (5.46%)

Source database →

PERTZYE 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 PERTZYE approved in United States?

Yes. FDA authorised it on 17 May 2012; FDA has authorised it.

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

DIGESTIVE CARE INC holds the US marketing authorisation.