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PASIREOTIDE PAMOATE ›
Regulatory · United States
Marketing authorisations
FDA — authorised 15 December 2014
Application: NDA203255
Marketing authorisation holder: RECORDATI RARE
Local brand name: SIGNIFOR LAR KIT
Indication: FOR SUSPENSION — INTRAMUSCULAR
Status: approved
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FDA
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.
Window: 20 April 2025 – 20 April 2026
Total reports: 70
Most-reported reactions
Blood Pressure Increased — 8 reports (11.43%) Cough — 8 reports (11.43%) Drug Ineffective — 8 reports (11.43%) Nasopharyngitis — 8 reports (11.43%) Oropharyngeal Pain — 8 reports (11.43%) Anaemia — 6 reports (8.57%) Blood Glucose Increased — 6 reports (8.57%) Concomitant Disease Aggravated — 6 reports (8.57%) Diabetes Mellitus — 6 reports (8.57%) Diarrhoea — 6 reports (8.57%)
Source database →
PASIREOTIDE PAMOATE 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 PASIREOTIDE PAMOATE approved in United States?
Yes. FDA authorised it on 15 December 2014; FDA has authorised it.
Who is the marketing authorisation holder for PASIREOTIDE PAMOATE in United States?
RECORDATI RARE holds the US marketing authorisation.