Janssen Research & Development, LLC

Pre-Approval Access to Pimodivir for the Treatment of Patients With H7N9 Influenza A Infection

Official Title: 
Pimodivir (JNJ-63623872) Pre Approval Access_Single Patient Access (SPR) for Patients Diagnosed With H7N9 Influenza A Infection
Brief Summary: 
The purpose of this program is to provide pre-approval access to pimodivir for the treatment of a patient(s) with H7N9 influenza A infection. Pre-approval access pertains to provision for therapeutic use of an investigational product prior to its marketing authorization. Such access may be considered for eligible patients with serious/life-threatening diseases or conditions, where alternative treatments do not exist or have been exhausted.
EA Type
Individual Patients
H7N9 Subtype of Influenza A Virus

Drug: Pimodivir
Pimodivir will be administered as tablets taken orally, twice daily (2 tablets of 300 milligram [mg]) over a time period of 5 days.
Other Name: JNJ-63623872

Eligibility Criteria: 

Inclusion Criteria:

- The patient has an H7N9 Influenza A infection

- The patient has no known severe hepatic impairment

Exclusion Criteria:

- Any other Influenza A sub-strains other than H7N9

Eligibility Gender: 
Eligibility Age: 
Minimum: 13 Years

1-800-JANSSEN (1-800-526-7736)

Janssen Research & Development, LLC
EA Number: 
MeSH Terms: 
Influenza, Human, Influenza in Birds
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