Alpivab Biocryst · Withdrawn · authorised 13 Apr 2018 · ATC J05AH03
Therapeutic indication (EMA)
Alpivab is indicated for the treatment of uncomplicated influenza in adults and children from the age of 2 years.
Active substance
Peramivir
- US FDA 1
- EMA 1
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| RAPIVAB | 200MG/20ML (10MG/ML) | solution · intravenous | BIOCRYST | Prescription | 19 Dec 2014 |
EMA European Union — centrally authorised medicines
Safety signals and safety-related labeling changes
- US FDA 28 Jan 2021 RAPIVAB — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 31 Oct 2018 PRAC signal: Hepatic failure
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.