Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) (pandemic influenza vaccine (H5N1) (live attenuated, nasal))
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- pandemic influenza vaccine (H5N1) (live attenuated, nasal)
- Company
- AstraZeneca AB
- Status
- Authorised
- Therapeutic area
- Influenza, Human
- CHMP opinion
- Thu 31 Mar 2016
- EU approval
- Fri 20 May 2016
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/003963
- ATC
- J07BB03
- Official record
- www.ema.europa.eu
Indication
Prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age. Pandemic influenza vaccine H5N1 AstraZeneca should be used in accordance with official guidance
Regulatory milestones
No milestones recorded in the last year.
Follow Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.