EMEA-002915-PIP01-20-M03 - paediatric investigation plan
SARS-CoV2 prefusion Spike delta TM (CoV-2 preS dTM) adjuvanted with AS03
PIPHuman
Key facts
- Invented name
- VidPrevtyn Beta
- Active Substance
- SARS-CoV2 prefusion Spike delta TM (CoV-2 preS dTM) adjuvanted with AS03
- Therapeutic area
- Vaccines
- Decision number
- P/0072/2024
- PIP number
- EMEA-002915-PIP01-20-M03
- Pharmaceutical form(s)
- Solution and emulsion for emulsion for injection
- Condition(s) / indication(s)
- Prevention of Coronavirus disease 2019 (COVID-19)
- Route(s) of administration
- Intramuscular use
- Contact for public enquiries
Sanofi Pasteur
E-mail: contact-us@sanofi.com
Tel. +33 1 6974 5695- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date