EMEA-002861-PIP02-20

Key facts

Active substance
highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2)
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0480/2020
PIP number
EMEA-002861-PIP02-20
Pharmaceutical form(s)
Concentrate for solution for injection
Condition(s) / indication(s)
Prevention of Coronavirus disease 2019 (COVID-19)
Route(s) of administration
Intramuscular use
Contact for public enquiries
BioNTech Manufacturing GmbH

E-mail: ruben.rizzi@biontech.de

Tel. +49 61319084-7593

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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