EMA/PE/0000228372

Key facts

Active substance

borrelia outer surface protein A (OspA) serotypes (ST1-6) lipidated, fusion protein vaccine

Therapeutic area

Infections and infestations

Decision number

EMA/PE/0000228372

PIP number

EMA/PE/0000228372

Pharmaceutical form(s)

Suspension for injection in pre-filled syringe

Condition(s) / indication(s)

Prevention of Lyme disease

Route(s) of administration

Intramuscular use

Contact for public enquiries

Pfizer Europe MA EEIG E-mail: [email protected] Tel.: +44 (0)1304616161

Decision type

PM: decision on the application for modification of an agreed PIP

Decision date

14/04/2025

Compliance check done

No

Decision

EMA/PE/0000228372 : EMA decision of 14 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for Borrelia outer surface protein A (OspA) serotypes (ST1-6) lipidated, fusion protein vaccine

Adopted

Reference Number:

EMADOC-1700519818-2036729

English (EN) (242.48 KB - PDF)

First published:

03/07/2026

View