EMA/PE/0000232767 - paediatric investigation plan

ve303-07: bacilli, strain from cluster xvii, (closest relative: clostridium_aq innocuum) liveve303-07
ve303-06: clostridia, strain from cluster xiva, (closest relative: dorea_a longicatena) live
ve303-05: clostridia, strain from cluster xiva, (closest relative: blautia sp001304935) live
ve303-03: clostridia, strain from cluster xiva, (closest relative: sellimonas intestinalis) live
ve303-02: clostridia, strain from cluster iv, (closest relative: anaerotruncus colihominis) liveve303-02
ve303-01: clostridia, strain from cluster xiva (closest relative: enterocloster bolteae) live
ve303-08: clostridia, strain from cluster iv, (closest relative: flavonifractor plautii), live
ve303-04: clostridia, strain from cluster xiva, (closest relative: clostridium_q symbiosum) live (ve303)
PIPHuman

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Key facts

Active substance
  • ve303-07: bacilli, strain from cluster xvii, (closest relative: clostridium_aq innocuum) liveve303-07
  • ve303-06: clostridia, strain from cluster xiva, (closest relative: dorea_a longicatena) live
  • ve303-05: clostridia, strain from cluster xiva, (closest relative: blautia sp001304935) live
  • ve303-03: clostridia, strain from cluster xiva, (closest relative: sellimonas intestinalis) live
  • ve303-02: clostridia, strain from cluster iv, (closest relative: anaerotruncus colihominis) liveve303-02
  • ve303-01: clostridia, strain from cluster xiva (closest relative: enterocloster bolteae) live
  • ve303-08: clostridia, strain from cluster iv, (closest relative: flavonifractor plautii), live
  • ve303-04: clostridia, strain from cluster xiva, (closest relative: clostridium_q symbiosum) live (ve303)
Therapeutic area
Infections and infestations
Decision number
EMA/PE/0000232767
PIP number
EMA/PE/0000232767
Pharmaceutical form(s)
Capsule, hard
Condition(s) / indication(s)
Prevention of Clostridium difficile infection (CDI)
Route(s) of administration
Oral use
Contact for public enquiries

Vedanta Biosciences Inc. 
Tel: 857-706-1427

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

Decision

EMA/PE/0000232767 : EMA decision of 16 May 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for VE303-07: Bacilli, strain from cluster XVII......(VE303)

Adopted Reference Number: EMADOC-1700519818-2115976

English (EN) (281.21 KB - PDF)

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