EMEA-002155-PIP01-17 - paediatric investigation plan

Non-pathogenic bacterial lysate of Escherichia coli and Enterococcus faecalis
PIPHuman

Key facts

Active Substance
Non-pathogenic bacterial lysate of Escherichia coli and Enterococcus faecalis
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0095/2018
PIP number
EMEA-002155-PIP01-17
Pharmaceutical form(s)
Age-appropriate oral liquid dosage form
Condition(s) / indication(s)
Treatment of irritable bowel syndrome (IBS)
Route(s) of administration
Oral use
Contact for public enquiries

SymbioPharm GmbH

Tel. +41 613120510
E-mail: klaus.rose@klausrose.net

Decision type
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Decision date

Decision

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