EMA/PE/0000244980 - paediatric investigation plan
mirabegron
solifenacin
PIPHuman
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Key facts
- Active substance
- mirabegron
- solifenacin
- Therapeutic area
- Renal and urinary disorders
- Decision number
- EMA/PE/0000244980
- PIP number
- EMA/PE/0000244980
- Pharmaceutical form(s)
- Tablet
- Condition(s) / indication(s)
- Treatment of neurogenic detrusor overactivity
- Route(s) of administration
- Oral use
- Contact for public enquiries
Propharma Group The Netherlands B.V.
E-mail: Bianca.Sirbu@adalvo.com
Tel.: +40 724299861- Decision type
- W: decision granting a waiver in all age groups for all conditions or indications
- Decision date
- Compliance check done
- Nie