EMEA-002115-PIP01-17-M06 - paediatric investigation plan
pretomanid
PIPHuman
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Key facts
- Invented name
- Dovprela (previously Pretomanid FGK)
- Active substance
- pretomanid
- Therapeutic area
- Infections and infestations
- Decision number
- P/0295/2024
- PIP number
- EMEA-002115-PIP01-17-M06
- Pharmaceutical form(s)
- Dispersible tablet
- Tablet
- Condition(s) / indication(s)
- Treatment of multi-drug-resistant tuberculosis
- Route(s) of administration
- Oral use
- Contact for public enquiries
Global Alliance for TB Drug Development
Tel. +1 2122277450
E-mail: info@tballiance.org- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Ne