EMEA-003283-PIP01-22 - paediatric investigation plan
dexmedetomidine
PIPHuman
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Key facts
- Active substance
- dexmedetomidine
- Therapeutic area
- Anaesthesiology
- Decision number
- P/0362/2023
- PIP number
- EMEA-003283-PIP01-22
- Pharmaceutical form(s)
- Nasal spray (solution)
- Condition(s) / indication(s)
- Sedation
- Route(s) of administration
- Intranasal use
- Contact for public enquiries
Cessatech A/S
E-mail: info@cessatech.com
Tel: +45 93872309- Decision type
- P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
- Compliance check done
- Ne