Key facts

Active Substance
(R)-azasetron (besilate) (SENS-401)
Therapeutic area
Oto-rhino-laryngology
Decision number
P/0105/2019
PIP number
EMEA-002165-PIP02-18
Pharmaceutical form(s)
  • Tablet
  • Powder for oral solution
  • Orodispersible tablet
Condition(s) / indication(s)
Prevention of platinum-induced ototoxic hearing loss
Route(s) of administration
Oral use
Contact for public enquiries

Sensorion SA

E-mail: contact@sensorion-pharma.com
Tel.  +33  4672 07730

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

Decision

P/0105/2019: EMA decision of 22 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (R)-azasetron (besylate) (SENS-401) (EMEA-002165-PIP02-18)

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