Key facts

Invented name
  • Deltyba
  • Deltyba
Active Substance
Delamanid
Therapeutic area
Infectious diseases
Decision number
P/0271/2019
PIP number
EMEA-001113-PIP01-10-M06
Pharmaceutical form(s)
  • Film-coated tablet
  • Dispersible tablet
Condition(s) / indication(s)
Treatment of multi-drug-resistant tuberculosis
Route(s) of administration
Oral use
Contact for public enquiries

Otsuka Pharmaceutical Development & Commercialisation Europe GmbH

Tel. +49 6995 5044321
E-mail: paediatric-info@otsuka.de

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001113-PIP01-10-M06
Compliance opinion date
Compliance outcome
Positive

Decision

P/0271/2019: EMA decision of 14 August 2019 on the acceptance of a modification of an agreed paediatric investigation plan for delamanid (Deltyba), (EMEA-001113-PIP01-10-M06)

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