EMEA-001011-PIP01-10-M01 - paediatric investigation plan | European Medicines Agency (EMA)
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EMEA-001011-PIP01-10-M01 - paediatric investigation plan
Dermatophagoides pteronyssinus
Dermatophagoides farinae
PIPHuman
Key facts
Active Substance
Dermatophagoides pteronyssinus
Dermatophagoides farinae
Therapeutic area
Pneumology-allergology
Decision number
P/0087/2019
PIP number
EMEA-001011-PIP01-10-M01
Pharmaceutical form(s)
Suspension for injection
Condition(s) / indication(s)
Treatment of allergic rhinitis / rhino-conjunctivitis
Route(s) of administration
Subcutaneous use
Decision type
RPM: decision refers to a refusal on the application for modification of an agreed PIP
Decision date
Decision
P/0087/2019: EMA decision of 22 March 2019 on the refusal of a modification of an agreed paediatric investigation plan for chemically modified house dust mites allergen extract of Dermatophagoides pteronyssinus and ... (EMEA-001011-PIP01-10-M01)