EMEA-001016-PIP01-10-M01 - paediatric investigation plan | European Medicines Agency (EMA)
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EMEA-001016-PIP01-10-M01 - paediatric investigation plan
Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
PIPHuman
Key facts
Active Substance
Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
Therapeutic area
Pneumology-allergology
Decision number
P/0084/2019
PIP number
EMEA-001016-PIP01-10-M01
Pharmaceutical form(s)
Coated tablet
Condition(s) / indication(s)
Treatment of allergic rhinitis / rhino-conjunctivitis
Route(s) of administration
Sublingual use
Decision type
RPM: decision refers to a refusal on the application for modification of an agreed PIP
Decision date
Decision
P/0084/2019: EMA decision of 22 March 2019 on the refusal of a modification of an agreed paediatric investigation plan for chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis (EMEA-001016-PIP01-10-M01)
Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision