EMEA-001017-PIP01-10-M01 - paediatric investigation plan

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/0083/2019

PIP number

EMEA-001017-PIP01-10-M01

Pharmaceutical form(s)

Oromucosal drops

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

22/03/2019

Compliance check done

No

Decision

P/0083/2019: 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-001017-PIP01-10-M01)

Adopted

Reference Number:

EMA/130571/2019

English (EN) (169.28 KB - PDF)

First published:

24/06/2019

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Related content

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

English (EN) (83.63 KB - PDF)

First published:

08/05/2026

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