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Paediatric investigation plans Remove Paediatric investigation plans filter Referrals Remove Referrals filter European public assessment reports (EPAR) (48) Apply European public assessment reports (EPAR) filter Summaries of opinion (2) Apply Summaries of opinion filter Withdrawn applications (4) Apply Withdrawn applications filter Orphan designations (28) Apply Orphan designations filter Direct healthcare professional communication (10) Apply Direct healthcare professional communication filter

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Opinion/decision on a Paediatric investigation plan (PIP): Arepanrix, Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000687-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for emulsion for injection
Decision date: 09/08/2010, Last updated: 07/10/2010, Compliance check: V, 12/12/2014
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Opinion/decision on a Paediatric investigation plan (PIP): Gavreto, pralsetinib

Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002575-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 09/07/2021, Last updated: 22/07/2022, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Lorviqua, Lorlatinib

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002669-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/01/2021, Last updated: 29/09/2021, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Gavreto, pralsetinib

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002575-PIP03-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Enhertu, trastuzumab deruxtecan

Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002978-PIP01-21, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 08/07/2021, Last updated: 19/07/2022, Compliance check: X

30 results

Opinion/decision on a Paediatric investigation plan (PIP): Arepanrix, Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009

Opinion/decision on a Paediatric investigation plan (PIP): Gavreto, pralsetinib

Opinion/decision on a Paediatric investigation plan (PIP): Lorviqua, Lorlatinib

Opinion/decision on a Paediatric investigation plan (PIP): Gavreto, pralsetinib

Opinion/decision on a Paediatric investigation plan (PIP): Enhertu, trastuzumab deruxtecan