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6 results
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Medicine
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Paediatric investigation plans Remove Paediatric investigation plans filter
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PIP decision type
PM: decision on the application for modification of an agreed PIP Remove PM: decision on the application for modification of an agreed PIP filter
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) Remove P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter
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Opinion/decision on a Paediatric investigation plan (PIP): Lojuxta, Lomitapide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001124-PIP01-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form, other
Decision date: 10/09/2019, Last updated: 26/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Strensiq, asfotase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000987-PIP01-10-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/05/2019, Last updated: 30/10/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Foclivia, Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001830-PIP01-15-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 15/08/2018, Last updated: 31/01/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Obizur, susoctocog alfa
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000753-PIP02-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Glybera, alipogene tiparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000292-PIP01-08-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 04/11/2016, Last updated: 23/01/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pumarix, Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005(H5N1) like strain used (PR8-IBCDC-RG2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000178-PIP01-07-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 08/05/2015, Last updated: 15/06/2015, Compliance check: X