For help on how to get the results you want, see our search tips.
49 results
Medicine
Paediatric investigation plans Remove Paediatric investigation plans filter
Periodic safety update report single assessments Remove Periodic safety update report single assessments filter
PIP decision type
RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) Remove RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) filter
RPM: decision refers to a refusal on the application for modification of an agreed PIP Remove RPM: decision refers to a refusal on the application for modification of an agreed PIP filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Zynteglo, betibeglogene autotemcel (updated)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001665-PIP01-14-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Modified allergen extract of birch pollen
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000932-PIP01-10-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus, Dermatophagoides farinae
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001014-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
Decision date: 22/03/2019, Last updated: 13/12/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001016-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
Decision date: 22/03/2019, Last updated: 13/12/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): birch pollen, alder pollen
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001012-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
Decision date: 22/03/2019, Last updated: 13/12/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002153-PIP01-17-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, pre-dispensed
Decision date: 14/02/2020, Last updated: 10/12/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Reagila, Cariprazine (hydrochloride)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001652-PIP01-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 17/03/2021, Last updated: 26/11/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus, Dermatophagoides farinae
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001011-PIP01-10-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/03/2019, Last updated: 12/02/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): birch pollen, alder pollen
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001013-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal drops
Decision date: 22/03/2019, Last updated: 12/02/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001017-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal drops
Decision date: 22/03/2019, Last updated: 12/02/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Betmiga, Mirabegron
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000597-PIP02-10-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Polonged-release granules for oral suspension, Prolonged-release tablet
Decision date: 30/09/2019, Last updated: 26/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Non-pathogenic bacterial lysate of Escherichia coli and Enterococcus faecalis
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002155-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Human Neutrophil Elastase Inhibitor (CHF6333)
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002196-PIP01-17, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Pressurised inhalation, suspension
Decision date: 01/12/2017, Last updated: 07/03/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Mircera, Methoxy polyethylene glycol-epoetin beta
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000172-PIP01-07-M03, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 31/10/2017, Last updated: 13/02/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Chlorhexidine gluconate, isopropyl alcohol
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000989-PIP01-10-M02, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Solution
Decision date: 11/08/2017, Last updated: 02/10/2017, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Akynzeo, Fosnetupitant, Palonosetron
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Other
PIP number: EMEA-001198-PIP02-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 21/12/2016, Last updated: 31/01/2017, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Antithrombin alfa
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001154-PIP02-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 02/12/2016, Last updated: 30/01/2017, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Terguride (hydrogenmaleate)
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002015-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 02/12/2016, Last updated: 30/01/2017, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Levomilnacipran
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Neurology
PIP number: EMEA-001724-PIP01-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release capsule, Capsule, hard
Decision date: 05/06/2015, Last updated: 02/09/2015, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-[3-({Benzoxazol-2-yl[3-(4-methoxyphenoxy)propyl]amino}methyl)phenoxy]butanoic acid
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001573-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 03/09/2014, Last updated: 14/11/2014, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Acotiamide
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001461-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Coated tablet
Decision date: 05/09/2013, Last updated: 08/10/2013, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Esketamine
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Psychiatry
PIP number: EMEA-001428-PIP01-13, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray, Solution
Decision date: 30/07/2013, Last updated: 03/09/2013, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tivantinib
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Oncology
PIP number: EMEA-001284-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 24/07/2012, Last updated: 22/08/2012, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): ATryn, Antithrombin alfa
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001154-PIP01-11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 27/09/2011, Last updated: 18/10/2011, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Aciclovir
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001066-PIP01-10, Route(s) of administration: Gingival use, Pharmaceutical form(s): Muco-adhesive buccal tablet
Decision date: 06/04/2011, Last updated: 12/05/2011, Compliance check: X