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169 results
Medicine
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Opinion/decision on a Paediatric investigation plan (PIP): Votubia, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000019-PIP08-12-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 31/10/2017, Last updated: 13/02/2018, Compliance check: V, 01/06/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Damoctocog alfa pegol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001229-PIP01-11-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 10/07/2017, Last updated: 26/07/2017, Compliance check: V, 18/08/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Trifarotene
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001492-PIP01-13-M01, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cream
Decision date: 11/04/2017, Last updated: 29/05/2017, Compliance check: V, 29/06/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Circadin, melatonin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000440-PIP02-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet, Age-appropriate oral solid dosage form
Decision date: 06/04/2017, Last updated: 29/05/2017, Compliance check: V, 21/04/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lucentis, ranibizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-000527-PIP04-13-M01, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Solution for injection
Decision date: 31/01/2017, Last updated: 20/03/2017, Compliance check: V, 19/10/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Yervoy, Ipilimumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000117-PIP02-10-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 12/01/2017, Last updated: 20/03/2017, Compliance check: V, 24/02/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): elvitegravir, emtricitabine, tenofovir disoproxil (as fumarate), cobicistat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000970-PIP01-10-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2016, Last updated: 19/01/2017, Compliance check: V, 16/12/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Firazyr, icatibant acetate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000408-PIP01-08-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 30/10/2015, Last updated: 21/12/2016, Compliance check: V, 19/08/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Pitavastatin (calcium)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000300-PIP01-08-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/04/2016, Last updated: 21/12/2016, Compliance check: V, 19/08/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Inovelon, Rufinamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000709-PIP01-09-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Oral suspension
Decision date: 15/04/2016, Last updated: 21/12/2016, Compliance check: V, 16/09/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Levamisole (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001885-PIP01-15-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 08/07/2016, Last updated: 21/12/2016, Compliance check: V, 22/07/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): hydrocortisone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001283-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules
Decision date: 26/02/2013, Last updated: 21/12/2016, Compliance check: V, 14/10/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Pitavastatin (calcium)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000054-PIP01-07-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/04/2016, Last updated: 21/12/2016, Compliance check: V, 19/08/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Exjade, deferasirox
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001103-PIP01-10-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Dispersible tablet, Film-coated tablet, Granules
Decision date: 30/06/2016, Last updated: 21/12/2016, Compliance check: V, 14/10/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Humira, adalimumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000366-PIP05-12-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 22/07/2016, Last updated: 21/12/2016, Compliance check: V, 14/10/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tasigna, nilotinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000290-PIP01-08-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 21/12/2015, Last updated: 21/12/2016, Compliance check: V, 11/11/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Kuvan, Sapropterin dihydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001476-PIP01-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Soluble tablet, Powder for oral solution
Decision date: 09/09/2016, Last updated: 27/10/2016, Compliance check: V, 10/10/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Unituxin, Dinutuximab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001285-PIP01-12-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 12/08/2016, Last updated: 27/10/2016, Compliance check: V, 16/12/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Synflorix, Pneumococcal polysaccharide serotype 1 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein, pneumococcal polysaccharide serotype 4 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein, pneumococcal polysaccharide serotype 5 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein...
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000673-PIP01-09-M09, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 12/08/2016, Last updated: 27/10/2016, Compliance check: V, 27/01/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Benlysta, belimumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000520-PIP01-08-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 15/07/2016, Last updated: 23/09/2016, Compliance check: V, 16/11/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Revolade, Eltrombopag
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000170-PIP01-07-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension, Film-coated tablet
Decision date: 16/06/2016, Last updated: 26/08/2016, Compliance check: V, 14/11/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Aranesp, darbepoetin alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000329-PIP02-09-M05, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 14/06/2016, Last updated: 26/08/2016, Compliance check: X, 24/03/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Drospirenone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001495-PIP01-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 20/05/2016, Last updated: 27/07/2016, Compliance check: V, 23/03/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human Wiskott Aldrich Syndrome (WAS) cDNA sequence
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001792-PIP01-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 18/03/2016, Last updated: 25/04/2016, Compliance check: V, 24/03/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tetracaine (hydrochloride), oxymetazoline (hydrochloride)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Anaesthesiology
PIP number: EMEA-001764-PIP03-15, Route(s) of administration: Nasal use, Pharmaceutical form(s): Nasal spray, solution
Decision date: 18/03/2016, Last updated: 25/04/2016, Compliance check: V, 21/04/2017