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233 results
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human beta-glucuronidase (rhGUS, UX003) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001540-PIP01-13-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 28/07/2016, Last updated: 16/06/2022, Compliance check: V, 11/12/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Xagrid, Anagrelide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000720-PIP01-09-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 19/12/2013, Last updated: 09/12/2021, Compliance check: V, 14/02/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): sebelipase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001331-PIP01-12-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 07/08/2015, Last updated: 21/09/2021, Compliance check: V, 01/03/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Prolia, denosumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000145-PIP01-07-M09, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/03/2018, Last updated: 21/09/2021, Compliance check: V, 01/03/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): MabThera, rituximab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000308-PIP02-11-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 18/03/2016, Last updated: 21/09/2021, Compliance check: V, 01/02/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Harvoni, Sofosbuvir, ledipasvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001411-PIP01-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form, Age-appropriate dosage form, other
Decision date: 16/03/2017, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Emicizumab
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-001839-PIP01-15, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/07/2016, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): NovoEight, turoctocog alpha
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000428-PIP01-08-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 12/08/2016, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Keytruda, Anti-PD1 humanized monoclonal antibody of the IgG4/kappa class (MK-3475) (pembrolizumab)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001474-PIP01-13-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion, Concentrate for solution for infusion
Decision date: 16/02/2018, Last updated: 21/09/2021, Compliance check: V, 01/02/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Humenza, Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000669-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for injection
Decision date: 04/01/2019, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000055-PIP01-07-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Gastro-resistant granules, Gastro-resistant tablet
Decision date: 03/12/2018, Last updated: 21/09/2021, Compliance check: V, 01/02/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Beclometasone dipropionate, formoterol fumarate dihydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000548-PIP01-09-M08, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, Pressurised inhalation, solution
Decision date: 15/06/2018, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ecalta, anidulafungin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000469-PIP01-08-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 17/03/2017, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ruconest, Conestat alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000367-PIP01-08-M08, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection, Powder and solvent for solution for injection
Decision date: 08/11/2018, Last updated: 21/09/2021, Compliance check: V, 01/03/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Sovaldi, Sofosbuvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001276-PIP01-12-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form, Other
Decision date: 15/06/2018, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Nimenrix, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W polysaccharide conjugated to tetanus toxoid, N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000429-PIP01-08-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 08/05/2015, Last updated: 21/09/2021, Compliance check: V, 26/04/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Elocta, Efmorocotocog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001114-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 14/06/2016, Last updated: 21/09/2021, Compliance check: V, 29/05/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Stelara, Ustekinumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000311-PIP01-08-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/01/2016, Last updated: 21/09/2021, Compliance check: V, 29/05/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): MabThera, rituximab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000308-PIP01-08-M04, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 22/03/2019, Last updated: 21/09/2021, Compliance check: V, 29/05/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Pegasys, peginterferon alfa-2a
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000298-PIP01-08-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 07/05/2018, Last updated: 21/09/2021, Compliance check: V, 29/05/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Xarelto, rivaroxaban
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000430-PIP01-08-M11, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Film-coated tablet
Decision date: 17/04/2019, Last updated: 21/09/2021, Compliance check: V, 20/09/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Terbinafine hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001259-PIP02-13-M02, Route(s) of administration: Topical use, Pharmaceutical form(s): Medicated nail lacquer
Decision date: 17/06/2019, Last updated: 21/09/2021, Compliance check: V, 26/07/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Pradaxa, Dabigatran etexilate mesilate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases; Haematology-Hemostaseology
PIP number: EMEA-000081-PIP01-07-M11, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form, other
Decision date: 07/12/2018, Last updated: 21/09/2021, Compliance check: V, 23/08/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Caplacizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001157-PIP01-11-M02, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 12/09/2018, Last updated: 21/09/2021, Compliance check: V, 23/08/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Velphoro, Sucroferric oxyhydroxide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001061-PIP01-10-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension, Chewable tablet
Decision date: 17/07/2018, Last updated: 21/09/2021, Compliance check: V, 20/09/2019