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169 results
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Opinion/decision on a Paediatric investigation plan (PIP): Kineret, anakinra
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-001212-PIP01-11, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 28/03/2012, Last updated: 19/04/2012, Compliance check: V, 12/12/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Simponi, Golimumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000265-PIP01-08-M04, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Solution for injection, Solution for infusion
Decision date: 05/09/2014, Last updated: 29/09/2014, Compliance check: V, 10/10/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ilaris, Canakinumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000060-PIP04-14-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection, Powder for solution for injection, Powder and solvent for solution for injection
Decision date: 30/10/2015, Last updated: 06/01/2016, Compliance check: V, 26/02/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Antigen of pre-pandemic strain A/Vietnam/1203/2004 propagated in Vero cells
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000156-PIP01-07-M02, Route(s) of administration: Intramuscular injection, Pharmaceutical form(s): Suspension for injection
Decision date: 11/03/2011, Last updated: 08/04/2011, Compliance check: V, 17/01/2013 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tobi Podhaler, Tobramycin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000184-PIP01-08-M02, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, Capsule, hard
Decision date: 08/07/2014, Last updated: 05/08/2014, Compliance check: V, 12/09/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Orfadin, nitisinone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000784-PIP02-11-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension
Decision date: 30/10/2013, Last updated: 19/11/2013, Compliance check: V, 17/01/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: Human normal immunoglobulin, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 29/07/2011, Last updated: 15/09/2011, Compliance check: V, 15/10/2012 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ivemend, fosaprepitant
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000406-PIP01-08-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 22/01/2014, Last updated: 19/02/2014, Compliance check: V, 10/10/2014 -
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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): Tracleer, Bosentan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000425-PIP02-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 29/04/2013, Last updated: 31/05/2013, Compliance check: V, 21/03/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001797-PIP01-15-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 30/01/2018, Last updated: 19/04/2018, Compliance check: V, 21/09/2018 -
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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-PIP02-07-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 22/01/2014, Last updated: 19/02/2014, Compliance check: V, 29/01/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Anastrozole
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Anastrozole, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablets
Decision date: 06/02/2009, Last updated: 23/04/2009, Compliance check: V, 03/04/2009 -
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Opinion/decision on a Paediatric investigation plan (PIP): Abilify, aripiprazole
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-000235-PIP02-10-M02, Route(s) of administration: Oral use, Intramuscular use, Pharmaceutical form(s): Tablets, Orodispersible tablet, Oral solution, Solution for injection
Decision date: 26/10/2012, Last updated: 26/11/2012, Compliance check: V, 24/06/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Purified antigen fractions of inactivated split virion influenza virus type A, H1N1, influenza virus type A, H3N2, influenza virus type B, Victoria lineage, influenza virus type B, Yamagata lineage
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000817-PIP02-11-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 30/07/2013, Last updated: 19/01/2012, Compliance check: V, 21/04/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Orencia, Abatacept
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000118-PIP02-10-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/03/2018, Last updated: 06/06/2018, Compliance check: V, 23/03/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Tiotropium bromide (monohydrate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000035-PIP01-07-M05, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Solution for inhalation via the Respimat inhaler
Decision date: 04/06/2012, Last updated: 23/07/2012, Compliance check: V, 21/08/2012 -
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Opinion/decision on a Paediatric investigation plan (PIP): HyQvia, Human normal immunoglobulin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000872-PIP01-10-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for infusion
Decision date: 27/08/2015, Last updated: 13/11/2015, Compliance check: V, 30/10/2015 -
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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): Nomegestrol acetate, 17 beta-estradiol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000250-PIP01-08-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 09/03/2010, Last updated: 28/07/2010, Compliance check: V, 21/05/2010 -
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Opinion/decision on a Paediatric investigation plan (PIP): Cholestagel, Colesevelam hydrochloride
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Colesevelam hydrochloride, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/06/2009, Last updated: 11/08/2009, Compliance check: V, 24/07/2009 -
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Opinion/decision on a Paediatric investigation plan (PIP): Zinforo, Ceftaroline fosamil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000769-PIP01-09-M08, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 15/06/2018, Last updated: 28/11/2018, Compliance check: V, 19/10/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Mimpara, cinacalcet hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000078-PIP01-07-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate dosage form, other
Decision date: 12/05/2017, Last updated: 02/03/2018, Compliance check: V, 19/05/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Voncento, Human coagulation factor VIII, von Willebrand factor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000312-PIP01-08-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection, Powder and solvent for solution for infusion
Decision date: 28/10/2014, Last updated: 27/07/2015, Compliance check: V, 22/05/2015 -
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Opinion/decision on a Paediatric investigation plan (PIP): Travatan, travoprost
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-001271-PIP01-12-M01, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 29/11/2013, Last updated: 02/03/2018, Compliance check: V, 23/05/2014