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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): 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): 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): 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): 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): 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): 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): Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigen: Pertussis toxoid, Bordetella pertussis antigen: Filamentous Haemagglutinin, Bordetella pertussis antigen: Pertactin, Inactivated poliovirus: type 1 (Mahoney strain), Inactivated poliovirus: type 2 (MEF-1 strain), Inactivated poliovirus: type 3 (Saukett strain)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000500-PIP01-08-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection, Suspension for injection in pre-filled syringe
Decision date: 07/03/2015, Last updated: 25/03/2015, Compliance check: V, 27/05/2016 -
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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-PIP02-09-M02, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation solution, Inhalation powder, Capsule, hard
Decision date: 30/01/2015, Last updated: 05/03/2015, Compliance check: V, 27/05/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Sodium benzylpenilloate, benzylpenicilloyl octa- L-lysine
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Diagnostic
PIP number: EMEA-001398-PIP02-13, Route(s) of administration: Skin scarification, Intradermal use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 29/11/2013, Last updated: 06/01/2014, Compliance check: V, 12/09/2014 -
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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): ViraferonPeg, peginterferon alfa-2b
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000384-PIP01-08, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection in vial and in pre-filled pen
Decision date: 14/10/2008, Last updated: 24/11/2008, Compliance check: V, 17/10/2008 -
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Opinion/decision on a Paediatric investigation plan (PIP): Latanoprost
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: Latanoprost, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 03/11/2009, Last updated: 23/12/2009, Compliance check: V, 19/03/2010 -
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Opinion/decision on a Paediatric investigation plan (PIP): Adenovirus associated viral vector serotype 2 containing the human RPE65 gene
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Ophthalmology
PIP number: EMEA-001684-PIP01-14, Route(s) of administration: Intraocular use, Pharmaceutical form(s): Solution for injection
Decision date: 02/10/2015, Last updated: 07/03/2019, Compliance check: V, 21/04/2017 -
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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: Haematology-Hemostaseology
PIP number: EMEA-001110-PIP01-10-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 20/07/2012, Last updated: 22/08/2012, Compliance check: V, 11/10/2013 -
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Opinion/decision on a Paediatric investigation plan (PIP): Nonacog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001139-PIP01-11-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 29/01/2016, Last updated: 29/03/2016, Compliance check: V, 29/06/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Gadobutrol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Diagnostic
PIP number: EMEA-000994-PIP01-10-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 19/12/2012, Last updated: 04/02/2014, Compliance check: V, 20/06/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Azelastine (hydrochloride), fluticasone propionate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000990-PIP02-10, Route(s) of administration: Nasal use, Pharmaceutical form(s): Nasal spray, suspension
Decision date: 06/04/2011, Last updated: 12/05/2011, Compliance check: V, 24/06/2011 -
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Opinion/decision on a Paediatric investigation plan (PIP): Ozenoxacin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000981-PIP01-10-M04, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cream
Decision date: 08/07/2014, Last updated: 05/08/2014, Compliance check: V, 29/01/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Bilastine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000347-PIP01-08-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Orodispersible tablet, Oral liquid
Decision date: 04/09/2015, Last updated: 15/06/2015, Compliance check: V, 13/11/2015 -
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Opinion/decision on a Paediatric investigation plan (PIP): valsartan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000005-PIP01-07-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate liquid dosage form
Decision date: 26/06/2009, Last updated: 22/10/2009, Compliance check: V, 21/08/2009 -
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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-000830-PIP02-10-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 03/12/2015, Last updated: 02/02/2016, Compliance check: V, 29/01/2016 -
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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): Solifenacin (succinate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000573-PIP01-09-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Film-coated tablet
Decision date: 29/09/2014, Last updated: 27/07/2015, Compliance check: V, 22/05/2015 -
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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