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709 results
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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): Colobreathe, Colistimethate sodium
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000176-PIP01-07-M05, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Capsule, hard
Decision date: 03/07/2017, Last updated: 25/07/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): relebactam (MK-7655A), cilastatin sodium, imipenem monohydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001809-PIP01-15-M01, Route(s) of administration: Parenteral use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 15/05/2019, Last updated: 30/10/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bydureon, exenatide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000689-PIP01-09-M09, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection, Powder and solvent for prolonged-release suspension for injection, Solution for injection in pre-filled injector
Decision date: 06/01/2020, Last updated: 11/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001915-PIP01-15-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 04/12/2019, Last updated: 02/04/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology, Ophthalmology
PIP number: EMEA-001039-PIP02-12-M04, Route(s) of administration: Intraglandular use, Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 30/03/2020, Last updated: 03/08/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dobutamine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001262-PIP01-12-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 03/07/2017, Last updated: 26/07/2017, Compliance check: X -
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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): Jardiance, empagliflozin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000828-PIP01-09-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/07/2018, Last updated: 22/11/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): N-[(1,3-dicyclohexyl-6-hydroxy-2,4-dioxo-1,2,3,4-tetrahydro-5-pyrimidinyl)carbonyl]glycine (GSK1278863)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001452-PIP01-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution, Oral suspension, Tablet
Decision date: 30/01/2018, Last updated: 18/04/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vosevi, Sofosbuvir, velpatasvir, voxilaprevi
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001822-PIP01-15-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 06/01/2020, Last updated: 12/06/2020, Compliance check: X -
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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): Sirturo, bedaquiline fumarate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000912-PIP01-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules
Decision date: 19/12/2018, Last updated: 18/02/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001715-PIP01-14-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 29/01/2020, Last updated: 12/06/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto, Venetoclax
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002018-PIP02-16-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Tablet for oral suspension
Decision date: 17/07/2019, Last updated: 18/11/2019, Compliance check: X -
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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): Domagrozumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001763-PIP01-15-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 31/10/2017, Last updated: 27/02/2019, Compliance check: X -
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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): Crizanlizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002141-PIP01-17-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 04/12/2019, Last updated: 02/04/2020, Compliance check: X -
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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): Romosozumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001075-PIP04-15-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/08/2018, Last updated: 05/02/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Maci, Matrix applied characterised autologous cultured chondrocytes
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000979-PIP01-10-M02, Route(s) of administration: Implant use, Pharmaceutical form(s): Implant
Decision date: 30/01/2018, Last updated: 18/04/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Liquid ethanolic extract 30 per cent (w/w) of Allium cepa L. (fresh bulb) and Citrus limon (L.) Burm. f. (fresh fruit), Paullinia cupana Kunth, Theobroma cacao L.
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001835-PIP01-15-M04, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 10/09/2019, Last updated: 26/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human alpha-galactosidase A (PRX 102)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001828-PIP01-15-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 12/09/2018, Last updated: 31/01/2019, Compliance check: X