For help on how to get the results you want, see our search tips.
708 results
Keyword Remove keyword
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Eperzan, Albiglutide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001175-PIP01-11-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 07/10/2016, Last updated: 24/11/2016, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Imipenem (monohydrate), cilastatin (sodium), relebactam (MK-7655A)
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 -
List item
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 -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tecfidera, dimethyl fumarate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000832-PIP01-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 30/06/2017, Last updated: 25/07/2017, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): fostemsavir (tromethamine)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001687-PIP01-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 29/01/2019, Last updated: 29/04/2019, Compliance check: X -
List item
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 -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Epclusa, Sofosbuvir, velpatasvir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001646-PIP01-14-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 18/05/2018, Last updated: 28/11/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extract of birch, alder and hazel pollen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000662-PIP02-09-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/01/2014, Last updated: 20/02/2014, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ixiaro, Japanese encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000559-PIP01-09-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 04/10/2017, Last updated: 02/03/2018, Compliance check: V, 10/11/2017 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Surotomycin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001226-PIP01-11-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 30/01/2015, Last updated: 05/03/2015, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Vimizim, Recombinant human N-acetylgalactosamine-6-sulfatase (BMN110)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000973-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 30/03/2015, Last updated: 06/05/2015, Compliance check: X -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dexxience, Betrixaban
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001834-PIP02-16-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 18/06/2018, Last updated: 27/06/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Lebrikizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001053-PIP01-10-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 27/11/2015, Last updated: 08/12/2016, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Modified grass-pollen extract
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000284-PIP01-08-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 03/09/2013, Last updated: 08/10/2013, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Deferiprone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001126-PIP01-10-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 15/05/2019, Last updated: 30/10/2019, Compliance check: X -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tapentadol (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: EMEA-000494-PIP01-08-M09, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Oral solution, Solution for injection/infusion
Decision date: 18/03/2016, Last updated: 25/04/2016, Compliance check: X -
List item
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: 15/02/2019, Compliance check: X -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Acalabrutinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001796-PIP03-16-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral liquid dosage form, Age-appropriate oral solid dosage form
Decision date: 15/03/2019, Last updated: 24/06/2019, Compliance check: X -
List item
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 -
List item
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