For help on how to get the results you want, see our search tips.
2105 results
Keyword Remove keyword
Medicine
Paediatric investigation plans Remove Paediatric investigation plans filter
Summaries of opinion Remove Summaries of opinion filter
Categories
Human Remove Human filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Anti proprotein convertase subtilisin kexin type 9 humanized monoclonal antibody (PF-04950615)
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: EMEA-001430-PIP01-13, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 02/04/2014, Last updated: 07/12/2016, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Aqueous allergen extract of grass and cereal pollen
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-000964-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oral solution
Decision date: 22/12/2010, Last updated: 25/01/2011, 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): Flibanserin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Flibanserin, Route(s) of administration: Oral, Pharmaceutical form(s): Film-coated tablet
Decision date: 28/04/2008, Last updated: 16/05/2008, Compliance check: X -
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): Allergen extract of Alnus glutinosa pollen
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-000906-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal drops
Decision date: 03/12/2010, Last updated: 11/01/2011, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Anifrolumab
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-001435-PIP02-16, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Delafloxacin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001080-PIP01-10, Route(s) of administration: Intravenous use Oral Use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 08/04/2011, Last updated: 12/05/2011, Compliance check: X -
List item
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: 22/09/2016, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): exenatide
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: EMEA-001755-PIP01-15, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Implant
Decision date: 18/03/2016, Last updated: 25/04/2016, Compliance check: X -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): 1H-Isoindol-1-one,2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]-4-piperidinyl]methyl]-2,3-dihydro-,hydrochloride, hydrate (1:1:2) (MIN-101)
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Psychiatry
PIP number: EMEA-002222-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Gastro-resistant tablet
Decision date: 08/11/2017, Last updated: 12/02/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine besylate, valsartan, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000744-PIP01-09, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 25/01/2010, Last updated: 25/02/2010, Compliance check: X -
List item
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 -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Misoprostol
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: EMEA-001601-PIP01-13, Route(s) of administration: Oral use, Sublingual use, Vaginal use, Pharmaceutical form(s): Tablet
Decision date: 05/06/2015, Last updated: 02/09/2015, Compliance check: X -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Testosterone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Testosterone, Route(s) of administration: Transdermal use, Pharmaceutical form(s): Transdermal patch
Decision date: 11/08/2009, Last updated: 22/10/2009, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, amlodipine, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001942-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 12/08/2016, Last updated: 28/10/2016, Compliance check: X -
List item
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 -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Galafold, migalastat hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001194-PIP01-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Dispersible tablet
Decision date: 17/04/2019, Last updated: 24/06/2019, Compliance check: X -
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): Risperidone
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Psychiatry
PIP number: EMEA-001034-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 06/07/2011, Last updated: 09/08/2011, 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