For help on how to get the results you want, see our search tips.
531 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Withdrawn applications Remove Withdrawn applications filter
Categories
Human Remove Human filter
PIP decision type
RP: decision refers to a refusal on a proposed Paediatric Investigation Plan Remove RP: decision refers to a refusal on a proposed Paediatric Investigation Plan filter
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
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Live, attenuated, chimeric dengue virus, serotype 1, live, attenuated dengue virus, serotype 2, live, attenuated, chimeric dengue virus, serotype 3, live attenuated, chimeric dengue virus, serotype 4
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-001888-PIP01-15, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 03/07/2017, Last updated: 29/04/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Norovirus GI.1 virus-like particle antigen, norovirus GII.4 virus-like particle antigen
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-001609-PIP01-14, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 05/06/2015, Last updated: 29/04/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (fitusiran)
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-001855-PIP01-15-M01, Route(s) of administration: Solution for injection, Pharmaceutical form(s): Subcutaneous use
Decision date: 04/12/2019, Last updated: 02/04/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain A (H1N1), Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain B (Victoria lineage), Influenza virus inactivated split virion (haemagglutinin and neuraminidase) of strain B (Yamagata lineage)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-001894-PIP01-15-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 04/11/2016, Last updated: 30/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Humanised chimeric antibody with a humanised H chain and a chimeric (mouse V-domain, human C-domain) L chain against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F (ABT-414)L chain against epidermal growth factor receptor conjugated to maleimidocaproylmonomethylauristatin F (ABT-414)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
PIP number: EMEA-001732-PIP02-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection or infusion
Decision date: 04/11/2016, Last updated: 07/08/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): 5-(4-Fluoro-1-benzothiophen-2-yl)-8-methyl-1,9-dihydro-2H-[1,3]oxazolo[4,5-H][2,3]benzodiazepin-2-one (S44819)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-002057-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 04/10/2017, Last updated: 27/06/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): axicabtagene ciloleucel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002010-PIP01-16-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 03/01/2019, Last updated: 08/04/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000275-PIP01-08, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Emulsion for injection
Decision date: 18/05/2009, Last updated: 08/03/2019, Compliance check: X -
List item
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 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Cyclic pyranopterin monophosphate (monohydrobromide dihydrate)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-001491-PIP01-13, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 21/03/2014, Last updated: 07/03/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066)
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-001527-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 24/07/2014, Last updated: 27/02/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001612-PIP01-14, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 22/12/2014, Last updated: 27/02/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Furosemide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Uro-nephrology
PIP number: EMEA-000982-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Orodispersible tablet
Decision date: 21/10/2011, Last updated: 02/10/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Gevokizumab
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-001487-PIP01-13, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 13/06/2014, Last updated: 02/10/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus H1 haemagglutinin, influenza virus H3 haemagglutinin /influenza virus haemagglutinin from strain B Victoria lineage, influenza virus haemagglutinin from strain B Yamagata lineage (expressed as virus-like particle [VLP])
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-002220-PIP01-17, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 11/04/2018, Last updated: 26/07/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ocaliva, Obeticholic acid
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-001304-PIP03-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Tablet
Decision date: 11/04/2018, Last updated: 25/07/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Teplizumab
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: P/8/2010, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 29/01/2010, Last updated: 16/07/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): thrombin alfa
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: Thrombin alfa, Route(s) of administration: Epilesional use, Pharmaceutical form(s): Powder and solvent for reconstitution
Decision date: 14/08/2008, Last updated: 06/07/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Olodaterol (hydrochloride)
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-001965-PIP01-16, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation solution
Decision date: 11/04/2017, Last updated: 05/07/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ cells transduced with lentiviral vector encoding the human beta-globin gene
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-001933-PIP01-16, Route(s) of administration: Intraosseous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 31/01/2017, Last updated: 29/06/2018, 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): Tanezumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pain
PIP number: EMEA-001635-PIP03-17, Route(s) of administration: Subcutaneous use, Intravenous 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): Adeno-associated viral vector serotype rh.10 carrying the humanNsulfoglucosamine Nsulfoglucosamine sulfohydrolase cDNA (LYS-SAF302)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-002122-PIP02-17, Route(s) of administration: Intracerebral use, Pharmaceutical form(s): Solution for infusion
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Plazomicin (sulfate)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001639-PIP02-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 19/03/2018, Last updated: 19/06/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Insulin human (NTRA-2112)
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-002116-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral solution
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: X