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61 results
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Opinion/decision on a Paediatric investigation plan (PIP): Daklinza, Daclatasvir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001191-PIP01-11-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Chewable tablet, Film-coated tablet
Decision date: 08/11/2019, Last updated: 30/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Prepandrix, Purified antigen fractions of inactivated split virion Influenza A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14), Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000160-PIP01-07-M05, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 14/08/2019, Last updated: 21/09/2021, Compliance check: V, 31/01/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Lartruvo, Olaratumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001760-PIP01-15-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/03/2019, Last updated: 08/10/2021, Compliance check: X -
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Orphan designation: Ketoconazole for: Treatment of Cushing's syndrome
Date of designation: 23/04/2012, Positive, Last updated: 22/09/2020 -
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Orphan designation: ciclosporin for: Treatment of vernal keratoconjunctivitis
Date of designation: 06/04/2006, Positive, Last updated: 12/07/2018 -
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Orphan designation: Antisense oligonucleotide targeted to the SMN2 gene (nusinersen) for: Treatment of 5q spinal muscular atrophy
Date of designation: 02/04/2012, Positive, Last updated: 16/10/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Spinraza, Nusinersen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001448-PIP01-13-M03, Route(s) of administration: Intrathecal use, Pharmaceutical form(s): Solution for injection
Decision date: 11/04/2018, Last updated: 25/07/2018, Compliance check: V, 29/06/2018 -
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Orphan designation: Recombinant human nerve growth factor (cenegermin) for: Treatment of neurotrophic keratitis
Date of designation: 14/12/2015, Positive, Last updated: 02/02/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Oxervate, Cenegermin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-001729-PIP02-18, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 17/04/2019, Last updated: 25/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ofev, nintedanib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001006-PIP02-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 27/10/2015, Last updated: 11/07/2016, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vargatef, nintedanib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001006-PIP03-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 05/05/2017, Last updated: 03/07/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vidaza, azacitidine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001272-PIP02-13-M01, Route(s) of administration: Subcutaneous use, Intravenous use, Pharmaceutical form(s): Powder for suspension for injection, Powder for solution for infusion
Decision date: 02/10/2015, Last updated: 23/11/2015, Compliance check: X -
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Orphan designation: carfilzomib for: Treatment of multiple myeloma
Date of designation: 03/06/2008, Positive, Last updated: 02/12/2015 -
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Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis, carfilzomib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001806-PIP03-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 15/05/2019, Last updated: 29/10/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis, carfilzomib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-001806-PIP04-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 27/01/2021, Last updated: 29/09/2021, Compliance check: X -
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Orphan designation: Recombinant human lysosomal acid lipase for: Treatment of lysosomal acid lipase deficiency
Date of designation: 17/12/2010, Positive, Last updated: 20/11/2019 -
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Orphan designation: Recombinant human tripeptidyl-peptidase 1 for: Treatment of neuronal ceroid lipofuscinosis type 2
Date of designation: 12/03/2013, Positive, Last updated: 09/02/2016 -
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Orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid for: Treatment of progressive familial intrahepatic cholestasis
Date of designation: 17/07/2012, Positive, Last updated: 28/07/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Isentress, Raltegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000279-PIP01-08-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Chewable tablet, Granules for oral suspension
Decision date: 15/06/2016, Last updated: 02/03/2018, Compliance check: V, 19/06/2017 -
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Orphan designation: Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl] (ponatinib) for: Treatment of chronic myeloid leukaemia
Date of designation: 02/02/2010, Positive, Last updated: 23/03/2015 -
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Orphan designation: Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl] (ponatinib) for: Treatment of acute lymphoblastic leukaemia
Date of designation: 02/02/2010, Positive, Last updated: 23/03/2015 -
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Opinion/decision on a Paediatric investigation plan (PIP): Iclusig, ponatinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001186-PIP01-11-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate dosage form, other
Decision date: 12/09/2018, Last updated: 05/02/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco, ivacaftor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000335-PIP01-08-M14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules in sachet
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Orphan designation: Eculizumab for: Treatment of atypical haemolytic uraemic syndrome (aHUS)
Date of designation: 24/07/2009, Positive, Last updated: 20/11/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP05-15-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 29/09/2020, Last updated: 08/07/2021, Compliance check: X