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Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene for: Treatment of beta thalassaemia intermedia and major
Date of first decision: 24/01/2013, Positive, Last updated: 03/06/2019 -
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Orphan designation: Brentuximab vedotin for: Treatment of cutaneous T-cell lymphoma
Date of first decision: 11/01/2012, Positive, Last updated: 26/08/2020 -
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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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Orphan designation: (R)-2-Methyl-6-nitro-2-{4-[4-(4-trifluoromethoxyphenoxy)piperidin-1-yl]phenoxymethyl}-2,3-dihydroimidazo[2,1-b]oxazole (delamanid) for: Treatment of tuberculosis
Date of first decision: 02/02/2008, Positive, Last updated: 18/06/2014 -
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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): Holoclar, Ex-vivo expanded human autologous epithelium containing stem cells
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-001082-PIP02-11-M02, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Living tissue equivalent
Decision date: 07/12/2018, Last updated: 18/02/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Crysvita, Burosumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001659-PIP01-15-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/03/2020, Last updated: 04/08/2020, Compliance check: X -
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Orphan designation: (1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol bedaquiline for: Treatment of tuberculosis
Date of first decision: 26/08/2005, Positive, Last updated: 01/04/2014 -
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Opinion/decision on a Paediatric investigation plan (PIP): Natpar, Recombinant parathyroid hormone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001526-PIP01-13-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 17/04/2019, Last updated: 24/06/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Deltyba, Delamanid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001113-PIP01-10-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 14/08/2019, Last updated: 20/11/2019, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro, Ixazomib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001410-PIP02-17-M02, Route(s) of administration: Intravenous use, Oral use, Gastric use, Pharmaceutical form(s): Powder for solution for injection, Capsule, hard
Decision date: 16/07/2019, Last updated: 14/11/2019, Compliance check: X -
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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: 24/06/2019, Compliance check: X -
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Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase) for: Prevention of graft rejection following solid organ transplantation
Date of first decision: 12/01/2017, Positive, Last updated: 28/08/2020 -
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Orphan designation: 6alpha-ethyl-chenodeoxycholic acid for: Treatment of primary biliary cirrhosis
Date of first decision: 27/07/2010, Positive, Last updated: 19/12/2016 -
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Opinion/decision on a Paediatric investigation plan (PIP): Caprelsa, Vandetanib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000052-PIP01-07-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 30/11/2013, Last updated: 06/01/2014, Compliance check: V, 20/06/2014 -
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Orphan designation: Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide, (L)-malate salt (cabozantinib) for: Treatment of medullary thyroid carcinoma
Date of first decision: 06/02/2009, Positive, Last updated: 12/05/2014 -
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Orphan designation: Humanised monoclonal antibody targeting B-cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F for: Treatment of multiple myeloma
Date of first decision: 16/10/2017, Positive, Last updated: 17/09/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Pixuvri, pixantrone dimaleate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000713-PIP02-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 20/07/2018, Last updated: 28/11/2018, Compliance check: X -
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Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E (brentuximab vedotin) for: Adjunctive treatment in haematopoietic cell transplantation
Date of first decision: 15/01/2009, Positive, Last updated: 26/08/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Translarna, Ataluren
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000115-PIP01-07-M10, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 11/09/2019, Last updated: 26/03/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Humenza, Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000669-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for injection
Decision date: 04/01/2019, Last updated: 16/04/2019, Compliance check: X -
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Orphan designation: 2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid for: Treatment of multiple myeloma
Date of first decision: 27/09/2011, Positive, Last updated: 26/08/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP01-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 11/08/2017, Last updated: 02/10/2017, Compliance check: X -
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Orphan designation: polatuzumab vedotin for: Treatment of diffuse large B-cell lymphoma
Date of first decision: 16/04/2018, Positive, Last updated: 27/01/2020 -
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Orphan designation: (S)-2-nitro-6-(4-trifluoromethoxy)benzyloxy)-6,7-dihydro-5H-imidazo[2,1-b] [1,3] oxazine (pretomanid) for: Treatment of tuberculosis
Date of first decision: 29/11/2007, Positive, Last updated: 08/02/2016