For help on how to get the results you want, see our search tips.
1918 results
Categories
Human Remove Human filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 4 - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 5 - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 6A- diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 6B - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 7F - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 9V - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 14 - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 18C - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 19A - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 19F - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 22F - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 23F - diphtheria CRM197 conjugate, pneumococcal polysaccharide serotype 33F – diphtheria CRM197 conjugate (15-valent pneumococcal polysaccharide conjugate vaccine [V114]) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: EMEA-002215-PIP01-17-M02, decision date: 17/07/2019, Last updated: 19/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tremelimumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-002029-PIP01-16-M01, decision date: 17/07/2019, Last updated: 19/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Imfinzi, durvalumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-002028-PIP01-16-M01, decision date: 16/07/2019, Last updated: 19/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto, Venetoclax (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: EMEA-002018-PIP02-16-M02, decision date: 17/07/2019, Last updated: 18/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Balovaptan (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: EMEA-001918-PIP01-15-M02, decision date: 16/07/2019, Last updated: 18/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, Lanadelumab (DX-2930) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: EMEA-001864-PIP01-15-M04, decision date: 23/07/2019, Last updated: 18/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Emgality, Galcanezumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: EMEA-001860-PIP03-16-M03, decision date: 16/07/2019, Last updated: 18/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: EMEA-001853-PIP01-15-M02, decision date: 18/11/2019, Last updated: 18/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide (VX-661), ivacaftor (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pneumology-allergology, PIP number: EMEA-001640-PIP01-14-M05, decision date: 17/07/2019, Last updated: 18/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): tezepelumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pneumology-allergology, PIP number: EMEA-001613-PIP01-14-M03, decision date: 19/07/2019, Last updated: 18/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Giotrif, afatinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-001596-PIP02-17-M01, decision date: 16/07/2019, Last updated: 18/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Xerava, eravacycline (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-001555-PIP01-13-M03, decision date: 16/07/2019, Last updated: 18/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Testosterone (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrinology, -gynacology-fertility-metabolism, PIP number: EMEA-001529-PIP02-14-M02, decision date: 16/07/2019, Last updated: 14/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Fentanyl (hydrochloride) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pain, PIP number: EMEA-001509-PIP01-13-M02, decision date: 16/07/2019, Last updated: 14/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Esketamine (hydrochloride) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Psychiatry, PIP number: EMEA-001428-PIP03-15-M01, decision date: 16/07/2019, Last updated: 14/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro, Ixazomib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: EMEA-001410-PIP02-17-M02, decision date: 16/07/2019, Last updated: 14/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Sivextro, Tedizolid (phosphate) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: EMEA-001379-PIP01-12-M04, decision date: 05/07/2019, Last updated: 14/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, baricitinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Dermatology, PIP number: EMEA-001220-PIP03-16-M01, decision date: 16/07/2019, Last updated: 14/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Akynzeo, Fosnetupitant, Palonosetron (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: EMEA-001198-PIP03-17-M02, decision date: 25/07/2019, Last updated: 14/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: EMEA-000876-PIP03-14-M03, decision date: 16/07/2019, Last updated: 14/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus and Dermatophagoides farinae extracts 50% / 50% (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pneumology-allergology, PIP number: EMEA-000815-PIP01-09-M01, decision date: 05/07/2019, Last updated: 14/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Birch, hazel and alder pollen extracts (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pneumology-allergology, PIP number: EMEA-000808-PIP01-09-M01, decision date: 05/07/2019, Last updated: 14/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): RoActemra, tocilizumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: EMEA-000309-PIP04-17-M02, decision date: 16/07/2019, Last updated: 13/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Nulojix, belatacept (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: EMEA-000157-PIP01-07-M04, decision date: 16/07/2019, Last updated: 13/11/2019, compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): NexoBrid, Concentrate of proteolytic enzymes in bromelain (updated)
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Other, PIP number: EMEA-000142-PIP02-09-M08, decision date: 16/07/2019, Last updated: 13/11/2019, compliance check: X