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Displaying 21 - 40 of 139
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101492-PIP01-24
  • Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)
  • Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)
  • Recombinant Influenza Hemagglutinin-strain B (RIV3)
  • Prevention of influenza disease
  • Flublok
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101389-PIP01-24
  • omaveloxolone
  • Treatment of Friedreich's ataxia
  • Skyclarys
  • Skyclarys
  • Other: Neuromuscular
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100343-PIP01-21-M04 (update)
  • MACITENTAN
  • Treatment of pulmonary arterial hypertension
  • Treatment of systemic sclerosis
  • Treatment of idiopathic pulmonary fibrosis
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100991-PIP01-23-M01 (update)
  • Maralixibat chloride
  • Progressive familial intrahepatic cholestasis (PFIC)
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100070-PIP01-21-M01 (update)
  • molnupiravir
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Lagevrio
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100218-PIP01-21-M01 (update)
  • DUPILUMAB
  • Chronic spontaneous urticaria
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100654-PIP01-22
  • triheptanoin
  • Treatment of long-chain fatty acid oxidation disorders (LC-FAOD)
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100754-PIP01-22-M01 (update)
  • Live-attenuated La Reunion strain of chikungunya virus
  • Prevention of chikungunya virus disease
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101352-PIP01-24-M01 (update)
  • Autologous tumour-infiltrating lymphocytes (LN-144/LN-145)
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • AMTAGVI
  • AMTAGVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101107-PIP01-23-M01 (update)
  • BIRCH BARK EXTRACT
  • Treatment of epidermolysis bullosa
  • Filsuvez
  • Filsuvez gel
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100469-PIP01-22-M02 (update)
  • delgocitinib
  • Treatment of chronic hand eczema
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101268-PIP01-23
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H5N1
  • Prevention of pandemic influenza
  • Incellipan
  • Audenz
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-101269-PIP01-23
  • Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen
  • Prevention of zoonotic influenza
  • Celldemic
  • Audenz
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101394-PIP01-24
  • clascoterone
  • Treatment of acne vulgaris
  • Winlevi 10 mg/g cream
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101392-PIP01-24
  • Influenza Virus Type A, H1N1
  • Influenza Virus Type A, H3N2
  • Influenza Virus Type B, Victoria lineage
  • Prevention of influenza infection
  • Fluenz
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-100089-PIP01-21-M02 (update)
  • DUPILUMAB
  • Treatment of eosinophilic oesophagitis
  • Dupixent
  • Dupixent
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101162-PIP01-23-M01 (update)
  • LETERMOVIR
  • Prevention of cytomegalovirus infection
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PRVEYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • tablet
  • PREVYMIS
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100240-PIP01-21-M04 (update)
  • BOSUTINIB
  • Treatment of chronic myeloid leukemia
  • Bosulif
  • Bosulif
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100343-PIP01-21-M03 (update)
  • MACITENTAN
  • Treatment of pulmonary arterial hypertension
  • Treatment of systemic sclerosis
  • Treatment of idiopathic pulmonary fibrosis.
  • Opsumit
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101234-PIP01-23-M01 (update)
  • ALIROCUMAB
  • Treatment of elevated cholesterol
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted