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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100823-PIP01-22-M03 (update)
  • Recombinant Human A Disintegrin and Metalloprotease with Thrombospondin Type-1 Motifs 13 (rADAMTS13)
  • Treatment of thrombotic thrombocytopenic purpura
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100698-PIP01-22-M01 (update)
  • nemvaleukin alfa
  • Treatment of all conditions included in the category of malignant neoplasms (except CNS, haematopoietic and lymphoid tissue)
  • Treatment of malignant neoplasms of the lymphoid tissue
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100105-PIP01-21-M02 (update)
  • ALPRAZOLAM
  • Treatment of epileptic seizures
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101542-PIP01-24
  • lutikizumab
  • Treatment of hidradenitis suppurativa
  • Dermatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100050-PIP01-21-M02 (update)
  • efgartigimod alfa
  • Treatment of Immune thrombocytopenia
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Vyvgart
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101595-PIP01-24
  • efinopegdutide
  • Treatment of metabolic dysfunction-associated steatohepatitis
  • Gastroenterology-Hepatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101488-PIP01-24
  • etavopivat
  • Treatment of sickle cell disease
  • Not available at present
  • Haematology-Hemostaseology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101664-PIP01-24
  • SECUKINUMAB
  • Treatment of polymyalgia rheumatica
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Immunology -Rheumatology-Transplantation
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101654-PIP01-24
  • Volrustomig
  • Treatment of head and neck epithelial malignant neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101605-PIP01-24
  • Telisotuzumab adizutecan
  • Treatment of lung carcinoma (small cell and non-small cell carcinoma)
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101702-PIP01-24
  • Modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens V940 (mRNA-4157)
  • Treatment of melanoma
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101457-PIP01-24
  • Acasunlimab
  • Treatment of lung cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101435-PIP01-24
  • Hemopexin, human
  • Treatment of sickle cell disease
  • Haematology-Hemostaseology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101314-PIP01-23
  • Venglustat
  • Treatment of Gaucher Disease Type 2
  • Treatment of Gaucher Disease type 3
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100468-PIP01-22-M03 (update)
  • EPTINEZUMAB
  • Prevention of migraine headaches
  • Vyepti
  • VYEPTI 100 mg concent rate for solution for infusion
  • VYEPTI 300 mg concent rate for solution for infusion
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100200-PIP01-21-M02 (update)
  • REGORAFENIB
  • Treatment of all conditions contained in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Stivarga
  • Stivarga
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101767-PIP01-24-M01 (update)
  • TOFACITINIB CITRATE
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis).
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101746-PIP01-24
  • H-(D)p-Benzoylphenylalanyl-(D)seryl-(D)tryptophanyl-(D)seryl-(D)pentafluorophenylalanyl-(D)cyclohexylalanyl-(D)arginyl-(D)arginyl-(D)arginyl-(D)glutaminyl-(D)arginyl-(D)arginine acetate salt
  • Treatment of pancreatic cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100440-PIP01-22-M03 (update)
  • EMTRICITABINE
  • BICTEGRAVIR
  • TENOFOVIR ALAFENAMIDE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Biktarvy
  • Biktarvy
  • Biktarvy
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101773-PIP01-24-M01 (update)
  • Tabelecleucel
  • Treatment of Epstein-Barr virus associated post-transplant lymphoproliferative disorder.
  • Ebvallo
  • Ebvallo
  • Ebvallo
  • Ebvallo
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
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