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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-100147-PIP01-21-M01 (update)
  • OSELTAMIVIR PHOSPHATE
  • Treatment and prevention of influenza
  • Tamiflu
  • Tamiflu
  • Tamiflu
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100107-PIP01-21
  • 1-(3-methylbutanoyl)-l-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-(l-cystinyl-l-isoleucyl-[(n6-(s)-4-carboxy-4-palmitamidobutanoyl)-l-lysinyl]-l-phenylalanyl-l-glutamyl-l-prolyl-l-arginyl-l-serinyl-l-lysinyl-l-glycinyl-l-cystinyl)-l-lysinamide, disulfide, acetate
  • Treatment of polycythaemia vera
  • Haematology-Hemostaseology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100090-PIP01-21-M01 (update)
  • DUPILUMAB
  • Treatment of atopic dermatitis
  • Dupixent
  • Dupixent
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100112-PIP01-21
  • savolitinib
  • Treatment of renal neoplasms
  • Not available
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100072-PIP01-21-M01 (update)
  • COVID-19 Vaccine (ChAdOx1-S [recombinant])
  • Prevention of coronavirus disease 2019 (COVID-19)
  • COVID-19 Vaccine AstraZeneca
  • COVID-19 Vaccine AstraZeneca
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100076-PIP01-21-M01 (update)
  • TENOFOVIR DISOPROXIL FUMARATE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Treatment of chronic viral hepatitis B
  • Viread
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100054-PIP01-21
  • RO7496998 (AT-527)
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Not available at present
  • Infectious diseases
  • Other: Pandemic
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100060-PIP01-21
  • 2'-O-(2-methoxyethyl) phosphorothioate antisense oligonucleotide targeting CD49d RNA
  • Treatment of Duchenne muscular dystrophy
  • Other: Neuromuscular
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100057-PIP01-21
  • BENRALIZUMAB
  • Treatment of eosinophilic oesophagitis
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • Gastroenterology-Hepatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100056-PIP01-21
  • BENRALIZUMAB
  • Eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE)
  • FASENRA
  • FASENRA
  • FASENRA
  • Gastroenterology-Hepatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100048-PIP01-21
  • Afamitresgene autoleucel
  • Treatment of soft tissue sarcoma
  • Not available at present.
  • Oncology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100080-PIP01-21
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
  • Treatment of Immune Thrombocytopenic Purpura
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100160-PIP01-21-M01 (update)
  • TOCILIZUMAB
  • Cytokine release syndrome due to (CAR) T cell therapy or T-cell- bispecific antibody therapy
  • RoActemra
  • RoActemra
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100154-PIP01-21-M01 (update)
  • Cotadutide
  • Treatment of Type 2 Diabetes Mellitus
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100142-PIP01-21
  • Synthetic Hypericin
  • Treatment of cutaneous T-cell lymphoma
  • HyBryte
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100131-PIP01-21
  • ATEZOLIZUMAB
  • Treatment of all malignant neoplasms (except CNS tumours, haematopoietic, lymphoid neoplasms)
  • Tecentriq
  • Tecentriq
  • Tecentriq
  • Tecentriq
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100097-PIP01-21-M01 (update)
  • eladocagene exuparvovec
  • Treatment of Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency
  • Upstaza
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100081-PIP01-21
  • Zibotentan
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
  • Treatment of Chronic Kidney Disease
  • Not available at present
  • Other: Renal Disease
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100074-PIP01-21
  • GABAPENTIN
  • Treatment of Postherpetic Neuralgia
  • Gralise
  • Neurology
  • Pain
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100040-PIP01-21-M01 (update)
  • Cotadutide
  • Treatment of Type 2 Diabetes Mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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