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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-100776-PIP01-22-M01 (update)
  • Nemolizumab
  • Treatment of atopic dermatitis.
  • Not yet defined
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100801-PIP01-22
  • eplontersen
  • Treatment of transthyretin-mediated amyloidosis
  • Not available at present
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100806-PIP01-22
  • ALPELISIB
  • Treatment of ovarian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Fallopian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Peritoneal cancer (excluding blastomas and sarcomas).
  • Piqray
  • Piqray
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100301-PIP02-22
  • Nipocalimab
  • Treatment of Bullous Pemphigoid
  • Dermatology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100778-PIP01-22-M01 (update)
  • GUSELKUMAB
  • Treatment of ulcerative colitis
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100332-PIP01-21-M01 (update)
  • sotatercept
  • Treatment of pulmonary arterial hypertension
  • Not available at present
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100844-PIP01-23-M01 (update)
  • IVACAFTOR
  • Treatment of cystic fibrosis.
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Kalydeco
  • Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100750-PIP01-22-M01 (update)
  • setrusumab
  • Treatment of osteogenesis imperfecta
  • Other: Skeletal
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100177-PIP01-21-M02 (update)
  • INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN
  • INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN
  • INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN
  • INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN
  • Prevention of Influenza
  • FLUCELVAX TETRA
  • Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe
  • FLUCELVAX TETRA
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100687-PIP01-22-M01 (update)
  • OBINUTUZUMAB
  • Treatment of systemic lupus erythematosus
  • Gazyvaro
  • Gazyvaro
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100824-PIP01-22
  • perflubutane
  • Diagnostic evaluation of focal hepatic lesions
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Sonazoid
  • Diagnostic
  • Oncology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100738-PIP01-22
  • PEMIGATINIB
  • Treatment of myeloid/lymphoid neoplasms with eosinophilia and gene rearrangement
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Pemazyre
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100820-PIP01-22
  • Tirzepatide
  • Treatment of obesity
  • Mounjaro
  • Other: Obesity, Overweight
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100430-PIP01-22
  • ±3,4-methylenedioxymethamphetamine hydrochloride (MDMA)
  • Treatment of post-traumatic stress disorder
  • Not available at present
  • Psychiatry
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100612-PIP01-22
  • Fosmanogepix
  • Treatment of invasive fungal infections
  • Infectious diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100118-PIP02-22
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100788-PIP01-22
  • favezelimab
  • PEMBROLIZUMAB
  • Treatment of Hodgkin lymphoma
  • Not availble at present
  • Oncology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100513-PIP01-22
  • efgartigimod alfa
  • Treatment of dermatomyositis
  • Treatment of immune-mediated necrotizing myopathy
  • Treatment of polymyositis (including antisynthetase syndrome)
  • Immunology -Rheumatology-Transplantation
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100721-PIP01-22
  • Recombinant fusion protein linking iduronate 2-sulfatase to engineered Fc with binding site for transferrin receptor (DNL310)
  • Treatment of mucopolysaccharidosis II (Hunter syndrome)
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100641-PIP01-22-M02 (update)
  • DURVALUMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue)
  • IMFINZI
  • IMFINZI
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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