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Displaying 101 - 120 of 295
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-101085-PIP01-23
  • Humanised IgG1 monoclonal antibody against integrin beta-6 conjugated to monomethyl auristatin E via a valine-citrulline linker
  • Treatment of non-small cell lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-101100-PIP01-23
  • Derivative of a benzoimidazole substituted pyrimidine (PF-07220060)
  • Treatment of breast malignant neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-101122-PIP01-23
  • ENFORTUMAB VEDOTIN
  • Treatment of head and neck epithelial malignant neoplasms
  • Padcev
  • Padcev
  • Padcev
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-100698-PIP01-22
  • 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
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-101118-PIP01-23
  • 5’-capped mRNA encoding HPV16 oncoprotein E6 5’-capped mRNA encoding HPV16 oncoprotein E7
  • Treatment of head and neck squamous cell carcinoma
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/04/2024
MHRA-100832-PIP01-23-M01 (update)
  • LANADELUMAB
  • Prevention of attacks of idiopathic non-histaminergic angioedema (INHA).
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • Other: Genetic disease
W: decision granting a waiver in all age groups for the listed condition(s). No 24/08/2023
MHRA-100503-PIP01-22
  • efavaleukin alfa
  • Treatment of ulcerative colitis
  • Not available at present
  • Other: Inflammatory Bowel Disease
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
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 24/08/2023
MHRA-100100-PIP01-21
  • Human Immunoglobulin G1 Constant Region – Human Ectodysplasin-A1 Receptor-binding Domain Fusion Protein
  • Treatment of X-linked hypohidrotic ectodermal dysplasia (XLHED)
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100199-PIP01-21
  • efgartigimod alfa
  • Treatment of Pemphigus
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100312-PIP01-21
  • Ritlectinib
  • Treatment of alopecia areata
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 29/07/2022
MHRA-100448-PIP01-22
  • RUXOLITINIB PHOSPHATE
  • Treatment of vitiligo
  • OPZELURA
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100115-PIP01-21
  • Dersimelagon
  • Treatment of erythropoietic protoporphyria
  • Treatment of X-linked protoporphyria
  • Not available at present
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100218-PIP01-21
  • DUPILUMAB
  • Treatment of chronic spontaneous urticaria
  • Dupixent
  • Dupixent
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100469-PIP01-22
  • delgocitinib
  • Treatment of chronic hand eczema
  • no invented name yet
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/02/2023
MHRA-100251-PIP01-21
  • DUPILUMAB
  • Chronic pruritus of unknown origin
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 02/02/2023
MHRA-100508-PIP01-22
  • tezepelumab
  • Treatment of chronic spontaneous urticaria
  • Not available at present
  • TEZSPIRE
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 25/05/2023
MHRA-100371-PIP01-21
  • Ex vivo expanded autologous human keratinocytes containing epidermal stem cells genetically modified with a gamma-retroviral (RV) vector expressing the full-length LAMB3 cDNA
  • Treatment of Junctional Epidermolysis Bullosa (JEB)
  • HOLOGENE 5
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/06/2023
MHRA-100733-PIP01-22
  • Botulinum toxin type E
  • Treatment of skin wrinkling
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
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 24/08/2023