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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-100897-PIP01-23-M02 (update)
  • Nemolizumab
  • Treatment of atopic dermatitis
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Nemluvio
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102238-PIP01-25-M01 (update)
  • ozanimod hydrochloride
  • Treatment of ulcerative colitis
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100654-PIP01-22 -M01 (update)
  • triheptanoin
  • Treatment of long-chain fatty acid oxidation disorders (LC-FAOD)
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Dojolvi
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102316-PIP01-26-M01 (update)
  • ERAVACYCLINE
  • Treatment of complicated intra-abdominal infection
  • Xerava
  • Xerava
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100718-PIP01-22-M03 (update)
  • deucravacitinib
  • Treatment of psoriasis
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102115-PIP01-25
  • Olomorasib
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue neoplasms)
  • Treatment of malignant neoplasms of the central nervous system
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102216-PIP01-25
  • bimekizumab
  • Treatment of Palmoplantar Pustulosis
  • Bimzelx
  • Bimzelx
  • Bimzelx
  • Bimzelx
  • Dermatology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100931-PIP01-23-M05 (update)
  • mirikizumab
  • Treatment of ulcerative colitis. Treatment of Crohn's Disease.
  • Omvoh
  • Omvoh
  • Omvoh
  • Omvoh
  • Omvoh
  • Omvoh
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102188-PIP01-25
  • Tavapadon
  • Treatment of Parkinson’s disease
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102179-PIP01-25
  • aceclidine
  • Treatment of presbyopia
  • VIZZ VIZZ (aceclidine) 14.66 mg/mL eye drops solution
  • VIZZ (aceclidine ophthalmic solution) 1.44%, for topical ophthalmic use
  • Ophthamology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102132-PIP01-25
  • 3-(1-(2-((S)-2-(3-Cyclopropyl-4-fluorophenyl)-3-(3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl)-4-methyl-4,5,6,7-tetrahydro-2H-pyrazolo[4,3-c]pyridine-5-carbonyl)-7-((S)-2,2-dimethyltetrahydro-2Hpyran-4-yl)indolizin-3-yl)cyclopropyl)-1,2,4-oxadiazol-5(4H)-one
  • (AZD5004)
  • Treatment of obesity
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100141-PIP01-21-M02 (update)
  • BENRALIZUMAB
  • Treatment of Eosinophilic granulomatosis with polyangiitis (EGPA)
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA
  • Other: Respiratory, thoracic and mediastinal disorders, Immune system disorders
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100230-PIP01-21 -M03 (update)
  • Nerandomilast
  • Treatment of fibrosing interstitial lung disease
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102136-PIP01-25
  • Human amylin analogue, amylin receptor selective, long-acting, N-terminally lipidated (AZD6234)
  • Treatment of obesity
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100019-PIP01-21-M02 (update)
  • BELUMOSUDIL MESYLATE
  • Treatment of chronic Graft versus Host Disease (cGVHD)
  • Rezurock
  • Rezurock
  • Rholistiq
  • Rholistiq
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Rezurock
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100678-PIP01-22-M02 (update)
  • Vamikibart
  • Treatment of uveitic macular oedema
  • Ophthamology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102273-PIP01-25
  • EZETIMIBE
  • ATORVASTATIN
  • Treatment of hypercholesterolaemia
  • Prevention of cardiovascular events
  • Ezetimibe/Atorvastatin 10mg/10mg Film-coated Tablets
  • Ezetimibe/Atorvastatin 10mg/20mg Film-coated Tablets
  • Ezetimibe/Atorvastatin 10mg/40mg Film-coated Tablets
  • Ezetimibe/Atorvastatin 10mg/80mg Film-coated Tablets
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102153-PIP01-25
  • Human IgG1 monoclonal antibody against folate receptor alfa conjugated to samrotecan
  • Treatment of ovarian cancer, fallopian tube cancer and peritoneal cancer.
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100406-PIP01-21-M03 (update)
  • Marstacimab
  • Treatment of congenital haemophilia A Treatment of congenital haemophilia B
  • Hympavzi 150 mg solution for injection in pre-filled syringe
  • Hympavzi 150 mg solution for injection in pre-filled syringe
  • Hympavzi 150 mg solution for injection in pre-filled syringe
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-102137-PIP01-25
  • izalontamab brengitecan
  • Treatment of lung cancer
  • Treatment of breast cancer
  • Treatment of urothelial carcinoma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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