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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-102443-PIP01-26
  • Telisotuzumab adizutecan
  • Treatment of pancreatic cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100678-PIP01-22-M03 (update)
  • vamikibart
  • Treatment of uveitic macular oedema
  • Ophthamology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101352-PIP01-24-M02 (update)
  • Lifileucal
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • AMTAGVI
  • AMTAGVI
  • AMTAGVI
  • AMTAGVI
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102356-PIP01-26
  • TACROLIMUS MONOHYDRATE
  • Treatment of vernal keratoconjunctivitis
  • Not available at present
  • Ophthamology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101488-PIP01-24-M02 (update)
  • Etavopivat
  • Treatment of sickle cell disease
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-102342-PIP01-26
  • Sepiapterin
  • Treatment of hyperphenylalaninaemia
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-101008-PIP01-23-M02 (update)
  • AMBRISENTAN
  • Treatment of pulmonary arterial hypertension.
  • Volibris
  • Volibris
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-102514-PIP01-26-M01 (update)
  • Concentrate of proteolytic enzyme enriched in in bromelain
  • Treatment of burns.
  • Nexobrid
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101027-PIP01-23-M02 (update)
  • ANIFROLUMAB
  • Treatment of systemic lupus erythematosus
  • Saphnelo 300 mg concentrate for solution for infusion
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102558-PIP01-26
  • Brepocitinib
  • Treatment of Idiopathic inflammatory myopathies
  • 30 mg film-coated tablets
  • Immunology -Rheumatology-Transplantation
  • Dermatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100224-PIP01-21-M04 (update)
  • Etrasimod L-arginine
  • Treatment of ulcerative colitis
  • Velsipity
  • Velsipity
  • Velsipity
  • Velsipity
  • Velsipity
  • Velsipity
  • Velsipity
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102573-PIP01-26
  • BENZOYL PEROXIDE, HYDROUS
  • Treatment of rosacea.
  • Epsolay
  • Dermatology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100996-PIP01-23-M01 (update)
  • Maridebart cafraglutide
  • Treatment of obesity
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101314-PIP01-23-M01 (update)
  • Venglustat
  • Treatment of Gaucher disease type 3
  • Treatment of Gaucher Disease Type 2
  • Infilbray
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102528-PIP01-26
  • Humanised IgG1 monoclonal antibody against microtubule-associated protein tau MK-2214
  • Treatment of Alzheimer's disease
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101469-PIP01-24-M01 (update)
  • Garetosmab
  • Treatment of fibrodysplasia ossificans progressiva (FOP)
  • Pasatru
  • Other: Musculoskeletal
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100817-PIP01-22-M02 (update)
  • SIPONIMOD
  • Treatment of Multiple Sclerosis
  • Mayzent
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101579-PIP01-24-M01 (update)
  • LAROPROVSTAT
  • Treatment of elevated cholesterol
  • Treatment of mixed dyslipidemia
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100137-PIP01-21-M04 (update)
  • linaclotide
  • Treatment of functional constipation
  • Constella
  • Constella
  • Constella
  • Constella
  • Constella
  • Constella
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100209-PIP01-21-M03 (update)
  • survodutide
  • Treatment of obesity
  • Not available at present
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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