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Displaying 1 - 20 of 263
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101323-PIP01-23
  • tulisokibart
  • Treatment of ulcerative colitis
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-101323-PIP02-24
  • tulisokibart
  • Treatment of Crohn's disease
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-101097-PIP01-23-M02 (update)
  • Modified Vaccinia Ankara – Bavarian Nordic Live virus
  • Prevention of smallpox, mpox and diseases caused by vaccinia virus
  • Imvanex
  • Imvamune
  • Imvanex
  • Imvanex
  • Jynneos
  • Jynneos
  • Jynneos
  • Jynneos
  • IMVANEX (associated names: JYNNEOS, IMVAMUNE)
  • Infectious diseases
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-102445-PIP01-26-M01 (update)
  • PRETOMANID
  • Treatment of multi-drug-resistant tuberculosis
  • Dovprela
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
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-100999-PIP03-23
  • Ensitrelvir
  • Prevention of coronavirus disease 2019 (COVID-19).
  • Zokovea
  • Xocova
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100469-PIP01-22-M02 (update)
  • delgocitinib
  • Treatment of chronic hand eczema
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101723-PIP01-24-M01 (update)
  • USTEKINUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis and juvenile idiopathic arthritis).
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Selara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100222-PIP01-21-M03 (update)
  • romosozumab
  • Treatment of osteoporosis
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • EVENITY
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100062-PIP01-21-M01 (update)
  • VANZACAFTOR CALCIUM DIHYDRATE
  • TEZACAFTOR
  • DEUTIVACAFTOR
  • Treatment of Cystic Fibrosis
  • alyftrek
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100507-PIP01-22-M03 (update)
  • BREXPIPRAZOLE
  • Treatment of schizophrenia
  • RXULTI
  • RXULTI
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-102324-PIP01-26-M01 (update)
  • CABOZANTINIB
  • Treatment of malignant solid tumours
  • Cabometyx
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-102252-PIP01-25
  • mavorixafor
  • Treatment of WHIM (Warts, Hypogammaglobulinaemia, Infections, and Myelokathexis) syndrome
  • Xolremdi
  • Xolremdi
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100558-PIP01-22-M02 (update)
  • milvexian
  • Prevention of thromboembolism in patients with cardiovascular disease
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100254-PIP01-21-M02 (update)
  • epcoritamab
  • Treatment of mature B-cell lymphoma
  • Tepkinly
  • Tepkinly
  • Tepkinly
  • Tepkinly
  • Tepkinly
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101078-PIP01-23-M03 (update)
  • OLAPARIB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101244-PIP01-23-M01 (update)
  • UPADACITINIB
  • Treatment of vitiligo
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted