Displaying 121 - 140 of 1085
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100351-PIP01-21-M04 (update)
  • DOLUTEGRAVIR
  • RILPIVIRINE
  • Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.
  • JULUCA
  • JULUCA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102313-PIP01-26
  • Lorecivivint
  • Treatment of osteoarthritis of the knee and hip
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102302-PIP01-26
  • mRNA encoding Influenza A, subtype H5N1, strain A/chicken/Ghana/2021, haemagglutinin
  • Prevention of pandemic influenza
  • Vaccines
  • Other: mRNA vaccine
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102181-PIP01-25
  • Tinlarebant
  • Treatment of Stargardt disease
  • Ophthamology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-101669-PIP01-24
  • Zerlasiran
  • Prevention of cardiovascular events
  • zerlasiran
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102311-PIP01-26
  • EYE103 / MK-3000
  • Treatment of diabetic macular oedema
  • Not available at present
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102154-PIP01-25
  • AMIVANTAMAB
  • Head and neck epithelial malignant neoplasms
  • Rybrevant
  • Rybrevant
  • Rybrevant
  • Rybrevant
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101250-PIP01-23-M02 (update)
  • RISANKIZUMAB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondylarthritis and juvenile idiopathic arthritis).
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Skyrizi
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102219-PIP01-25
  • MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
  • Treatment of VEXAS syndrome in adults.
  • Omjjara
  • Omjjara 100mg film-coated tablets (PLGB 19494/0318)
  • Omjjara 150mg film-coated tablets (PLGB 19494/0322)
  • Omjjara 200mg film-coated tablets (PLGB 19494/0323)
  • Ojjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • OJJAARA
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Ojjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Other: hemato-inflammatory condition
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101388-PIP01-24-M06 (update)
  • DARIDOREXANT HYDROCHLORIDE
  • Treatment of insomnia
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • QUVIVIQ
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101692-PIP01-24-M02 (update)
  • Atogepant
  • atogepant
  • Prevention of migraine headaches
  • Aquipta
  • Aquipta
  • Aquipta
  • Aquipta
  • Aquipta
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102261-PIP01-25
  • Human IgG1 kappa monoclonal antibody against TREM2
  • Treatment of Amyotrophic lateral sclerosis
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102123-PIP01-25
  • Gocatamig
  • Treatment of small cell lung cancer (SCLC)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100623-PIP01-22-M03 (update)
  • NIRAPARIB TOSYLATE MONOHYDRATE
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoetic and lymphoid malignancies)
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100618-PIP01-22-M01 (update)
  • AVIBACTAM
  • CEFTAZIDIME
  • Treatment of intra-abdominal infections
  • Treatment of urinary tract infections
  • Treatment of pneumonia
  • Treatment of infections due aerobic Gram-negative organisms.
  • Zavicefta
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100614-PIP01-22-M03 (update)
  • VONICOG ALFA
  • Treatment of von Willebrand Disease
  • veyvondi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100610-PIP01-22-M01 (update)
  • ECULIZUMAB
  • Treatment of myasthenia gravis
  • SOLIRIS
  • SOLIRIS
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100609-PIP01-22-M01 (update)
  • LENVATINIB MESILATE
  • Treatment of papillary thyroid cancer and follicular thyroid cancer
  • Treatment of osteosarcoma
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Lenvima
  • Kisplyx
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100604-PIP01-22-M02 (update)
  • REMDESIVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • VEKLURY
  • VEKLURY
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100586-PIP01-22-M02 (update)
  • DUPILUMAB
  • Treatment of asthma
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted