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Displaying 221 - 240 of 599
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100627-PIP01-22-M01 (update)
  • Liposomal ciclosporin A (L-CsA)
  • Treatment of bronchiolitis obliterans syndrome (BOS)
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100586-PIP01-22-M01 (update)
  • DUPILUMAB
  • Treatment of asthma
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100240-PIP01-21-M02 (update)
  • BOSUTINIB
  • Treatment of chronic myeloid leukaemia (CML)
  • Bosulif
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100170-PIP01-21-M02 (update)
  • CANAGLIFLOZIN HEMIHYDRATE
  • Treatment of Type 2 Diabetes Mellitus
  • Invokana
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100128-PIP01-21-M02 (update)
  • tiomolibdic acid
  • Wilson disease
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100632-PIP01-22-M01 (update)
  • FLUCICLOVINE (18F)
  • Diagnosis of amino acid metabolism in solid malignant tumours
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Axumin
  • Diagnostic
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
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. No 25/05/2023
MHRA-100761-PIP01-22-M01 (update)
  • NIVOLUMAB
  • relatlimab
  • Treatment of melanoma
  • Opdualag
  • Opdualag
  • Opdualag
  • Opdualag
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100543-PIP01-22-M01 (update)
  • LAMIVUDINE
  • DOLUTEGRAVIR
  • Treatment of Human Immunodeficiency virus type 1 (HIV - 1) Infection
  • Dovato
  • Dovato
  • Dovato
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100571-PIP01-22-M01 (update)
  • TENOFOVIR DISOPROXIL FUMARATE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Treatment of chronic viral hepatitis B
  • Viread
  • Viread
  • Viread
  • Viread
  • Viread
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100340-PIP01-21-M02 (update)
  • LANADELUMAB
  • Prevention of hereditary angioedema attacks
  • TAKHZYRO
  • TAKZHYRO
  • TAKZHRYO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKZHYRO
  • 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
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100078-PIP01-21-M03 (update)
  • AZTREONAM
  • AVIBACTAM
  • Treatment of infections caused by aerobic gram-negative bacteria
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100532-PIP01-22-M02 (update)
  • BUROSUMAB
  • Treatment of X-linked Hypophosphataemia
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Crysvita
  • Other: musculoskeletal disorder; osteology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100517-PIP01-22-M01 (update)
  • APREMILAST
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Otezla
  • Otezla
  • Otezla
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100392-PIP01-21-M02 (update)
  • TOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100518-PIP01-22-M01 (update)
  • APREMILAST
  • Treatment of Behçet’s Disease
  • Otezla
  • Otezla
  • Otezla
  • Otezla
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100505-PIP01-22-M01 (update)
  • copanlisib dihydrochloride
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Treatment of mature B-cell neoplasms
  • Aliqopa
  • Aliqopa
  • Aliqopa
  • Aliqopa
  • Aliqopa
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100116-PIP01-21-M02 (update)
  • IVACAFTOR
  • TEZACAFTOR
  • ELEXACAFTOR
  • Treatment of cystic fibrosis
  • Kaftrio
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Kaftrio
  • Kaftrio
  • Trikafta
  • Trikafta
  • Trikafta
  • Trikafta
  • Kaftrio
  • Pneumology - Allergology
  • Other: Congenital, hereditary and neonatal diseases and abnormalities
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100485-PIP01-22-M01 (update)
  • AMG 176 (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl-3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4f][1,2,7]thiadiazacyclohexadecine-4,1'-naphthalen]-18(17H)-one 16,16-dioxide
  • Treatment of acute myeloid leukaemia
  • Tapotoclax
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100463-PIP01-22-M01 (update)
  • spesolimab
  • Treatment of Generalised Pustular Psoriasis
  • Prevention of Generalised Pustular Psoriasis
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023