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Displaying 601 - 620 of 797
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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
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
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
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
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
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
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
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
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
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
MHRA-100274-PIP01-21-M01 (update)
  • ELIGLUSTAT
  • Treatment of Gaucher Disease type 2
  • Treatment of Gaucher Disease Type 1 and Type 3
  • CERDELGA
  • Other: Lysosomal Storage Disorder
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100637-PIP01-22
  • Mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNA oligonucleotides that are directed against hepatitis B virus
  • Treatment of chronic hepatitis D infection
  • Not available at present
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100545-PIP01-22
  • Lutetium (177Lu) edotreotide
  • Treatment of gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs)
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100316-PIP02-22
  • latozinemab
  • Treatment of Amyotrophic lateral sclerosis
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100186-PIP01-21
  • depemokimab
  • Treatment of chronic rhinosinusitus with nasal polyps (CRSwNP)
  • Depemokimab
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100559-PIP01-22
  • mitapivat
  • Treatment of thalassaemia
  • PYRUKYND
  • PYRUKYND
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100628-PIP01-22
  • Sibeprenlimab
  • Treatment of primary immunoglobulin A nephropathy
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100588-PIP01-22
  • UB-612
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available at present
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100345-PIP01-21
  • Magrolimab
  • Treatment of myelodysplastic syndromes (including juvenile myelomonocytic leukaemia)
  • Treatment of acute myeloid leukaemia
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100508-PIP01-22
  • tezepelumab
  • Treatment of chronic spontaneous urticaria
  • Not available at present
  • TEZSPIRE
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No