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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
PIP Number MHRA-100094-PIP01-21-M02 (update) Active Substance
  • DORAVIRINE
  • LAMIVUDINE
  • TENOFOVIR DISOPROXIL FUMARATE
 Conditions / Indications
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection
 Invented Name
  • Delstrigo
 Therapeutic area
  • Infectious diseases
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100786-PIP01-22-M01 (update) Active Substance
  • TOFACITINIB CITRATE
 Conditions / Indications
  • Treatment of ulcerative colitis
 Invented Name
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
 Therapeutic area
  • Gastroenterology-Hepatology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100832-PIP01-23-M01 (update) Active Substance
  • LANADELUMAB
 Conditions / Indications
  • Prevention of attacks of idiopathic non-histaminergic angioedema (INHA).
 Invented Name
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
  • TAKHZYRO
 Therapeutic area
  • Other: Genetic disease
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100212-PIP01-21-M02 (update) Active Substance
  • FINERENONE
 Conditions / Indications
  • Treatment of Chronic Kidney Disease
 Invented Name
  • Kerendia
  • Kerendia
 Therapeutic area
  • Uro-Nephrology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100776-PIP01-22-M01 (update) Active Substance
  • Nemolizumab
 Conditions / Indications
  • Treatment of atopic dermatitis.
 Invented Name
  • Not yet defined
 Therapeutic area
  • Dermatology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100676-PIP01-22-M01 (update) Active Substance
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE FUMARATE
 Conditions / Indications
  • Treatment of human immunodeficiency virus (HIV-1) infection.
 Invented Name
  • Descovy
  • Descovy
 Therapeutic area
  • Infectious diseases
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100801-PIP01-22 Active Substance
  • eplontersen
 Conditions / Indications
  • Treatment of transthyretin-mediated amyloidosis
 Invented Name
  • Not available at present
 Therapeutic area
  • Neurology
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100806-PIP01-22 Active Substance
  • ALPELISIB
 Conditions / Indications
  • Treatment of ovarian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Fallopian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Peritoneal cancer (excluding blastomas and sarcomas).
Invented Name
  • Piqray
  • Piqray
 Therapeutic area
  • Oncology
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100301-PIP02-22 Active Substance
  • Nipocalimab
 Conditions / Indications
  • Treatment of Bullous Pemphigoid
 Invented Name Therapeutic area
  • Dermatology
 Decision Type W: decision granting a waiver in all age groups for the listed condition(s). Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100677-PIP01-22-M01 (update) Active Substance
  • COBICISTAT
 Conditions / Indications
  • Treatment of human immunodeficiency virus type-1 (HIV-1) infection
Invented Name
  • Tybost
  • Tybost
 Therapeutic area
  • Infectious diseases
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100778-PIP01-22-M01 (update) Active Substance
  • GUSELKUMAB
 Conditions / Indications
  • Treatment of ulcerative colitis
 Invented Name
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
 Therapeutic area
  • Gastroenterology-Hepatology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100690-PIP01-22-M01 (update) Active Substance
  • IMIPENEM MONOHYDRATE
  • CILASTATIN SODIUM
  • RELEBACTAM MONOHYDRATE
 Conditions / Indications
  • Treatment of infections caused by gram-negative organisms.
Invented Name
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
 Therapeutic area
  • Infectious diseases
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100330-PIP01-21 -M01 (update) Active Substance
  • Autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) genetically modified with the lentiviral vector IDUA LVV, encoding for the human α-L-iduronidase (IDUA) gene (OTL-203)
 Conditions / Indications
  • Treatment of Mucopolysaccharidosis type I, Hurler syndrome (MPS-IH)
Invented Name
  • Not available at present
 Therapeutic area
  • Other: Metabolic disorders
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100268-PIP01-21-M03 (update) Active Substance
  • INOTUZUMAB OZOGAMICIN
 Conditions / Indications
  • Treatment of B cell acute lymphoblastic leukaemia
 Invented Name
  • Besponsa
  • Besponsa
 Therapeutic area
  • Haematology-Hemostaseology
  • Oncology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100268-PIP01-21-M02 (update) Active Substance
  • INOTUZUMAB OZOGAMICIN
 Conditions / Indications
  • Treatment of B cell acute lymphoblastic leukaemia
 Invented Name
  • Besponsa
  • Besponsa
 Therapeutic area
  • Oncology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100750-PIP01-22-M01 (update) Active Substance
  • setrusumab
 Conditions / Indications
  • Treatment of osteogenesis imperfecta
 Invented Name Therapeutic area
  • Other: Skeletal
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100276-PIP01-21-M02 (update) Active Substance
  • BRODALUMAB
 Conditions / Indications
  • Treatment of psoriasis
 Invented Name
  • Kyntheum
  • Lumicef
  • Siliq
 Therapeutic area
  • Dermatology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100807-PIP01-22-M01 (update) Active Substance
  • RIMEGEPANT SULFATE
 Conditions / Indications
  • Treatment of migraine headaches
 Invented Name
  • Vydura
 Therapeutic area
  • Neurology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100687-PIP01-22-M01 (update) Active Substance
  • OBINUTUZUMAB
 Conditions / Indications
  • Treatment of systemic lupus erythematosus
 Invented Name
  • Gazyvaro
  • Gazyvaro
 Therapeutic area
  • Oncology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
PIP Number MHRA-100297-PIP01-21-M01 (update) Active Substance
  • Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (rocatinlimab)
Conditions / Indications
  • Treatment of atopic dermatitis
 Invented Name Therapeutic area
  • Dermatology
 Decision Type PM: decision on the application for modification of an agreed paediatric investigation plan. Compliance Check No Compliance outcome Date Published
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