Displaying 221 - 240 of 773
PIPS Search Results
PIP Number Active Substance Sort ascending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100731-PIP01-22
  • deucravacitinib
  • Treatment of systemic lupus erythematosus
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100957-PIP01-23
  • deucravacitinib
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis,psoriatic arthritis, ankylosing spondylitis & juvenile idiopathic arthritis)
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 19/12/2023
MHRA-100850-PIP01-23
  • deucravacitinib
  • Treatment of Sjogren's Syndrome
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100718-PIP01-22-M02 (update)
  • deucravacitinib
  • Treatment of psoriasis
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • SOTYKTU
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100855-PIP01-23-M01 (update)
  • DOPAMINE HYDROCHLORIDE
  • Treatment of vascular hypotensive disorders
  • Neoatricon
  • Cardiovascular Diseases
  • Neonatology - Paediatric Intensive Care
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 25/05/2023
MHRA-100865-PIP01-23-M01 (update)
  • RILPIVIRINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • REKAMBYS
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100669-PIP01-22-M02 (update)
  • RILPIVIRINE
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Odefsey
  • Odefsey
  • Odefsey
  • Infectious diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 30/01/2024
MHRA-100657-PIP01-22-M01 (update)
  • BULEVIRTIDE
  • Treatment of chronic hepatitis D infection
  • Hepcludex
  • Hepcludex
  • Myrcludex B
  • Gastroenterology-Hepatology
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
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-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 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-100351-PIP01-21-M01 (update)
  • DOLUTEGRAVIR
  • RILPIVIRINE
  • Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JASUPA
  • Juluca 50mg/25mg film-coated tablets
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-101053-PIP01-23-M01 (update)
  • DOLUTEGRAVIR
  • ABACAVIR
  • LAMIVUDINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • TRIUMEQ
  • TRIUMEQ
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 30/01/2024
MHRA-100351-PIP01-21-M02 (update)
  • DOLUTEGRAVIR
  • RILPIVIRINE
  • Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.
  • Juluca 50mg/25mg film-coated tablets
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JASUPA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
MHRA-100543-PIP01-22-M02 (update)
  • DOLUTEGRAVIR
  • LAMIVUDINE
  • Treatment of Human Immunodeficiency virus (HIV - 1) Infection
  • Dovato
  • Dovato
  • Dovato
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/04/2024
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-100630-PIP01-22-M01 (update)
  • PATIROMER SORBITEX CALCIUM
  • Treatment of hyperkalaemia
  • Veltassa
  • Other: Nephrology/Metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 25/05/2023
MHRA-100552-PIP01-22-M01 (update)
  • RILPIVIRINE HYDROCHLORIDE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • edurant
  • edurant
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 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