Search Filters:

The items contained in the list are being used to filter the search results. Click them to remove them from the search filter.
Displaying 141 - 160 of 478
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100465-PIP01-22-M02 (update)
  • efanesoctocog alfa
  • Treatment of congenital haemophilia A
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 19/12/2023
MHRA-100137-PIP01-21-M02 (update)
  • linaclotide
  • Treatment of functional constipation
  • Constella
  • Constella
  • Constella
  • Constella
  • Constella
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100779-PIP01-22-M01 (update)
  • GUSELKUMAB
  • Treatment of chronic idiopathic arthritis (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100289-PIP01-21-M03 (update)
  • GALCANEZUMAB
  • Prevention of migraine headache
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Emgality
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100823-PIP01-22-M01 (update)
  • Recombinant Human A Disintegrin and Metalloprotease with Thrombospondin Type-1 Motifs 13 (rADAMTS13)
  • Treatment of thrombotic thrombocytopenic purpura
  • rADAMTS13
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 25/08/2023
MHRA-100102-PIP01-21-M02 (update)
  • INDACATEROL ACETATE
  • MOMETASONE FUROATE
  • Treatment of asthma
  • Atectura Breezhaler
  • Atectura Breezhaler
  • Atectura Breezhaler
  • Atectura Breezhaler and its duplicate authorization Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler
  • Atectura Breezhaler
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/08/2023
MHRA-100095-PIP01-21-M03 (update)
  • DORAVIRINE
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection
  • Pifeltro
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100094-PIP01-21-M02 (update)
  • DORAVIRINE
  • LAMIVUDINE
  • TENOFOVIR DISOPROXIL FUMARATE
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection
  • Delstrigo
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100786-PIP01-22-M01 (update)
  • TOFACITINIB CITRATE
  • Treatment of ulcerative colitis
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • XELJANZ
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100212-PIP01-21-M02 (update)
  • FINERENONE
  • Treatment of Chronic Kidney Disease
  • Kerendia
  • Kerendia
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100720-PIP01-22-M02 (update)
  • Gepotidacin
  • Treatment of uncomplicated urinary tract infection
  • Not available at present
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 24/08/2023
MHRA-100776-PIP01-22-M01 (update)
  • Nemolizumab
  • Treatment of atopic dermatitis.
  • Not yet defined
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100676-PIP01-22-M01 (update)
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • Treatment of human immunodeficiency virus (HIV-1) infection.
  • Descovy
  • Descovy
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100677-PIP01-22-M01 (update)
  • COBICISTAT
  • Treatment of human immunodeficiency virus type-1 (HIV-1) infection
  • Tybost
  • Tybost
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100778-PIP01-22-M01 (update)
  • GUSELKUMAB
  • Treatment of ulcerative colitis
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100690-PIP01-22-M01 (update)
  • IMIPENEM MONOHYDRATE
  • CILASTATIN SODIUM
  • RELEBACTAM MONOHYDRATE
  • Treatment of infections caused by gram-negative organisms.
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100332-PIP01-21-M01 (update)
  • sotatercept
  • Treatment of pulmonary arterial hypertension
  • Not available at present
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 24/08/2023
MHRA-100330-PIP01-21 -M01 (update)
  • 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)
  • Treatment of Mucopolysaccharidosis type I, Hurler syndrome (MPS-IH)
  • Not available at present
  • Other: Metabolic disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100268-PIP01-21-M03 (update)
  • INOTUZUMAB OZOGAMICIN
  • Treatment of B cell acute lymphoblastic leukaemia
  • Besponsa
  • Besponsa
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100268-PIP01-21-M02 (update)
  • INOTUZUMAB OZOGAMICIN
  • Treatment of B cell acute lymphoblastic leukaemia
  • Besponsa
  • Besponsa
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023