Displaying 61 - 80 of 692
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort descending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100618-PIP01-22-M01 (update)
  • AVIBACTAM
  • CEFTAZIDIME
  • Treatment of intra-abdominal infections
  • Treatment of urinary tract infections
  • Treatment of pneumonia
  • Treatment of infections due aerobic Gram-negative organisms.
  • Zavicefta
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100845-PIP01-23-M01 (update)
  • CABOTEGRAVIR
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • VOCABRIA and CABENUVA
  • Apretude
  • APRETUDE
  • Apretude
  • VOCABRIA/APRETUDE
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 20/06/2023
MHRA-100845-PIP01-23-M02 (update)
  • CABOTEGRAVIR
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • N/A
  • VOCABRIA AND APRETUDE
  • Apretude
  • N/A
  • N/A
  • N/A
  • Apretude
  • Apretude
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 20/06/2023
MHRA-100195-PIP01-21-M02 (update)
  • BALOXAVIR MARBOXIL
  • Treatment of Influenza
  • Prevention of Influenza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100392-PIP01-21-M03 (update)
  • TOZINAMERAN
  • TOZINAMERAN/ FAMTOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty concentrate for dispersion for injection; COVID-19 mRNA Vaccine (nucleoside modified)
  • 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 30/06/2023
MHRA-100799-PIP01-22-M01 (update)
  • BEDAQUILINE FUMARATE
  • Treatment of multi-drug resistant tuberculosis
  • Sirturo
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100349-PIP01-21-M02 (update)
  • Rezafungin acetate
  • Treatment of invasive candidiasis
  • Rezzayo 200 mg powder for concentrate for solution for infusion
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100714-PIP01-22-M01 (update)
  • Gepotidacin
  • Treatment of uncomplicated urogenital gonorrhoea (GC)
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100720-PIP01-22-M01 (update)
  • Gepotidacin
  • Treatment of uncomplicated urinary tract infections
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
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-100029-PIP01-21-M01 (update)
  • RECOMBINANT REPLICATION-INCOMPETENT ADENOVIRUS SEROTYPE 26 VECTOR ENCODING THE SARS-COV-2 SPIKE PROTEIN PER.C6 CELL LINE
  • COVID-19 vaccine (Ad26.COV2-S [recombinant])
  • Prevention of coronavirus disease-2019 (COVID-19)
  • COVID-19 vaccine Janssen
  • Jcovden (previously COVID-19 Vaccine Janssen)
  • Infectious diseases
  • Vaccines
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100164-PIP01-21-M02 (update)
  • Nirmatrelvir
  • RITONAVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100612-PIP01-22
  • Fosmanogepix
  • Treatment of invasive fungal infections
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100670-PIP01-22
  • Ibrexafungerp citrate
  • Treatment of invasive candidiasis
  • Brexafemme
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) 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-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-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-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-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-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