Displaying 81 - 100 of 333
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100334-PIP01-21-M01 (update)
  • INDACATEROL ACETATE
  • GLYCOPYRRONIUM BROMIDE
  • MOMETASONE FUROATE
  • Treatment of asthma
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Enerzair Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Zimbus Breezhaler
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100343-PIP01-21-M01 (update)
  • MACITENTAN
  • Treatment of pulmonary arterial hypertension
  • systemic sclerosis
  • idiopathic pulmonary fibrosis
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Zependo
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Zependo
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100325-PIP01-21-M01 (update)
  • NALDEMEDINE
  • Treatment of opioid-induced constipation
  • Rizmoic
  • Rizmoic
  • SYMPROIC
  • SYMPROIC
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100300-PIP01-21-M01 (update)
  • DARUNAVIR
  • COBICISTAT
  • Treatment of HIV-1 Infection
  • REZOLSTA
  • REZOLSTA
  • REZOLSTA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100321-PIP01-21-M01 (update)
  • GUSELKUMAB
  • Chronic idiopathic arthritis (including rheumatoid, psoriatic, ankylosing spondylitis and JIA)
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100286-PIP01-21-M01 (update)
  • USTEKINUMAB
  • Treatment of ulcerative colitis
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100283-PIP01-21-M01 (update)
  • USTEKINUMAB
  • Treatment of Crohn's disease
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100284-PIP01-21-M01 (update)
  • MEXILETINE HYDROCHLORIDE
  • Treatment of myotonic disorders
  • Other: Muscle disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100198-PIP01-21-M01 (update)
  • RURIOCTOCOG ALFA PEGOL
  • Treatment and prophylaxis of bleeding in patients with haemophilia A
  • Adynovi
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 02/11/2022
MHRA-100347-PIP01-21
  • Respiratory Syncytial Virus Stabilised Prefusion F Subunit Vaccine (RSVpreF, PF-06928316)
  • Prevention of lower respiratory track disease caused by RSV via maternal immunisation.
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100239-PIP01-21
  • multivalent pneumococcal polysaccharide conjugate vaccine
  • Prevention of disease caused by Streptococcus pneumoniae
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100069-PIP01-21
  • RIBOCICLIB
  • Treatment of neuroblastoma
  • KISQALI
  • KISQALI
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100470-PIP01-22
  • Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein, Neisseria meningitidis serogroup B fHbp subfamily A, Neisseria meningitidis serogroup B fHbp subfamily B,
  • Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100372-PIP01-21
  • concizumab
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
  • Not available at present
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100355-PIP02-22
  • Fenebrutinib
  • Treatment of multiple sclerosis
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100234-PIP01-21
  • (S)-N-(1-amino-4-(dimethylamino)-1-oxobutan-2-yl)-5-(2,4-difluorophenoxy)-1-isobutyl-1H-indazole-6-carboxamide
  • Treatment of dilated cardiomyopathy due to lamin A/C gene mutations
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 02/11/2022
MHRA-100075-PIP01-21
  • leniolisib
  • Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)
  • Not available at present
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 02/11/2022
MHRA-100019-PIP01-21
  • 2-(3-(4-(1H-INDAZOL-5-YLAMINO)QUINAZOLIN-2-YL)PHENOXY)-N-ISOPROPYLACETAMIDE-METHANE SULFONIC ACID SALT
  • Treatment of chronic Graft versus Host Disease (cGVHD)
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/10/2022
MHRA-100177-PIP01-21-M01 (update)
  • INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN
  • INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN
  • INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN
  • INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN
  • Prevention of influenza
  • FLUCELVAX TETRA
  • FLUCELVAX TETRA
  • FLUCELVAX QUADRIVALENT
  • FLUCELVAX QUAD
  • FLUCELVAX QUAD
  • FLUCELVAX QUAD
  • FLUCELVAX QUAD
  • FLUCELVAX TETRA
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 21/10/2022
MHRA-100243-PIP01-21
  • DAPAGLIFLOZIN
  • 2-{(3S)-7-fluoro-4-[(3-oxo-3,4-dihydro-2H-1,4-benzoxazin-6-yl)carbonyl]-3,4-dihydro-2H-1,4-benzoxazin-3-yl}-N-methylacetamide (AZD9977)
  • Prevention of cardiovascular events in patients with chronic heart failure
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 21/10/2022