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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100246-PIP01-21
  • MK-1026
  • Treatment of mature B-cell malignancies
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100176-PIP01-21
  • favezelimab
  • PEMBROLIZUMAB
  • Malignant neoplasms (except CNS, haematopoietic, lymphoid-tissue-& melanoma)
  • Neoplasms of CNS
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100187-PIP01-21-M02 (update)
  • VONICOG ALFA
  • Treatment of von Willebrand Disease
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Vonvendi
  • veyvondi
  • Haematology-Hemostaseology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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
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
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
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
MHRA-100035-PIP01-21
  • POVIDONE-IODINE
  • ISOPROPYL ALCOHOL
  • Prevention of infection prior to invasive procedures
  • PurPrep
  • Other: Antiseptic
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100431-PIP01-22
  • derivative of pyrrolopyrimidine
  • Prevention of cardiovascular events in patients with heart failure
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100185-PIP01-21
  • Anti-C1s Humanized IgG4 Monoclonal Antibody
  • Treatment of cold agglutinin disease
  • Neurology
  • Immunology -Rheumatology-Transplantation
  • Haematology-Hemostaseology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100125-PIP01-21
  • PEMBROLIZUMAB
  • vibostolimab
  • Malignant neoplasms (except CNS, haematopoietic, lymphoid tissue melanoma)
  • Malignant CNS neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100136-PIP01-21
  • PEMBROLIZUMAB
  • quavonlimab
  • All conditions of malignant neoplasms (except haematopoietic, lymphoid tissue and melanoma).
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100328-PIP01-21-M01 (update)
  • METRELEPTIN
  • Treatment of lipodystrophy
  • Myalepta Powder for Solution for Injection
  • Myalepta
  • Myalepta
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100233-PIP01-21-M01 (update)
  • CABOZANTINIB
  • Treatment of malignant solid tumours
  • Cabometyx
  • Cometriq
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Aptimetyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cabometyx
  • Cometriq
  • Cabometyx
  • Cometriq
  • Cabometyx
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100260-PIP01-21-M01 (update)
  • CEMIPLIMAB
  • Treatment of all malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Libtayo
  • Libtayo
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100487-PIP01-22
  • exebacase
  • Treatment of Staphylococcus aureus bacteraemia
  • Infectious diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100454-PIP01-22
  • adagrasib
  • Treatment of all solid and haematological malignancies
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100374-PIP01-21
  • Adeno-associated virus serotype 1 vector containing the human progranulin GRN gene
  • Treatment of frontotemporal dementia
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100295-PIP01-21
  • Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; (ABBV-154).
  • Treatment of polymyalgia rheumatica
  • Immunology -Rheumatology-Transplantation
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100226-PIP01-21
  • Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; ABBV-154
  • Treatment of chronic idiopathic arthritis (rheumatoid, psoriatic, JIA, ankylosing spondylitis)
  • Immunology -Rheumatology-Transplantation
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
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