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Displaying 1 - 20 of 295
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Sort ascending Decision Type Compliance Check Compliance outcome Date Published
MHRA-100689-PIP01-22
  • Dersimelagon
  • Treatment of systemic sclerosis
  • Other: Autoimmune and immune dysfunction diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/04/2024
MHRA-100114-PIP01-21
  • BARICITINIB
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Olumiant
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 03/11/2021
MHRA-100022-PIP01-21
  • bimekizumab
  • Hidradenitis suppurativa
  • Immunology -Rheumatology-Transplantation
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/11/2021
MHRA-100135-PIP01-21
  • anti-CD40L humanized monoclonal antibody (SAR441344)
  • Treatment of Sjogren's Syndrome
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 17/05/2022
MHRA-100265-PIP01-21
  • BARICITINIB
  • Treatment of alopecia areata
  • Olumiant
  • Olumiant
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100293-PIP01-21
  • lenzilumab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • 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 29/07/2022
MHRA-100304-PIP01-21
  • rozibafusp alfa
  • Treatment of systemic lupus erythematosus (SLE)
  • Not available at present
  • Immunology -Rheumatology-Transplantation
  • Other: Inflammation-Rheumatology SLE
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
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 27/09/2022
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 27/09/2022
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-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-100421-PIP01-22
  • efavaleukin alfa
  • Treatment of systemic lupus erythematosus (SLE)
  • 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 02/02/2023
MHRA-100587-PIP01-22
  • lusvertikimab
  • Treatment of Sjögren’s syndrome
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023
MHRA-100737-PIP01-22
  • Clazakizumab
  • Prevention and treatment of rejection of transplanted kidney
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/06/2023
MHRA-100513-PIP01-22
  • efgartigimod alfa
  • Treatment of dermatomyositis
  • Treatment of immune-mediated necrotizing myopathy
  • Treatment of polymyositis (including antisynthetase syndrome)
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
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-100927-PIP01-23
  • Namilumab
  • Treatment of sarcoidosis
  • Not available at present
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023
MHRA-100301-PIP03-23
  • Nipocalimab
  • Treatment of Sjögren’s syndrome
  • Immunology -Rheumatology-Transplantation
W: decision granting a waiver in all age groups for the listed condition(s). No 19/12/2023