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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort ascending
MHRA-101210-PIP01-23	Zapomeran	Prevention of coronavirus disease 2019 (COVID-19)	Not available at present Kostaive	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/06/2024
MHRA-101269-PIP01-23	Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen	Prevention of zoonotic influenza	Celldemic Audenz	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Full Compliance Check Granted	24/06/2024
MHRA-101112-PIP01-23	Interleukin-23 receptor antagonist peptide (JNJ-77242113)	Treatment of psoriasis		Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/06/2024
MHRA-100918-PIP01-23	BELIMUMAB	Treatment of systemic sclerosis	Benlysta Benlysta Benlysta Benlysta	Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/06/2024
MHRA-101069-PIP01-23	resminostat mesilate	Treatment of cutaneous T-cell lymphoma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		24/06/2024
MHRA-101394-PIP01-24	clascoterone	Treatment of acne vulgaris	Winlevi 10 mg/g cream	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Full Compliance Check Granted	24/06/2024
MHRA-101172-PIP01-23	Disitamab vedotin	Treatment of solid tumours including central nervous system malignancies	Aidixi Aidixi	Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/06/2024
MHRA-101392-PIP01-24	Influenza Virus Type A, H1N1 Influenza Virus Type A, H3N2 Influenza Virus Type B, Victoria lineage	Prevention of influenza infection	Fluenz	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	Yes	Full Compliance Check Granted	24/06/2024
MHRA-101103-PIP01-23	FINERENONE	Treatment of heart failure	Kerendia Kerendia	Cardiovascular Diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/06/2024
MHRA-101169-PIP01-23	vibostolimab PEMBROLIZUMAB	Treatment of melanoma		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/06/2024
MHRA-101235-PIP01-23	Humanised monoclonal antibody derivative against fibroblast growth factor receptor 3	Treatment of achondroplasia		Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/06/2024
MHRA-101215-PIP01-23	Rocatinlimab	Treatment of prurigo nodularis		Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No		24/06/2024
MHRA-101171-PIP01-23	ABBV-CLS-7262 Sodium ({(2S)-1,4-bis[2-(4-chloro-3-fluorophenoxy)acetamido]bicyclo[2.2.2]octan-2-yl}oxy)methyl hydrogen phosphate-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1/1)	Treatment of vanishing white matter disease		Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		24/06/2024
MHRA-101298-PIP01-23	Ulviprubart	Treatment of inclusion body myositis	Not available at present	Immunology -Rheumatology-Transplantation Other: Musculoskeletal disorders	W: decision granting a waiver in all age groups for the listed condition(s).	No		24/06/2024
MHRA-101277-PIP01-23	LIVE ATTENUATED MEASLES VIRUS (SCHWARZ STRAIN) LIVE ATTEN'D MUMPS VIRUS (RIT 4385 DERIVED FROM JERYL LYNN) LIVE ATTENUATED RUBELLA (WISTAR RA 27/3 STRAIN) Varicella virus Oka strain (live, attenuated)	Prevention of measles, mumps, rubella and varicella		Vaccines	W: decision granting a waiver in all age groups for the listed condition(s).	No		24/06/2024
MHRA-101156-PIP01-23	Cagrilintide SEMAGLUTIDE	Type 2 Diabetes mellitus	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	W: decision granting a waiver in all age groups for the listed condition(s).	No		24/06/2024
MHRA-101265-PIP01-23	efgartigimod alfa	Treatment of thyroid eye disease	Vyvgar Vyvgart Vyvgart	Endocrinology-Gynaecology-Fertility-metabolism	W: decision granting a waiver in all age groups for the listed condition(s).	No		24/06/2024
MHRA-101226-PIP01-23	Volrustomig	Treatment of cervical cancer Treatment of renal cell carcinoma Treatment of lung cancer Treatment of mesothelioma	Volrustomig	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		24/06/2024
MHRA-101222-PIP01-23	SJP-0132	Treatment of Dry Eye Disease		Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No		24/06/2024
MHRA-101093-PIP02-23	satralizumab	Treatment for thyroid eye disease (TED)	Enspryng Enspryng Enspryng	Neurology Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No		24/06/2024

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