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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-100711-PIP01-22-M01 (update)	TISAGENLECLEUCEL	Treatment of B cell acute lymphoblastic leukaemia/lymphoblastic lymphoma	Kymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusion Kymriah Kymriah 1.2 x 106 – 6 x 108 cells dispersion for infusion	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100361-PIP01-21-M02 (update)	GOLIMUMAB	Treatment of ulcerative colitis	Simponi	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100335-PIP01-21-M01 (update)	Erdafitinib	Treatment of all conditions included in the category of malignant neoplasms (except urothelial carcinoma, haematopoietic and lymphoid tissue neoplasm)	BALVARSA BALVERSA ERFANDEL tablet BALVERSA BALVERSA BALVERSA BALVERSA BALVERSA BALVERSA BALVERSA	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100114-PIP01-21-M01 (update)	BARICITINIB	Treatment of coronavirus disease 2019 (COVID-19)	Olumiant Olumiant	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100816-PIP01-22-M01 (update)	crovalimab	Treatment of paroxysmal nocturnal haemoglobinuria Treatment of atypical haemolytic uremic syndrome		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/05/2023
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-100550-PIP01-22-M01 (update)	BELIMUMAB	Treatment of systemic lupus erythematosus	Benlysta Benlysta Benlysta Benlysta Benlysta Benlysta	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100855-PIP01-23-M01 (update)	DOPAMINE HYDROCHLORIDE	Treatment of vascular hypotensive disorders	Neoatricon	Cardiovascular Diseases Neonatology - Paediatric Intensive Care	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	25/05/2023
MHRA-100657-PIP01-22-M01 (update)	BULEVIRTIDE	Treatment of chronic hepatitis D infection	Hepcludex Hepcludex Myrcludex B	Gastroenterology-Hepatology Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100627-PIP01-22-M01 (update)	Liposomal ciclosporin A (L-CsA)	Treatment of bronchiolitis obliterans syndrome (BOS)		Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100610-PIP01-22-M01 (update)	ECULIZUMAB	Treatment of myasthenia gravis	SOLIRIS SOLIRIS	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		25/05/2023
MHRA-100170-PIP01-21-M02 (update)	CANAGLIFLOZIN HEMIHYDRATE	Treatment of Type 2 Diabetes Mellitus	Invokana	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100128-PIP01-21-M02 (update)	tiomolibdic acid	Wilson disease		Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100632-PIP01-22-M01 (update)	FLUCICLOVINE (18F)	Diagnosis of amino acid metabolism in solid malignant tumours	Axumin Axumin Axumin Axumin Axumin Axumin Axumin Axumin	Diagnostic Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023
MHRA-100609-PIP01-22-M01 (update)	LENVATINIB MESILATE	Treatment of papillary thyroid cancer and follicular thyroid cancer Treatment of osteosarcoma	Lenvima Kisplyx Lenvima Kisplyx Lenvima Kisplyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100761-PIP01-22-M01 (update)	NIVOLUMAB relatlimab	Treatment of melanoma	Opdualag Opdualag Opdualag Opdualag	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100571-PIP01-22-M01 (update)	TENOFOVIR DISOPROXIL FUMARATE	Treatment of human immunodeficiency virus (HIV-1) infection Treatment of chronic viral hepatitis B	Viread Viread Viread Viread Viread	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100340-PIP01-21-M02 (update)	LANADELUMAB	Prevention of hereditary angioedema attacks	TAKHZYRO TAKZHYRO TAKZHRYO TAKHZYRO TAKHZYRO TAKHZYRO TAKZHYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO TAKHZYRO	Other: Genetic disease	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100078-PIP01-21-M03 (update)	AZTREONAM AVIBACTAM	Treatment of infections caused by aerobic gram-negative bacteria		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023
MHRA-100532-PIP01-22-M02 (update)	BUROSUMAB	Treatment of X-linked Hypophosphataemia	Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita Crysvita	Other: musculoskeletal disorder; osteology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		25/05/2023

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