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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Date Published
MHRA-100733-PIP01-22	Botulinum toxin type E	Treatment of skin wrinkling		Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/06/2023
MHRA-100301-PIP02-22	Nipocalimab	Treatment of Bullous Pemphigoid		Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No	24/08/2023
MHRA-100917-PIP01-23	efgartigimod alfa	Treatment of Bullous Pemphigoid	Vyvgart Vyvgart Vyvgart Vyvgart	Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100276-PIP01-21-M03 (update)	BRODALUMAB	Treatment of psoriasis	Kyntheum Kyntheum Lumicef Siliq Kyntheum Kyntheum Kyntheum	Dermatology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/01/2024
MHRA-100395-PIP01-21	TALAZOPARIB TOSYLATE	Treatment of breast malignant neoplasms Treatment of prostate malignant neoplasms	Talzenna Talzenna Talzenna Talzenna Talzenna Talzenna	Psychiatry Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100107-PIP01-21	1-(3-methylbutanoyl)-l-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-(l-cystinyl-l-isoleucyl-[(n6-(s)-4-carboxy-4-palmitamidobutanoyl)-l-lysinyl]-l-phenylalanyl-l-glutamyl-l-prolyl-l-arginyl-l-serinyl-l-lysinyl-l-glycinyl-l-cystinyl)-l-lysinamide, disulfide, acetate	Treatment of polycythaemia vera		Haematology-Hemostaseology	W: decision granting a waiver in all age groups for the listed condition(s).	No	18/03/2022
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-101355-PIP01-24	(3S,10S,14S)-1-[4-[[(2S)-4-carboxy-2-[(2S)-4-carboxy-2-(6-[18F] fluoropyridin-3-amido)butanamido]butanamido]methyl]phenyl]-3-[(naphthalen-2-yl)methyl]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane-10,14,16-tricarboxylic acid ([18F]PSMA-1007)	Visualisation of prostate specific membrane antigen in prostate cancer	Radelumin	Diagnostic Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-100873-PIP01-23	Meningococcal Group A, C, W-135 and Y conjugate vaccine	Meningococcal meningitis	Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo Menveo	Vaccines	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100978-PIP01-23	Genetically detoxified Pertussis Toxin (PTgen) and Pertussis Filamentous Haemagglutinin (FHA)	Prevention of Pertussis disease	Pertagen Pertagen Pertagen Pertagen aPgen	Vaccines	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/01/2024
MHRA-100974-PIP01-23	BOTULINUM TOXIN TYPE A	Treatment of skin wrinkling	Not yet defined	Other: Aesthetics	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100279-PIP01-21	Humanized monoclonal antibody of IgG1 sub-type targeting the human SEMA3A polypeptide	Diabetic retinopathy		Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No	04/05/2022
MHRA-100493-PIP01-22	BI 765128 - humanized monoclonal antibody of IgG1 subtype targeting NRP1	Diabetic retinopathy		Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/05/2023
MHRA-101230-PIP01-23	teprotumumab	Treatment of thyroid eye disease	Not available at present TEPEZZA	Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No	30/04/2024
MHRA-100184-PIP01-21	BENRALIZUMAB	Non-cystic fibrosis bronchiectasis with an eosinophilic phenotype	FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA	Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/05/2022
MHRA-100194-PIP01-21	sivopixant	Treatment of unexplained or refractory chronic cough		Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/05/2022
MHRA-100186-PIP01-21	depemokimab	Treatment of chronic rhinosinusitus with nasal polyps (CRSwNP)	Depemokimab	Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	25/05/2023
MHRA-100933-PIP01-23	camlipixant	Treatment of unexplained or chronic refractory cough		Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-101019-PIP01-23	Treprostinil Palmitil	Treatment of pulmonary hypertension due to lung disease and/or hypoxia.	Not available at present	Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023
MHRA-100995-PIP01-23	LysoPhosphatidic Acid receptor 1 (LPA1) antagonist (BMS-986278)	Treatment of fibrosing Interstitial Lung Diseases (ILD)		Pneumology - Allergology	W: decision granting a waiver in all age groups for the listed condition(s).	No	19/12/2023

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