*** Disclaimer: This Database is still undergoing update on daily basis to prevent errors, discrepancies, and missing records. Please Contact FDIC@nafdac.gov.ng for enquires ***

Product Details

Pivikto 150mg Film Coated Tablet

Alpelisib
150 mg
Film coated tablet

ROA

Oral

Applicant Name

Novartis Nigeria Limited

NRN

A4-100514

Status

Active


ATC Code

L01EM0  

Product Category

Drugs

Marketing Category

Prescription-only Medicine (POM)  

Packsize

28 x 150mg, 56 x 150mg  

Product Description

Pivikto 150mg Film Coated Tablet Alpelisib Alpelisib 150mg; Microcrystalline cellulose (PH102) 79.8mg; D-Mannitol 69mg; Microcrystalline cellulose  (PH101) 34.2mg; Sodium starch glycolate (Type A) 15mg; Hypromellose 9mg; Magnesium stearate 6mg; Coating premix black 0.079mg - (Hypromellose 0.056mg; Iron oxide, black (E 172), Ferrosoferric oxide 0.011mg; Macrogol 4000, Polyethylene glycol (PEG) 4000 0.006mg; Talc 0.006mg); Coating premix red 0.476mg - (Hypromellose 0.340mg; Iron oxide, red (E 172), Red ferric oxide 0.068mg; Macrogol 4000, 28 x 150mg, 56 x 150mg Prescription Only Medicine (POM) 15/03/2023 NOVARTIS NIGERIA LIMITED, LANDMARK BUILDING 52/54 ISAAC JOHN STREET IKEJA-GRA LAGOS LAGOS Novartis Farma S.P.A, Novartis Farma S.P.A Torre Annunziata, Italy, Switzerland

Manufacturer Name

Novartis Farma S.p.A.

Manufacturer Country

ITALY  

Approval Date

2023-08-31  

Expiry Date

2028-08-30