Product Details

Pivikto 200mg + 50mg Film Coated Tablets#

Alpelisib
200mg + 50mg
Tablet

ROA

Oral

Applicant Name

Novartis Nigeria Limited

NRN

A4-100496

Status

Active


Composition

 

ATC Code

L01EM0  

Product Category

Drugs

Marketing Category

Prescription-only Medicine (POM)  

Packsize

14 x 200mg + 14 x 50mg, 28 x 200mg + 28 x 50mg  

Product Description

Pivikto 200mg + 50mg Film Coated Tablets Alpelisib Light pink, unscored, round and curved with beveled edges, imprinted with “L7” on one side and “NVR” on the other side; Alpelisib 50mg; Microcrystalline cellulose (PH102) 26.60mg; D-Mannitol 23mg; Microcrystalline cellulose  (PH101) 11.4mg; Sodium starch glycolate (Type A) 5mg; Hypromellose 3mg; Magnesium stearate 2mg; Coating premix black 0.018mg - (Hypromellose 0.013mg; Iron oxide, black (E 172), Ferrosoferric oxide 0.003mg; Macrogol 4000, Polyethylene glycol (PEG) 4000 0.001mg; Talc 0.001 14 x 200mg + 14 x 50mg, 28 x 200mg + 28 x 50mg Prescription Only Medicine (POM) 15/03/2023 NOVARTIS NIGERIA LIMITED, LANDMARK BUILDING 52/54 ISAAC JOHN STREET IKEJA-GRA LAGOS LAGOS Novartis Pharma Stein AG, Novartis Pharma Stein AG Schaffhauserstrasse 4332 Stein AG, Switzerland, Switzerland

Manufacturer Name

Novartis Pharma Stein AG

Manufacturer Country

SWITZERLAND  

Approval Date

2023-08-31  

Expiry Date

2028-08-30