en

PRODUCT DETAIL

Gefitinib Synthon 250 mg

Code 9892C
MA number 44/0410/18-S
Product Form: tbl flm 30x250 mg (blis.OPA/Al/PVC/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01X OTHER ANTINEOPLASTIC AGENTS
L01XE Protein kinase inhibitors
L01XE02 Gefitinib
Shelf life: 36
Container: blister OPA/Al/PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 10(1) generic application
MA issued: 19.12.2018
Validity: 19.12.2023
MA renewed: Renewal application submitted
PIL: PIL_Gefitinib Synthon 250 mg_tbl flm_12/2018_REG.docx  
SPC: SPC_Gefitinib Synthon 250 mg_tbl flm_12/2018_REG.docx  
Safety feature Yes
Data update: 04.01.2019
eu-flag.png sk-flag.png