Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1187849
|
Name of medicinal product:
|
ALIMTA
|
Active substances:
|
|
ATC code:
|
L01BA04
|
Dosage form:
|
powder for concentrate for solution for infusion
|
Route of administration:
|
intravenous use
|
Strengh:
|
500mg
|
Amount in package:
|
1TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
viaal
|
Indication:
|
Malignant pleural mesothelioma
ALIMTA in combination with cisplatin is indicated for the treatment of chemotherapy naive patients
with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
ALIMTA in combination with cisplatin is indicated for the first line treatment of patients with locally
advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology
(see section 5.1).
ALIMTA is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic
non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease
has not progressed immediately following platinum-based chemotherapy (see section 5.1).
ALIMTA is indicated as monotherapy for the second line treatment of patients with locally advanced
or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section
5.1)
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
August 30, 2017
|
Marketing authorization holder:
|
Eli Lilly Nederland B.V.
|
Marketing authorization number:
|
EU/1/04/290
|
Marketing authorization issued on:
|
September 20, 2004
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
February 20, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere