Erlotinib Pharmascience 100 mg film coated tablets

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

ERLOTINIB HYDROCHLORIDE

可用日期:

Pharmascience International Ltd Lampousas 1, 1095 Nicosia , Cyprus

ATC代码:

L01XE03

INN（国际名称）:

ERLOTINIB HYDROCHLORIDE 100 mg

药物剂型:

FILM-COATED TABLET

组成:

ERLOTINIB HYDROCHLORIDE 100 mg

处方类型:

POM

治疗领域:

ANTINEOPLASTIC AGENTS

產品總結:

Licence number in the source country: NOT APPLICAPABLE

授权状态:

Withdrawn

授权日期:

2021-01-05

资料单张

PAGE 1 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ERLOTINIB PHARMASCIENCE 100 MG FILM-COATED TABLETS
ERLOTINIB PHARMASCIENCE 150 MG FILM-COATED TABLETS
erlotinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Erlotinib Pharmascience is and what it is used for
2.
What you need to know before you take Erlotinib Pharmascience
3.
How to take Erlotinib Pharmascience
4.
Possible side effects
5
How to store Erlotinib Pharmascience
6.
Contents of the pack and other information
1.
WHAT ERLOTINIB PHARMASCIENCE IS AND WHAT IT IS USED FOR
Erlotinib Pharmascience contains the active substance erlotinib.
Erlotinib Pharmascience is a medicine
used to treat cancer by preventing the activity of a protein called
epidermal growth factor receptor
(EGFR). This protein is known to be involved in the growth and spread
of cancer cells.
Erlotinib Pharmascience is indicated for adults. This medicine can be
prescribed to you if you have
non-small cell lung cancer at an advanced stage. It can be prescribed
as initial therapy or as therapy if
your disease remains largely unchanged after initial chemotherapy,
provided your cancer cells have
specific EGFR mutations. It can also be prescribed if previous
chemotherapy has not helped to stop
your disease.
This medicine can also be prescribed to you in combination with
another treatment called gemcitabine
if you have cancer of the pancreas at a metastatic stage.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERLOTINIB PHARMASCIENCE
DO NOT TAKE
ERLOTINIB PHARMASCIENCE
•
if you are

产品特点

Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Erlotinib Pharmascience 100 mg film-coated tablets
Erlotinib Pharmascience 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Erlotinib Pharmascience 100 mg film-coated tablets_
Each film-coated tablet contains 100 mg erlotinib (as erlotinib
hydrochloride).
_Erlotinib Pharmascience 150 mg film-coated tablets_
Each film-coated tablet contains 150 mg erlotinib (as erlotinib
hydrochloride).
Excipient(s) with known effect:
_Erlotinib Pharmascience 100 mg film-coated tablets _
Each film-coated tablet contains 95.93 mg Lactose monohydrate.
_Erlotinib Pharmascience 150 mg film-coated tablets _
Each film-coated tablet contains 143.90 mg Lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_Erlotinib Pharmascience 100 mg film-coated tablets _
White to yellowish, round biconvex, film-coated tablet, engraved with
“100” on one side. The
diameter of the tablet is 8.9 mm.
_Erlotinib Pharmascience 150 mg film-coated tablets _
White to yellowish, round biconvex, film-coated tablet, engraved with
“150” on one side. The
diameter of the tablet is 10.5 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-Small Cell Lung Cancer (NSCLC):
Erlotinib Pharmascience is indicated for the first-line treatment of
patients with locally advanced or
metastatic non- small cell lung cancer (NSCLC) with EGFR activating
mutations.
Erlotinib Pharmascience is also indicated for switch maintenance
treatment in patients with locally
advanced or metastatic NSCLC with EGFR activating mutations and stable
disease after first-line
chemotherapy.
Erlotinib Pharmascience is also indicated for the treatment of
patients with locally advanced or
metastatic NSCLC after failure of at least one prior chemotherapy
regimen. In patients with tumours
without EGFR activating mutations, Erlotinib Pharmascience is
indicated when other treatment
options are not considered suitable.
When prescribing