ALVOCEVA FILM-COATED TABLETS 150MG

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

Erlotinib hydrochloride eqv Erlotinib

Commercializzato da:

LOTUS INTERNATIONAL PTE. LTD.

Codice ATC:

L01EB02

Forma farmaceutica:

TABLET, FILM COATED

Composizione:

Erlotinib hydrochloride eqv Erlotinib 150.00mg

Via di somministrazione:

ORAL

Tipo di ricetta:

Prescription Only

Prodotto da:

Remedica Ltd

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2020-11-19

Foglio illustrativo

1
1.
NAME OF THE MEDICINAL PRODUCT
ALVOCEVA 25 mg tablets
ALVOCEVA 50 mg tablets
ALVOCEVA 100 mg tablets
ALVOCEVA 150 mg tablets
Not all presentations are available.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg erlotinib (as erlotinib
hydrochloride).
Each film-coated tablet contains 50 mg erlotinib (as erlotinib
hydrochloride).
Each film-coated tablet contains 100 mg erlotinib (as erlotinib
hydrochloride).
Each film-coated tablet contains 150 mg erlotinib (as erlotinib
hydrochloride).
Excipient with known effect:
Each 25 mg film-coated tablet contains 23.98 mg lactose monohydrate.
Each 50 mg film-coated tablet contains 47.97 mg lactose monohydrate.
Each 100 mg film-coated tablet contains 95.93 mg lactose monohydrate.
Each 150 mg 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 (tablet).
White to yellowish, round biconvex, film-coated tablet, engraved with
“25” on one side. The diameter
of the tablet is 6.1 mm±5%.
White to yellowish, round biconvex, film-coated tablet, engraved with
“50” on one side. The diameter
of the tablet is 7.6 mm±5%.
White to yellowish, round biconvex, film-coated tablet, engraved with
“100” on one side. The
diameter of the tablet is 8.9 mm±5%.
White to yellowish, round biconvex, film-coated tablet, engraved with
“150” on one side. The
diameter of the tablet is 10.5 mm±5%.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-Small Cell Lung Cancer (NSCLC):
Erlotinib 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 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 is also indicated for the treatment of patients with locally
advanced or metastatic non-small
cell lung cance

Scheda tecnica

1
1.
NAME OF THE MEDICINAL PRODUCT
ALVOCEVA 25 mg tablets
ALVOCEVA 50 mg tablets
ALVOCEVA 100 mg tablets
ALVOCEVA 150 mg tablets
Not all presentations are available.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg erlotinib (as erlotinib
hydrochloride).
Each film-coated tablet contains 50 mg erlotinib (as erlotinib
hydrochloride).
Each film-coated tablet contains 100 mg erlotinib (as erlotinib
hydrochloride).
Each film-coated tablet contains 150 mg erlotinib (as erlotinib
hydrochloride).
Excipient with known effect:
Each 25 mg film-coated tablet contains 23.98 mg lactose monohydrate.
Each 50 mg film-coated tablet contains 47.97 mg lactose monohydrate.
Each 100 mg film-coated tablet contains 95.93 mg lactose monohydrate.
Each 150 mg 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 (tablet).
White to yellowish, round biconvex, film-coated tablet, engraved with
“25” on one side. The diameter
of the tablet is 6.1 mm±5%.
White to yellowish, round biconvex, film-coated tablet, engraved with
“50” on one side. The diameter
of the tablet is 7.6 mm±5%.
White to yellowish, round biconvex, film-coated tablet, engraved with
“100” on one side. The
diameter of the tablet is 8.9 mm±5%.
White to yellowish, round biconvex, film-coated tablet, engraved with
“150” on one side. The
diameter of the tablet is 10.5 mm±5%.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-Small Cell Lung Cancer (NSCLC):
Erlotinib 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 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 is also indicated for the treatment of patients with locally
advanced or metastatic non-small
cell lung cance