|
Product class:
|
Authorized package
|
|
Medicinal product class:
|
For human use
|
|
Package code:
|
1846885
|
|
Name of medicinal product:
|
ABEVMY
|
|
Active substances:
|
|
|
ATC code:
|
L01FG01
|
|
Dosage form:
|
concentrate for solution for infusion
|
|
Route of administration:
|
intravenous use
|
|
Strengh:
|
25mg 1ml
|
|
Amount in package:
|
16ml 3TK
|
|
Legal status for supply*:
|
Subject to medicinal prescription
|
|
Class of active substance:
|
|
|
Additional information:
|
|
|
Indication:
|
Abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult
patients with metastatic carcinoma of the colon or rectum.
Abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with
metastatic breast cancer. For further information as to human epidermal growth factor receptor 2
(HER2) status, please refer to section 5.1.
Abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with
metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or
anthracyclines is not considered appropriate. Patients who have received taxane and
anthracycline-containing regimens in the adjuvant setting within the last 12 months should be
excluded from treatment with Abevmy in combination with capecitabine. For further information as to
HER2 status, please refer to section 5.1.
Abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult
patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than
predominantly squamous cell histology.
Abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with
unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with
Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1).
Abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients
with advanced and/or metastatic renal cell cancer.
Abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of
adult patients with advanced (International Federation of Gynecology and Obstetrics [FIGO] stages III
B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1).
Abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and
paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive
epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy
with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents.
Abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated
for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube,
or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who
have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–
targeted agents (see section 5.1).
Abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in
patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with
persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).
|
|
Safety features:
|
Yes
|
|
Summary of product characteristics (SPC):
|
|
|
Package information leaflet (PIL):
|
EST
|
|
Labelling:
|
|
|
Last imported to Estonia:
|
Never imported to Estonia
|
 :
|
This medicinal product is subject to additional monitoring. This will allow quick identification of
new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
|
|
Marketing authorization holder:
|
Biosimilar Collaborations Ireland Limited
|
|
Marketing authorization number:
|
EU/1/20/1515
|
|
Marketing authorization issued on:
|
21 April 2021
|
|
Marketing authorization expires on:
|
22 April 2026
|
|
Marketing authorization procedure type:
|
Centralised
|
|
Reference price:
|
|
|
Under reference price:
|
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
21 September 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription