Alymsys 25 mg/mL concentrate for solution for infusion
*Company:
Zentiva Pharma UK LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 16 November 2023
File name
For medicines ie 596154-01 PR BEVA ALYMSY 100_4,400_16 ZENTIVA IE 20.09.2023.pdf
Reasons for updating
- Change to section 1 - what the product is used for
Free text change information supplied by the pharmaceutical company
Paclitaxel added to the following paragraph:
When used for those adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back before 6 months after the last time they were treated with a chemotherapy regimen containing a platinum agent, Alymsys will be administered in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin.
Updated on 20 July 2023
File name
131-leaflet-clean.pdf
Reasons for updating
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Local rep number changed for Ireland
Updated on 20 July 2023
File name
For medicines ie Alymsys SmPC_EN_04-2023.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type II for the addition of a new indication
Alymsys, 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).
Updated on 04 May 2023
File name
For medicines ie Alymsys SmPC_EN_04-2023.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Shelf life changed to 36 months
Updated on 27 March 2023
File name
Pages from FOR medicines ie 589598-01 PR BEVA ALYMSY 1004,40016 ZENTIVA IE (4).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
Updated on 27 March 2023
File name
131-full-spc-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2
Do not shake the vial
including anaphylactic shock added to Hypersensitvity paragraph
Section 4.8
Anaphylactic shock added to rare adverse reaction table in the Immune system disorder
Section 6.6
Addition of "Shake the vial
Updated on 19 October 2021
File name
IE SmPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 October 2021
File name
NEW PIL 578915-01 V3 ZENTIVA IE.pdf
Reasons for updating
- New PIL for new product