MVASI
*Company:
Amgen Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 03 January 2023
File name
en_mvasi_approved_pil_psur8_ie.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 03 January 2023
File name
en_mvasi_approved_spc_psur8_ie.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 September 2022
File name
en_mvasi_approved_pil_renewal_ie.pdf
Reasons for updating
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Updated on 30 September 2022
File name
en_mvasi_approved_spc_renewal_ie.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 July 2022
File name
en_mvasi_approved_pil_v28_ie.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 18 July 2022
File name
en_mvasi_approved_spc_v28_ie.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 July 2021
File name
en_mvasi_approved_spc_v23_ie.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- 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
Originator alignment:
4.4 Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
5.1 Pharmacodynamic properties
Paediatric population
Soft tissue sarcoma
In a randomised phase II study (BO20924) a total of 154 patients aged ≥ 6 months to < 18 years with newly diagnosed metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma were treated with standard of care (Induction IVADO/IVA+/- local therapy followed by maintenance vinorelbine and cyclophosphamide) with or without bevacizumab (2.5 mg/kg/week) for a total duration of treatment of approximately 18 months. At the time of the final primary analysis, the primary endpoint of EFS by independent central review did not show a statistically significant difference between the two treatment arms, with HR of 0.93 (95% CI: 0.61, 1.41; p-value = 0.72). The difference in ORR per independent central review was 18% (CI: 0.6%, 35.3%) between the two treatment arms in the few patients who had evaluable tumour at baseline and had a confirmed response prior to receiving any local therapy: 27/75 patients (36.0%, 95% CI: 25.2%, 47.9%) in the chemo arm and 34/63 patients (54.0%, 95% CI: 40.9%, 66.6%) in the BV + chemo arm. The secondary endpoint of overall survival was not mature. Until mature OS results and safety data are available no definitive conclusion can be drawn on the benefit/risk balance. The final overall survival (OS) analyses showed no significant clinical benefit from addition of bevacizumab to chemotherapy in this patient population.
6.6 Special precautions for disposal and other handling
MVASI should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution. A sterile needle and syringe should be used to prepare MVASI.
Updated on 14 July 2021
File name
en_mvasi_approved_pil_v23_ie.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to improve clarity and readability
Updated on 04 March 2021
File name
en_mvasi_approved_pil_v19_ie.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 04 March 2021
File name
en_mvasi_approved_spc_v19_ie.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 September 2020
File name
en_mvasi_approved_pil_v16.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 24 August 2020
File name
en_mvasi_approved_spc_v16.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 August 2020
File name
en_mvasi_approved_pil_v16.pdf
Reasons for updating
- New PIL for new product