Polivy 140 mg and 30 mg powder for concentrate for solution for infusion
*Company:
Roche Registration GmbHStatus:
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 12 December 2024
File name
Polivy II-0032_31Oct2024_SmPC.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 December 2024
File name
Polivy II-0032_31Oct2024_PIL.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
Updated on 31 May 2022
File name
SmPC_Polivy_II-0012_24_May_2022.pdf
Reasons for updating
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/004870/II/0012. Inclusion of Polarix study Data (1L DLBCL).
Updated on 31 May 2022
File name
PIL_Polivy_II-0012_24_May_2022.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 13 May 2021
File name
SmPC_Polivy_IB-007_05-May-2021_clean.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.3 - Shelf life
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 13 May 2021
File name
PIL_Polivy_IB-007_05-May-2021_clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to date of revision
Updated on 16 December 2020
File name
SmPC_Polivy_R-03_09-Dec-2020_clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 16 December 2020
File name
PIL_Polivy_R-03_09-Dec-2020_clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 13 November 2020
File name
SmPC_Polivy II-02-G_15-Oct-2020_clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Introduction of new pack/pack size
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/004870/II/0002/G. Inclusion of 30mg formulation, updated transportation and in hold-use times, and compatibilities.
Updated on 13 November 2020
File name
PIL_Polivy II-02-G_15-Oct-2020_clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Introduction of new strength
Free text change information supplied by the pharmaceutical company
EMEA/H/C/004870/II/0002/G. Inclusion of 30mg formulation, updated transportation and in hold-use times, and compatibilities.
Updated on 21 January 2020
File name
SmPC_Polivy_V1.0_MAA_16-Jan-2020.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/004870/0000. Approval for a new MAA.
Updated on 21 January 2020
File name
PIL_Polivy_V1.0_MAA_16-Jan-2020.pdf
Reasons for updating
- New PIL for new product
Roche Registration GmbH
Address:
3004 Lake Drive, Citywest, Naas Road, Dublin 24Medical Information E-mail:
ireland.druginfo@roche.comTelephone:
+353 1 469 0700Fax:
+353 1 469 0791