RoActemra 162 mg solution for injection in pre-filled pen
*Company:
Roche Registration GmbHStatus:
UpdatedLegal 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 05 April 2024
File name
PI2024-300426_RoAct SC PFP SmPC_IB.0122_Corr 04Apr2024.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
Republished RoActemra PFP SmPC dated 20 Mar 2024 (IB-0122G) on 05 Apr 2024 as some symbolswere incorrectly displaying in the originally published version.
Updated on 27 March 2024
File name
PI2024-299554_SmPC_3_IB-0122_RoActemra SC PFP_Mar24.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 25 January 2023
File name
RoActemra 162mg PFP SmPC dated 22Apr2022_CLEAN.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 October 2022
File name
RoActemra PFP PIL dated 15 Sep 2022.pdf
Reasons for updating
- Change to section 6 - date of revision
- Correction of spelling/typing errors
File name
RoActemra Dosing Guide IE Version 27.1.1.pdf
Reasons for updating
- Add New Doc
File name
RoActemra HCP Brochure IE Version 27.1.2.pdf
Reasons for updating
- Add New Doc
File name
RoActemra Patient Alert Card IE Version 27.1.0.pdf
Reasons for updating
- Add New Doc
File name
RoActemra Patient Brochure IE Version 27.1.0.pdf
Reasons for updating
- Add New Doc
Updated on 29 April 2022
File name
RoActemra 162mg PFP PIL dated Apr2022_CLEAN.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 29 April 2022
File name
RoActemra 162mg PFP SmPC dated 22Apr2022_CLEAN.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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 21 December 2021
File name
SmPC_RoActemra_PFP_II-0101_06-Dec-2021_V2_Clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 December 2021
File name
SPC RoActemra_PFP_II-0101_06-Dec-2021_Clean.pdf
Reasons for updating
- 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 14 December 2021
File name
PIL RoActemra_PFP_II-0101_06-Dec-2021_Clean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
EMEA/H/C/000955/II/0101. New Indication for COVID-19 (IV only). QRD 10.1 Annex IIIA alignment (removal of capitalisation for INN and removal of colons - all presentations).
Updated on 08 December 2021
File name
Irish SPC RoActemra_PFP_V12.0_II-0103G_11Nov2021_Clean.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
- 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 June 2021
File name
SmPC_RoActemra_PFP_25-May-2021_Clean.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
- 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 31 May 2021
File name
SmPC_RoActemra PFP_IB-0100_29-Mar-2021_Clean.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
RoActemra IE Version 25.4.1 HCP Brochure (1).pdf
Reasons for updating
- Add New Doc
File name
RoActemra IE Version 25.4.1 Patient Alert Card (2).pdf
Reasons for updating
- Add New Doc
File name
RoActemra IE Version 25.4.1 Dosing Guide (1).pdf
Reasons for updating
- Add New Doc
File name
RoActemra IE Version 25.4.1 Patient Brochure (2).pdf
Reasons for updating
- Add New Doc
Updated on 04 June 2020
File name
SmPC_RoActemra PFP_II-093G_30-Apr-2020_clean.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
- 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/000955/II/93G. G6 new drug substance manufacturing process for RoActemra IV and SC.
Updated on 09 April 2020
File name
SmPC_RoActemra PFP 162 mg_II-091_01-Apr-2020_clean.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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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/000955/II/0091. Addition of pJIA/sJIA to the Pre-Filled Pen (Autoinjector) label. Additional small editorial changes also included in this variation.
Updated on 09 April 2020
File name
PIL_RoActemra PFP 162 mg_II-091_01-Apr-2020_clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 3 - dose and frequency
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
EMEA/H/C/000955/II/0091. Addition of pJIA/sJIA to the Pre-Filled Pen (Autoinjector) label. Additional small editorial changes also included in this variation.
Updated on 20 November 2019
File name
SmPC_RoActemra_PFP_II-0086G_17-Oct-2019_CLEAN.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 November 2019
File name
PIL_RoActemra_PFP_II-0086G_17-Oct-2019.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 20 November 2019
File name
SmPC_RoActemra_PFS_II-0086G_17-Oct-2019_CLEAN.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
ACTEMRA, EMEA/H/C/000955/II/0086/G
To update existing text in Sections 4.2, 4.8, 5.1 and 5.2, minor additions to Annex II and updates to PL (Section 4). Update to Annexes to align with CDS 17.0 Update to RMP (25.2) Additional editorial updates to Annexes.
Updated on 20 November 2019
File name
PIL_RoActemra_PFS_II-0086G_17-Oct-2019.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 20 November 2019
File name
SmPC_RoActemra_PFP_II-0086G_17-Oct-2019_CLEAN.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 November 2019
File name
PIL_RoActemra_PFP_II-0086G_17-Oct-2019.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 02 September 2019
File name
SmPC RoActemra_PFP_V6.0_IB-088G_23-Aug-2019.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
ACTEMRA, EMEA/H/C/000955/IB/0088/G
CDS Update - Safety, 18.0
Update safety information to include PRAC-agreed wording on Hepatotoxicity.
Updated on 02 September 2019
File name
PIL RoActemra_PFP_V6.0_IB-088G_23-Aug-2019.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 23 January 2019
File name
uk-ie-mt-pil-RoActemra-clean-190115-162mg-pen.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 23 January 2019
File name
uk-ie-mt-spc-RoActemra-clean-190115-162mg-pen.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
Addition of new ADR hypofibrinogenaemia
Updated on 08 November 2018
File name
uk-ie-mt-pil-RoActemra-clean-181029-162mg.pen.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 07 November 2018
File name
uk-ie-mt-spc-RoActemra-clean-181029-162mg.pen.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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- 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
Minor changes (part of the II/76 variation)
Updated on 17 August 2018
File name
uk-ie-mt-pil-RoActemra-clean-180809-162mg-pen.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 06 June 2018
File name
uk-ie-mt-spc-RoActemra-clean-180412-162mg-pen.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
MAH change from Roche Registration Ltd (UK) to Roche Registration GmBH (Germany) + other minor amendments
Updated on 18 May 2018
File name
uk-ie-mt-pil-RoActemra-clean-180412-162mg-pen.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 29 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 March 2018
File name
PIL_17432_421.pdf
Reasons for updating
- New PIL for new product