RoActemra 162 mg solution for injection in pre-filled pen

*
Pharmacy Only: Prescription
  • Company:

    Roche Registration GmbH
  • Status:

    No Recent Update
  • Legal 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

EDM Updated on 22 July 2022

File name

RoActemra Dosing Guide IE Version 27.1.1.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 22 July 2022

File name

RoActemra HCP Brochure IE Version 27.1.2.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 22 July 2022

File name

RoActemra Patient Alert Card IE Version 27.1.0.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 22 July 2022

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)

EDM Updated on 25 November 2020

File name

RoActemra IE Version 25.4.1 HCP Brochure (1).pdf

Reasons for updating

  • Add New Doc

EDM Updated on 25 November 2020

File name

RoActemra IE Version 25.4.1 Patient Alert Card (2).pdf

Reasons for updating

  • Add New Doc

EDM Updated on 25 November 2020

File name

RoActemra IE Version 25.4.1 Dosing Guide (1).pdf

Reasons for updating

  • Add New Doc

EDM Updated on 25 November 2020

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