RoActemra 162 mg solution for injection in pre-filled pen

  • Name:

    RoActemra 162 mg solution for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    tocilizumab

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/06/20

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 4/6/2020

Click on this link to Download PDF directly

Roche Registration GmbH

Company Products

Medicine NameActive Ingredients
Medicine Name Alecensa 150 mg Hard Capsules Active Ingredients Alectinib hydrochloride
Medicine Name Avastin 25mg/ml concentrate for solution for infusion Active Ingredients Bevacizumab
Medicine Name CellCept 1g/5ml Powder for Oral Suspension Active Ingredients Mycophenolate Mofetil
Medicine Name CellCept 250mg Capsules Active Ingredients Mycophenolate Mofetil
Medicine Name CellCept 500mg Film-coated Tablets Active Ingredients Mycophenolate Mofetil
Medicine Name CellCept 500mg powder for concentrate for solution for infusion Active Ingredients Mycophenolate mofetil hydrochloride
Medicine Name Cotellic 20 mg film-coated tablets Active Ingredients Cobimetinib hemifumarate
Medicine Name Erivedge 150 mg Hard Capsules Active Ingredients Vismodegib
Medicine Name Esbriet 267 mg Hard Capsules Active Ingredients Pirfenidone
Medicine Name Esbriet 267 mg, 534 mg and 801 mg Film-coated Tablets Active Ingredients Pirfenidone
Medicine Name Gazyvaro 1,000 mg concentrate for solution for infusion Active Ingredients Obinutuzumab
Medicine Name Hemlibra 150 mg/mL Solution for Injection Active Ingredients Emicizumab
Medicine Name Hemlibra 30 mg/mL Solution for Injection Active Ingredients Emicizumab
Medicine Name Herceptin 150mg Powder for concentrate for solution for infusion Active Ingredients Trastuzumab
Medicine Name Herceptin 600 mg Solution for Injection in Vial Active Ingredients Trastuzumab
Medicine Name Kadcyla 100mg & 160mg powder for concentrate for solution for infusion Active Ingredients Trastuzumab emtansine
Medicine Name MabThera 100 mg and 500 mg concentrate for solution for infusion Active Ingredients Rituximab
Medicine Name MabThera 1400 mg Solution for Subcutaneous Injection Active Ingredients Rituximab
Medicine Name NeoRecormon solution for injection Pre-Filled Syringe Active Ingredients Epoetin beta
Medicine Name OCREVUS 300 mg concentrate for solution for infusion Active Ingredients Ocrelizumab
Medicine Name Pegasys 90, 135 and 180 micrograms solution for injection in pre-filled syringe Active Ingredients Peginterferon alfa-2a
Medicine Name Perjeta 420 mg Concentrate for Solution for Infusion Active Ingredients Pertuzumab
Medicine Name Polivy 140 mg and 30 mg powder for concentrate for solution for infusion Active Ingredients Polatuzumab Vedotin
Medicine Name RoActemra 162 mg solution for injection in pre-filled pen Active Ingredients tocilizumab
Medicine Name RoActemra 162 mg solution for injection in pre-filled syringe Active Ingredients tocilizumab
1 - 0 of 36 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 25 November 2020 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 25 November 2020 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 25 November 2020 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 25 November 2020 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 4 June 2020

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

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 4 June 2020 PIL

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to date of revision

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 9 April 2020

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

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 9 April 2020 PIL

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

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects

Updated on 20 November 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 20 November 2019

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects

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 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 20 November 2019

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects

Updated on 20 November 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 2 September 2019

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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 2 September 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 23 January 2019 PIL

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

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

Free text change information supplied by the pharmaceutical company

Addition of new ADR hypofibrinogenaemia

Updated on 8 November 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 7 November 2018

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

Free text change information supplied by the pharmaceutical company

Minor changes (part of the II/76 variation)

Updated on 17 August 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 6 June 2018

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 PIL

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 SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 March 2018 PIL

Reasons for updating

  • New PIL for new product
  • RoActemra® (tocilizumab) Important Safety Information for PatientsRisk Minimisation Materials

    files-icon(Click to Download)
  • RoActemra® (tocilizumab) (SC and IV) Patient Alert CardRisk Minimisation Materials

    files-icon(Click to Download)