RoActemra 162 mg solution for injection in pre-filled pen
- Name:
RoActemra 162 mg solution for injection in pre-filled pen
- Company:
Roche Registration GmbH
- Active Ingredients:
- 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
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Roche Registration GmbH
Company Products
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 4 June 2020 SmPC
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 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 SmPC
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 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 SmPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 20 November 2019 SmPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 20 November 2019 SmPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 2 September 2019 SmPC
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 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 SmPC
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 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 SmPC
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 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 6 June 2018 SmPC
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 SmPC
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