OCREVUS 300 mg concentrate for solution for infusion *
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):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

Updated on 24 May 2021

File name

SmPC_Ocrevus_II-024_09-Apr-2021_Clean_1621863706.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 May 2021

File name

PIL_Ocrevus IB-025_20-Apr-2021_V2.0_Clean_1621595372.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 May 2021

File name

SmPC_Ocrevus IB-025_20-Apr-2021_V2.0_Clean_1621595151.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 28 April 2021

File name

SmPC_Ocrevus IB-025_20-Apr-2021_Clean_1619597427.pdf

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 27 April 2021

File name

SmPC_Ocrevus_II-023_04-Mar-2021_Clean_1619516762.pdf

Reasons for updating

  • 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)

Updated on 29 March 2021

File name

Irish SPC Ocrevus_V10.0_II-021_11-Feb-2021_CLEAN_1617021138.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)

Updated on 20 January 2021

File name

SmPC_Ocrevus_PSUSA 5_11Jan2021_Clean_1611144325.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 20 January 2021

File name

PIL_Ocrevus_PSUSA 5_11Jan2021_Clean_1611144227.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to date of revision

Updated on 12 January 2021

File name

SmPC_Ocrevus_II-020_26-Nov-2020_Clean_1610449209.pdf

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • 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 03 June 2020

File name

SmPC_Ocrevus_II-017_30-Apr-2020_clean_1591176922.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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/004043/II/0017

This variation is being submitted to support the addition of language in Annex I SmPC and Annex III B Package Leaflet, to allow for an alternative option of a shorter infusion for second and subsequent doses of Ocrevus® (2 hours, compared to the approved 3.5 hours infusion). The following sections have been updated: - SmPC Section 4.2, Posology and administration - SmPC Section 4.8, Undesirable effects - SmPC Section 5.1, Pharmacodynamic properties - Package Leaflet, Section 'How much and how often you will be given Ocrevus'. We have also taken this opportunity to correct some grammatical errors in the Package Leaflet i.e. removal of additional spaces or punctuation. These edits are shown in tracked changes in the annotated version.

Updated on 03 June 2020

File name

PIL_Ocrevus_II-017_30-Apr-2020_clean_1591176805.pdf

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Correction of spelling/typing errors

Updated on 24 April 2020

File name

SmPC_Ocrevus_IB-018_17-Apr-20_clean_1587722877.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

EMEA/H/C/004043/IB/0018. Type IB variation w/o linguistic review to extend DP shelf life from 18 to 24 months.

Updated on 24 April 2020

File name

PIL_Ocrevus_IB-018_17-Apr-20_clean_1587722824.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

EMEA/H/C/004043/IB/0018. Type IB variation w/o linguistic review to extend DP shelf life from 18 to 24 months.

Updated on 06 January 2020

File name

Ocrevus SmPC dated 16 Dec 2019_1578336303.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 28 June 2019

File name

uk-ie-mt-spc-Ocrevus-clean_1561714860.pdf

Reasons for updating

  • 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

OCREVUS, EMEA/H/C/PSUSA/00010662/201809, HA Request, CDS 4 (This change was requested by PRAC following review of PBRER No.2. The change has been made under a CDS deviation, therefore CDS 4.0 remains the current version.), Following review of the PBRER#2, the PRAC requested that an explicit link between a decrease in immunoglobulins and severe infection be introduced into SmPC section 4.8

Updated on 13 December 2018

File name

uk-ie-mt-pil-ocrevus-clean-181031-300mg-inf_1544713789.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 12 December 2018

File name

uk-ie-mt-spc-ocrevus-clean-181031-300mg-inf_1544610413.pdf

Reasons for updating

  • 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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Vaccination data from VELOCE study added to the SmPC. PIL updated accordingly

Section 9 updated

Updated on 11 December 2018

File name

uk-ie-mt-pil-ocrevus-clean-181031-300mg-inf_1544527120.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 11 December 2018

File name

uk-ie-mt-spc-ocrevus-clean-181031-300mg-inf_1544542751.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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 11 December 2018

File name

uk-ie-mt-spc-ocrevus-clean-181031-300mg-inf_1544542306.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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

Vaccination data from VELOCE study added to the SmPC. PIL updated accordingly

updated section 9

Updated on 11 December 2018

File name

uk-ie-mt-spc-ocrevus-clean-181031-300mg-inf_1544527068.pdf

Reasons for updating

  • 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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Vaccination data from VELOCE study added to the SmPC. PIL updated accordingly

Updated on 15 August 2018

File name

uk-ie-mt-pil-ocrevus-clean-180809-300mg-sol-inf_1534323031.pdf

Reasons for updating

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

Updated on 04 April 2018

Reasons for updating

  • New SPC for new product

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

Updated on 04 April 2018

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

7.       MARKETING AUTHORISATION HOLDER

 

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

United Kingdom

 



10.     DATE OF REVISION OF THE TEXT

 

23 March 2018

 

Updated on 28 March 2018

File name

PIL_17397_463.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 March 2018

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 17 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 17 January 2018

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

None provided

Updated on 15 January 2018

Reasons for updating

  • New PIL for new product