Rebif Initiation Pack Solution for Injection in Cartridge *
Pharmacy Only: Prescription

  • Company:

    Merck
  • Status:

    Updated
  • 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 03 November 2022

File name

6363a6872eddd.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)

Free text change information supplied by the pharmaceutical company

NI update to AE reporting statement

Updated on 19 September 2022

File name

632841cee387a.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Free text change information supplied by the pharmaceutical company

Implementation of the Brexit changes 

Internal reference number: TW2704494 


Updated on 15 December 2020

File name

CARTRIDGE - 8822MCG PIL_1608033387.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Update of section 2, with regard to benzyl alcohol and sodium content.  

​Our reference: TW 2704494

Updated on 15 December 2020

File name

Rebif CARTRIDGES - UK and IE - Current - SPCv14 - TW2704494 - CLEAN_1608033267.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Changes include an update of section 2 and 4.4 of the SmPC, with regard to benzyl alcohol and sodium content. In addition, a numerical value in a table in section 5.1 was amended. 

​Our reference: TW 2704494
 

Updated on 07 September 2020

File name

Rebif_combined_cartridges_UK_and_IE_current_SPC_v13.0_TW2572377_1599480894.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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 07 September 2020

File name

Pil Init Cart - Deletion of Rebislide_1599480840.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 16 January 2020

File name

PIL - 8.8 and 22 MCG solution for injection in Cartridges_1579167542.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 15 January 2020

File name

Rebif_combined_cartridges_UK_and_IE_current_SPC_v12.0_TW2193790_1579096399.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 October 2019

File name

Rebif PIL initcart - Pregnancy - 09-19 - TW2098021_1571692486.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 17 October 2019

File name

Rebif_combined_cartridges_UK_and_IE_current_SPC_v11.0_TW2098021_1571318761.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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 25 July 2018

File name

Rebif initiation cartridges leaflet TW1735675.pdf

Reasons for updating

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

Updated on 25 July 2018

File name

Rebif_combined_cartridges_UK_and_IE_current_SPC_v10.0_TW1735675.pdf

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)

Updated on 13 May 2018

File name

Rebif_combined_cartridges_UK_and_IE_current_SPC_v9.0_TW1632207 (1).docx

Reasons for updating

  • New SPC for new product

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

Updated on 02 May 2018

File name

Rebif_combined_cartridges_UK_and_IE_current_SPC_v9.0_TW1632207 (1).docx

Reasons for updating

  • New SPC for new product

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

Updated on 27 April 2018

File name

Rebif_combined_cartridges_UK_and_IE_current_SPC_v9.0_TW1632207 (1).docx

Reasons for updating

  • New SPC for new product

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

Updated on 15 October 2015

File name

PIL_15315_99.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 October 2015

Reasons for updating

  • Change to side-effects

Updated on 24 July 2015

Reasons for updating

  • Change to side-effects

Updated on 05 January 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 30 July 2014

Reasons for updating

  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 17 April 2014

Reasons for updating

  • Change to side-effects
  • Change to dosage and administration
  • Change of distributor details

Updated on 22 August 2013

Reasons for updating

  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects

Updated on 05 October 2012

Reasons for updating

  • Change to side-effects

Updated on 04 April 2012

Reasons for updating

  • New PIL for medicines.ie