Rebif 44 mcg Solution for Injection in Cartridge *
Pharmacy Only: Prescription

  • Company:

    Merck
  • 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 15 December 2020

File name

CARTRIDGE - 44MCG PIL_1608033056.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_1608032982.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

Pil 44mcg Cart - Deletion of Rebislide_1599480778.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 07 September 2020

File name

Rebif_combined_cartridges_UK_and_IE_current_SPC_v13.0_TW2572377_1599480735.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.5 - Nature and contents of container
  • 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 16 January 2020

File name

PIL - 44 MCG solution for injection in Cartridges_1579167415.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_1579095078.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 44cart - Pregnancy - 09-19 - TW2098021_1571692348.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_1571318322.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 23 July 2018

File name

Rebif 44 cartridges leaflet TW1735675.pdf

Reasons for updating

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

Updated on 23 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 27 April 2018

File name

Rebif_combined_cartridges_UK_and_IE_current_SPC_v9.0_TW1632207.docx

Reasons for updating

  • New SPC for new product

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

Updated on 16 September 2015

File name

PIL_15312_305.pdf

Reasons for updating

  • New PIL for new product

Updated on 16 September 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 warnings or special precautions for use
  • 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