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Rebif 22 mcg Solution for Injection in Pre-Filled Syringe

*
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):

    Interferon Beta-1a

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

Updated on 28 December 2022

File name

PIL_Rebif 22 mcg PFS - TW1735731 Dec2020.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Implement of the Brexit changes

Internal reference number: TW1735731

Updated on 03 November 2022

File name

Rebif SYRINGES - IENI - TW1735731 - Current v13.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 14 December 2020

File name

SYRINGE - 22MCG PIL.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 14 December 2020

File name

Rebif SYRINGES - UK and IE - Current - SPCv13 - TW2704494 - CLEAN.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 14 December 2020

File name

Rebif SYRINGES - UK and IE - Current - SPCv13 - TW2704494 - CLEAN.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 16 January 2020

File name

PIL - 22 MCG solution for injection in pre-filled syringe.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_pre_filled_syringes_UK_and_IE_current_SPC_v12.0_TW2193790.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 22mcgpfs12 - Pregnancy - 09-19 - TW2098021.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_pre_filled_syringes_UK_and_IE_current_SPC_v11.0_TW2098021.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 22 PFS 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_pre_filled_syringes_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_pre_filled_syringes_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 27 April 2018

File name

Rebif_combined_pre_filled_syringes_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 23 January 2018

File name

PIL_15310_392.pdf

Reasons for updating

  • New PIL for new product

Updated on 23 January 2018

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

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 19 July 2013

Reasons for updating

  • 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