Rebif 22 mcg Solution for Injection in Cartridge * Pharmacy Only: Prescription
Company:
MerckStatus:
UpdatedLegal 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
6363a4b5ec83e.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
63284013e10d3.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 - 22MCG PIL_1608032214.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_1608032012.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 22mcg Cart - Deletion of Rebislide_1599480657.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_1599480505.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.4 - Special precautions for storage
- 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
Deletion of non-marketed RebiSlide device from sections 4.2, 6.4 and 6.6 of the SPC TW2572377Deletion of non-marketed RebiSlide device from sections 4.2, 6.4 and 6.6.
Updated on 16 January 2020
File name
PIL - 22 MCG solution for injection in Cartridges_1579167301.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_1579094927.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 22cart - Pregnancy - 09-19 - TW2098021_1571692146.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_1571316308.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 24 July 2018
File name
Rebif 22 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 17 May 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 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_15309_755.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