Rebif 22 mcg Solution for Injection in Cartridge * Pharmacy Only: Prescription
Company:
MerckStatus:
No Recent UpdateLegal 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 - 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