Rebif 44 mcg Solution for Injection in Pre-Filled Syringe * 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
SYRINGE - 44MCG PIL_1608031403.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 SYRINGES - UK and IE - Current - SPCv13 - TW2704494 - CLEAN_1608031285.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 - 44 MCG solution for injection in pre-filled syringe_1579167505.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_1579096084.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 44mcgpfs12 - Pregnancy - 09-19 - TW2098021_1571692435.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_1571318663.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 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 (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_pre_filled_syringes_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 23 January 2018
File name
PIL_15313_962.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