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Rebif Initiation Pack Solution for Injection in Pre-Filled Syringe

  • Name:

    Rebif Initiation Pack Solution for Injection in Pre-Filled Syringe

  • Company:
    info
  • Active Ingredients:

    Interferon beta-1a

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/12/20

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Summary of Product Characteristics last updated on medicines.ie: 15/12/2020

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Merck

Merck

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Medicine Name GONAL-f 450 IU (33 mcg) pen Active Ingredients Follitropin alpha
Medicine Name GONAL-f 450 IU (33 micrograms) Active Ingredients Follitropin alpha
Medicine Name GONAL-f 75 IU (5.5 micrograms) Active Ingredients Follitropin alpha
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Medicine Name MAVENCLAD 10 mg Tablets Active Ingredients Cladribine
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Medicine Name Praxilene Active Ingredients Naftidrofuryl Hydrogen Oxalate
Medicine Name Rebif 22 mcg Solution for Injection in Cartridge Active Ingredients Interferon beta-1a
Medicine Name Rebif 22 mcg Solution for Injection in Pre-Filled Syringe Active Ingredients Interferon beta-1a
Medicine Name Rebif 44 mcg Solution for Injection in Cartridge Active Ingredients Interferon beta-1a
Medicine Name Rebif 44 mcg Solution for Injection in Pre-Filled Syringe Active Ingredients Interferon beta-1a
Medicine Name Rebif Initiation Pack Solution for Injection in Cartridge Active Ingredients Interferon beta-1a
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 15 December 2020 PIL

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 SPC

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 PIL

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 SPC

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 PIL

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 SPC

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 25 July 2018 PIL

Reasons for updating

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

Updated on 25 July 2018 SPC

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 SPC

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 SPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 September 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 24 July 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 5 January 2015 PIL

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 PIL

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 PIL

Reasons for updating

  • Change to side-effects
  • Change to dosage and administration
  • Change of distributor details

Updated on 19 July 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 5 October 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 4 April 2012 PIL

Reasons for updating

  • New PIL for medicines.ie