Moderiba 400mg Film-coated Tablets
- Name:
Moderiba 400mg Film-coated Tablets
- Company:
AbbVie Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/06/18
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AbbVie Limited
Company Products
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 18 July 2018 SmPC
Reasons for updating
- File format updated to PDF
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 18 July 2018 SmPC
Reasons for updating
- File format updated to PDF
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 5 June 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 29 May 2018 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
Description of change
SmPC was updated to reflect approval of V24 – addition of ADR tongue pigmentation to PL.
The following is summary of the changes:
Section 4.2 Posology and method of administration
Correction of minor typo error.
Section 4.4 Special warnings and precautions for use
Minor correction to the Lactose section.
Section 4.8 Undesirable effects
Removed “tinnitus” from section on Chronic hepatitis C and Human Immunodeficiency Virus co-infection
Minor update to the wording in Table 4. Undesirable Effects Reported with ribavirin primarily in Combination with Peginterferon alfa-2a or Interferon alfa-2a for HCV Patients by Body System
Section 5.1 Pharmacodynamic properties
Minor typo correction.
Section 10 – Date of Revision of Text
Updated to May 2018.
Updated on 21 March 2016 SmPC
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
|
AbbVie Limited Block B Liffey Valley Office Campus Quarryvale Co. Dublin
|
Proposed: AbbVie Limited Citywest Business Campus Dublin 24 Ireland |
Updated on 21 March 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 March 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 21 March 2016 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 18 January 2016 PIL
Reasons for updating
- Addition of manufacturer
Updated on 14 January 2016 SmPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic 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
Addition of dimensions of tablet.
Section 4.1 - 4.8:
Updating indication for use of Moderiba in combination with other medicinal products for the treatment of chronic CHC. Removal of reference to use of Moderiba in combination with PEG-IFN alpha 2a
Section 10:
Update date of revision to January 2016
Updated on 13 January 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to drug interactions
- Change to information about driving or using machinery
- Change to date of revision
- Changes to therapeutic indications
Updated on 30 October 2015 PIL
Reasons for updating
- Change of manufacturer
Updated on 2 September 2014 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 26 August 2014 PIL
Reasons for updating
- New PIL for new product