Moderiba 400mg Film-coated Tablets

  • Name:

    Moderiba 400mg Film-coated Tablets

  • Company:
    info
  • Active Ingredients:

    Ribavirin

  • 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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Summary of Product Characteristics last updated on medicines.ie: 18/7/2018

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AbbVie Limited

AbbVie Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Chirocaine 1.25mg/ml solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 2.5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Chirocaine 7.5 mg/ml solution for injection/concentrate for solution for infusion Active Ingredients levobupivacaine hydrochloride
Medicine Name Duodopa intestinal gel Active Ingredients Carbidopa Monohydrate, Levodopa
Medicine Name Forane 99.9% w/w, inhalation vapour liquid Active Ingredients Isoflurane
Medicine Name Moderiba 200mg Film-coated Tablets Active Ingredients Ribavirin
Medicine Name Moderiba 400mg Film-coated Tablets Active Ingredients Ribavirin
Medicine Name Moderiba 600mg Film-coated Tablets Active Ingredients Ribavirin
Medicine Name Sevorane Active Ingredients Sevoflurane
Medicine Name Zemplar 5 microgram/ml Solution for Injection Active Ingredients Paricalcitol
Medicine Name Zemplar capsules, soft Active Ingredients Paricalcitol
1 - 0 of 12 items.Total: Infinity pages

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

Update MAH contact details from

 
Present:

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

Section 3:
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

None provided

Updated on 26 August 2014 PIL

Reasons for updating

  • New PIL for new product