Maviret 100 mg-40 mg film-coated tablets

  • Name:

    Maviret 100 mg-40 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Glecaprevir, Pibrentasvir

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/04/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 3/2/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

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 Humira 20 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Humira 40 mg solution for injection in pre-filled syringe Active Ingredients adalimumab
Medicine Name Humira 40mg solution for injection in pre-filled pen Active Ingredients adalimumab
Medicine Name Humira 80 mg solution for injection in pre-filled pen Active Ingredients adalimumab
Medicine Name Kaletra 200 mg/50 mg film-coated tablets Active Ingredients Lopinavir, Ritonavir
Medicine Name Kaletra oral solution Active Ingredients Lopinavir, Ritonavir
Medicine Name Maviret 100 mg-40 mg film-coated tablets Active Ingredients Glecaprevir, Pibrentasvir
Medicine Name Norvir 100 mg powder for oral suspension Active Ingredients Ritonavir
Medicine Name Norvir 100mg Film-coated Tablets Active Ingredients Ritonavir
Medicine Name RINVOQ 15 mg prolonged-release tablets Active Ingredients Upadacitinib
Medicine Name Sevorane Active Ingredients Sevoflurane
Medicine Name Skyrizi 75 mg solution for injection in pre-filled syringe Active Ingredients Risankizumab
Medicine Name Synagis Solution for Injection Active Ingredients Palivizumab
Medicine Name Venclyxto 10mg, 50mg and 100mg Film-coated Tablets Active Ingredients Venetoclax
Medicine Name Zemplar 5 microgram/ml Solution for Injection Active Ingredients Paricalcitol
Medicine Name Zemplar capsules, soft Active Ingredients Paricalcitol
1 - 0 of 22 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 3 February 2020 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Updated on 23 September 2019 SmPC

Reasons for updating

  • 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)

Updated on 29 July 2019 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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)

Updated on 29 April 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 15 April 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • 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 20 March 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to date of revision

Updated on 20 March 2019 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 26 February 2019 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 3 December 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 3 December 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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 20 June 2018 SmPC

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)

Free text change information supplied by the pharmaceutical company

Description of change

 

SmPC was updated to reflect approval of Type IB variation to transfer EU MA from UK to Germany due to Brexit for Maviret 100 mg/40 mg film-coated tablets.

 

The following is summary of the changes:

 

7.       Marketing Authorisation Holder

Updated to AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany

 

10.       Date of Revision of Text

Updated to 06/2018.

Updated on 20 June 2018 PIL

Reasons for updating

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

Updated on 18 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 Type II variation to include dosing and administration for patients who are liver or kidney transplant recipient based on additional data gathered during the transplant study (M13-596) for Maviret 100 mg/40 mg Film-coated Tablets.

 

The following is summary of the changes:

 

4.2     Posology and method of administration

Update to to include dosing and administration for patients who are liver or kidney transplant recipient.

 

4.4     Special warnings and precautions for use

Removed section on liver transplant patients.

 

4.5       Interaction with other medicinal products and other forms of interaction

Updated wording on HCV-infected transplant recipients under Table 3: Interactions between Maviret and other medicinal products.

 

4.8     Undesirable effects

Added section on Adverse Reactions in Subjects with Liver or Kidney Transplant.

 

5.1       Pharmacodynamic properties

Updated Table 7: Clinical studies conducted with Maviret in subjects with HCV genotype 1, 2, 3, 4, 5 or 6 Infection with Liver or Kidney Transplant Recipients Study MAGELLAN-2.

Added Section on Clinical Study in Liver or Kidney Transplant Recipients.

 

10.       Date of Revision of Text

Updated to 04/2018.

 

Updated on 4 May 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 1 March 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision
  • Addition of information on alternative format leaflets

Updated on 1 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 March 2018 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Section 4.5 Interaction with other medicinal products and other forms of interaction

Ø  Table 3: Interactions between Maviret and other medicinal products, Proton Pump Inhibitors:

“Co-administration of Maviret with omeprazole 40 mg once daily may lead to reduced therapeutic effect and is not recommended” has been amended to  “No dose adjustment is required.”

 

 

Section 5.1          Pharmacodynamic properties

Ø  ATC code has been added:
J05AP57 glecaprevir and pibrentasvir

Ø  Minor editorial updates made to Table 7: Clinical studies conducted with Maviret in subjects with HCV genotype 1, 2, 3, 4, 5 or 6 Infection

 

Section 10.  DATE OF REVISION OF THE TEXT

Ø  Updated to 02/2018

Updated on 1 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 20 December 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

$0Description of change$0$0 $0$0SmPC was updated to reflect approval of Type II variation M14-730 HIVco-infection for Maviret 100 mg/40 mg Film-coated Tablets$0$0 $0$0The following is summary of the changes:$0$0 $0$04.4       Special warnings andprecautions for use$0$0Addition of full stop (dot) at theend of sentence under drug-drug interactions heading.$0$0 $0$04.5       Interaction with othermedicinal products and other forms of interaction$0$0Updated Table 3: Interactions betweenMaviret and other medicinal products.$0$0 $0$04.8       Undesirable effects$0$0Added information on Safety inHCV/HIV-1 Co-infected. $0$0 $0$05.1       Pharmacodynamic properties$0$0Extensive update toinclude study results for HIV-coinfection.$0$05.2       Pharmacokinetic properties$0$0Update to linearity/non-linearity.$0$0 $0$05.3       Preclinical safety data$0$0Minor typo correction. $0$0 $0$010.       Date of Revision of Text$0$0Updated to 12/2017.$0$0 $0

Updated on 9 August 2017 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 2 August 2017 PIL

Reasons for updating

  • New PIL for new product