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Envarsus 0.75mg; 1mg; 4mg prolonged-release tablet

  • Name:

    Envarsus 0.75mg; 1mg; 4mg prolonged-release tablet

  • Company:
    info
  • Active Ingredients:

    Tacrolimus Monohydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/03/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 16/3/2020

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Chiesi Limited

Chiesi Limited

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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 16 March 2020 SPC

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 10 - Date of revision of the text

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

Updated on 16 March 2020 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 8 August 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 4 July 2019 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.4 - Inclusion of Eye Disorders

Section 10 - Date of revision - June 2019

Updated on 4 May 2018 Ed-HCP

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Envarsus Prolonged-release tacrolimus tablets Patient Card

Updated on 4 May 2018 Ed-HCP

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Educational materials for the healthcare professional (doctor or pharmacist) Please read the full Summary of Product Characteristics before prescribing Envarsus

Updated on 17 August 2016 PIL

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 17 August 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 June 2016 PIL

Reasons for updating

  • Change to date of revision
  • Addition of joint PIL covering all presentations

Updated on 20 April 2016 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 20 April 2016 SPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

Section 1 Name of the Medicinal Product - Envarsus 1 mg prolonged-release table

Envarsus 4 mg prolonged-release tablets has been added

Section 2 Qualitative and Quantitative composition - Envarsus 0.75 mg prolonged-release tablets,Envarsus 1 mg prolonged-release tablets Each prolonged-release tablet contains 1 mg tacrolimus (as monohydrate). Excipient with known effect: Each tablet contains 41.7 mg lactose (as monohydrate). Envarsus 4 mg prolonged-release tablets Each prolonged-release tablet contains 4 mg tacrolimus (as monohydrate). Excipient with known effect:  Each tablet contains 104 mg lactose (as monohydrate). Has been adde

Section 3 Pharmaceutical Form - 1 mg:

Oval, white to off-white uncoated tablet, debossed with “1” on one side and “TCS” on the other side. 4 mg:Oval, white to off-white uncoated tablet, debossed with “4” on one side and “TCS” on the other side. – has been added

Section 4.4 Special warnings and precautions - Envarsus is not recommended for use in children below 18 years of age due to the limited data on safety and/or efficacy. Has been removed

Paediatric population

Envarsus is not recommended for use in children below 18 years of age due to the limited data on safety and/or efficacy- has been added

Section 4.5 - Interaction with other medicinal products and other forms of interaction- Paediatric population

Interaction studies have only been performed in adults has been added

Section 4.8 - Reporting of suspected adverse reactions - in the UK, Website: at www.mhra.gov.uk/yellowcard or in Ireland to HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie. has been added

Section 5.1 Pharmacodynamic effect - new subheading has been added

Clinical efficacy and safety – new subheading has been added

Section 5.2 - Pharmacokinetic properties- Excretion changed to Elimination

Section 8 Marketing authorisation numbers(s) EU/1/14/935/001 changed to

0.75mg  EU/1/14/935/001 1mg  EU/1/14/935/004 4mg  EU/1/14/935/007

Section 9 - Date of first authorisation: added Section 10 – November 2014 changed to April 2016

 

Updated on 13 November 2015 PIL

Reasons for updating

  • Change to date of revision

Updated on 7 August 2015 SPC

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 4 August 2015 PIL

Reasons for updating

  • New PIL for new product