Zoely 2.5 mg/1.5 mg film-coated tablets

  • Name:

    Zoely 2.5 mg/1.5 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Estradiol Hemihydrate, Nomegestrol Acetate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/02/19

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Summary of Product Characteristics last updated on medicines.ie: 27/2/2019
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.

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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1 - 0 of 84 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 27 February 2019 PIL

Reasons for updating

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

Updated on 27 February 2019 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 7 - Marketing authorisation holder

Change to section 10 - Date of revision of the text

 

Updated on 8 February 2019 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 8 February 2019 SmPC

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.4 - Special warnings and precautions for use

Change to section 10 - Date of revision of the text

 

Updated on 16 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 January 2018 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 28 March 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 28 March 2017 SmPC

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.4, 4.5 (Update concerning interactions with concomitant medications and risk of reduced efficacy. Update concerning Hepatitis C and the risk of elevated ALT due to treatment with the HCV combination regimen ombitasvir/paritaprevir/ritonavir co-administered with ethinylestradiol-containing products.)

Updated on 27 March 2017 PIL

Reasons for updating

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

Updated on 26 October 2016 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Updated on 25 October 2016 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 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Detailed SPC change information: updates to sections 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 9 Date of renewal and 10 Date of revision of the text following approval of EMEA/H/C/001213/II/0035 (Update PI with IBD [Crohn's disease and Ulcerative Colitis])

Updated on 6 May 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 6 May 2016 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Detailed SPC change information: Updates to sections 4.1 Indications, 4.7 Effects on the ability to drive and use machines, 4.8 Undesirable effects, 5.1 pharmacodynamic properties, 6.1 list of excipients, 9 Date of renewal, 10 Date of revision of the text and other minor formatting updates following the approval of a Renewal

Updated on 23 June 2015 PIL

Reasons for updating

  • Change to instructions about missed dose
  • Change to date of revision

Updated on 28 May 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

sections 4.2 Posology and method of administration and section 10 date of revision.

Updated on 12 September 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Addition of information on reporting a side effect.

Updated on 9 September 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

T/003: MAH transfer from Theramex to Teva.

Updated on 18 February 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 14 February 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 3 February 2014 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Detailed SPC change information:
Updates to sections 4.1, 4.3, 4.4, 4.6, 4.8 and 10 due to an Article 31 Referral for Combined Hormonal Contraceptives

Updated on 11 December 2013 PIL

Reasons for updating

  • Change to date of revision
  • Addition of black triangle

Updated on 4 November 2013 SmPC

Reasons for updating

  • Addition of black triangle
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of Black Triangle and updates to Section 4.8 Undesireable effects

Updated on 14 August 2013 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 18 June 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 Undesireable effects - QRD and PSUR update

Updated on 5 October 2012 PIL

Reasons for updating

  • Addition of manufacturer
  • Introduction of new pack/pack size

Updated on 10 July 2012 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to Section 6.5: Nature and contents of container - Additional Pack Size

Updated on 26 January 2012 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to Date of Revision

Updated on 25 January 2012 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 24 January 2012 PIL

Reasons for updating

  • New PIL for new product