Zoely 2.5 mg/1.5 mg film-coated tablets
*Company:
Theramex Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 11 January 2022
File name
Zoely PIL Dec 2021.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to date of revision
Updated on 11 January 2022
File name
Zoely SmPC Dec 2021.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- 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
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 June 2021
File name
Zoely PIL.pdf
Reasons for updating
- Change to date of revision
Updated on 17 June 2021
File name
Zoely SmPC.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 July 2020
File name
Zoely SmPC.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 July 2020
File name
Zoely PIL.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change of contraindications
Updated on 27 February 2019
File name
QRD-ZOELY-H-C-001213-T-047-IE-MT-PIL.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 27 February 2019
File name
ZOELY-H-C-001213-T-047-SPC-en-CRT.pdf
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 08 February 2019
File name
ZOELY-H-C-1213-IA-IN-0048-PIL-en-CRT.pdf
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 08 February 2019
File name
ZOELY-H-C-1213-IA-IN-0048-SPC-en-CRT.pdf
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
File name
PIL_15258_699.pdf
Reasons for updating
- New PIL for new product
Updated on 16 January 2018
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 28 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 March 2017
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
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
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
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
Updated on 06 May 2016
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
Updated on 06 May 2016
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 23 June 2015
Reasons for updating
- Change to instructions about missed dose
- Change to date of revision
Updated on 28 May 2015
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
Updated on 12 September 2014
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
- Addition of information on reporting a side effect.
Updated on 09 September 2014
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
Updated on 18 February 2014
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
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 03 February 2014
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
Reasons for updating
- Change to date of revision
- Addition of black triangle
Updated on 04 November 2013
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
Updated on 14 August 2013
Reasons for updating
- Change to improve clarity and readability
Updated on 18 June 2013
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 05 October 2012
Reasons for updating
- Addition of manufacturer
- Introduction of new pack/pack size
Updated on 10 July 2012
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
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
Updated on 25 January 2012
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
Updated on 24 January 2012
Reasons for updating
- New PIL for new product