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Nuvaring

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Updated on 21 June 2024

File name

NUVARING-NL-H-0265-001-PI-001-IE_MT-en_CRT June 24.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 16 September 2022

File name

Nuvaring-NL-H-0265-001-WS607-IB-SPC-IE-en-CRT.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Updated on 16 September 2022

File name

NUVARING-NL-H-0265-WS-607-PIL-IE_MT-en_CRT.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 29 September 2021

File name

QRD-IE_MT-NUVARING-LFT- MAT WS-538- CRT.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 29 September 2021

File name

Nuvaring-NL-H-0265-001-MAT-WS-IB-538 SPC-IE-en-CRT.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - 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)

Free text change information supplied by the pharmaceutical company

WS 538

Updated on 26 August 2021

File name

QRD-IE_MT-NUVARING-LFT- MAT Jul21- CRT.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 26 August 2021

File name

Nuvaring-NL-H-0265-001-MAT-SPC-IE-en-CRT.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 26 August 2021

File name

QRD-IE_MT-NUVARING-LFT- MAT Jul21- CRT.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 07 July 2020

File name

QRD-IE_MT-NUVARING-LFT-E004-EN CRT (002).pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Changes to section 6  Marketing Authorisation Holder:  Inclusion of MAH in MT   and  date of revision

 

Updated on 20 March 2019

File name

Nuvaring PIL WS-276 CRT.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 March 2019

File name

Nuvaring-NL-H-0265-001-WS 276-SPC-IE-en-CRT.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Inclusion of anaphylaxis and angioedema. Signal of suicidality with hormonal contraceptives.

Updated on 20 December 2018

File name

PIL WS-314.pdf

Reasons for updating

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

Updated on 20 December 2018

File name

SPC Ws 314.pdf

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Reports of ring breakage when using intravaginal products

Updated on 09 August 2018

File name

PIL WS-257 Final (2).pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 09 August 2018

File name

Nuvaring-NL-H-0265-001-WS-257-SPC-IE-en-CRT (2).pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

SPC change details: information on vaginal injury associated with ring breakage.

Updated on 10 May 2018

Reasons for updating

  • New SPC for new product

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

Updated on 06 September 2017

Reasons for updating

  • New SPC for new product

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

Updated on 06 September 2017

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
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

SPC change details: 4.2  Introduction of a co-packaged presentation.  Also, additional examples of barrier methods that should not be used with Nuvaring. 4.4: Information on Nuvaring removal if adhered to vaginal tissue. Also addition of ‘Male’ before condom for clarity. 4.5 Interactions with other medicines and other forms of interaction, to include additional examples of barrier methods that should not be used  4.8: Vaginal ring tissue overgrowth added to AE table. 6.5 Nature and contents of container, to include reference to the applicator . 6.6 Special precautions for disposal and other handling, to include reference to the applicator

Updated on 05 September 2017

File name

PIL_10015_277.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 September 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 15 May 2017

Reasons for updating

  • 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 4.5 - 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC change details: 4.2  Revision of existing instructions in SmPC and Package Leaflet for women to regularly check for the presence of the ring in the vagina. 4.3 HCV combination regimen as a contraindication, Update 4.4. & 4.5 regarding the co-administration of the Hepatitis C combination regimen with ethinylestradiol-containing products and the risk of elevated ALT.

Updated on 11 May 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • 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 6 - date of revision

Updated on 14 February 2017

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

SPC change details: Change to section 4.4 (Crohn’s disease).

Updated on 28 October 2016

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 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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



SPC change details: Deletion of interaction between broad spectrum antibiotics and COCs/Update on interactions with HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors/and update the RMP . Additional  environmental statements in 5.3 and 6.6  

Updated on 28 October 2016

Reasons for updating

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

Updated on 11 April 2016

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.2 Posology and method of administration, section 10, revision date

             SPC Change Details:  Addition of an optional applicator

Updated on 08 April 2016

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 12 March 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8:Undesirable effects - how to report a side effect
Update to the AE reporting statement

Updated on 12 March 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 10 July 2014

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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

Change to Section 7, MA holder, Section 8, PA number, Section 10 Date of revision

Updated on 08 July 2014

Reasons for updating

  • Change of licence holder

Updated on 21 May 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 - how to report a side effect
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to:  Section 4.1 Therapeutic indications, Section 4.3 Contraindications, Section 4.4 Special warnings and precautions for use, section 4.6 pregnancy & lactation, Section 4.8 Undesirable effects, Section 9, Renewal date, Section 10 , revision of text.

Updated on 20 May 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision

Updated on 28 March 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Change to:  Section 4.8 Undesirable effects - Type II Variation II WS 71.

Updated on 14 August 2013

Reasons for updating

  • Change to improve clarity and readability

Updated on 03 July 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

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

Free text change information supplied by the pharmaceutical company

Change to Sections:
4.2 Posology and method of administration
Section 4.4 Special warnings and precautions for use
Section 4.6 Fertility, Pregnancy and lactation

Section 4.8 Undesirable effects

Updated on 07 August 2012

Reasons for updating

  • Change to storage instructions

Updated on 19 June 2012

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Update to Section 9 - Date of renewal of authorisation.

Updated on 09 August 2010

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company



In section "4.4 Special warnings and special precautions for use", sub section 

2. Tumors, the wording of the Paragraph has changed from:

 “Some epidemiological studies indicate that the long-term use of oral contraceptives displays a risk factor for the development of cervical cancer in women infected with human papillomavirus (HPV). However, there is still controversy about the extent to which this finding is influenced by confounding effects (e.g. differences in number of sexual partners or in use of barrier contraceptives). No epidemiological data on the risk of cervical cancer in users of NuvaRing are available (see ‘medical examination/consultation’)”

to:

“Epidemiological studies indicate that the long-term use of oral contraceptives displays a risk factor for the development of cervical cancer in women infected with human papillomavirus (HPV). However, there is still uncertainty about the extent to which this finding is influenced by confounding effects (e.g. differences in number of sexual partners or in use of barrier contraceptives) No epidemiological data on the risk of cervical cancer in users of NuvaRing are available (see ‘medical examination/consultation’)”

 

 

3 Other conditions

  • Addition of sentence: “Very rarely it has been reported that the ring adhered to vaginal tissue, necessitating removal by a healthcare provider.”

4.8 Undesirable effects

  • Table heading changed from“Uncommon ³ 1/1000 to ≤1/100” to “Uncommon ³ 1/1000 to <1/100”
  • Deleted  “gential discharge”

Updated on 04 August 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 02 July 2008

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 06 June 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 1 Product name updated
Section 4.2 Administration information updated
Section 4.4 Clarification of wording
Section 4.5 Typographical error corrected
Section 4.8 Update to undesirable effects
Section 5.1 Update to efficacy data
Section 6.4 Wording revised                         
Section 6.5 Container information updated.
Section 6.6 Section title updated
Section 10 Date of revision of text updated

Updated on 06 June 2008

Reasons for updating

  • Change of trade or active ingredient name
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change due to harmonisation of patient information leaflet

Updated on 10 November 2006

Reasons for updating

  • Improved electronic presentation
  • Change of contraindications
  • Change to date of revision

Updated on 03 October 2006

Reasons for updating

  • Change of active ingredient
  • Change to dosage and administration
  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to date of revision

Updated on 30 August 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 1 - Updated product name
Section 4.2 - Revision of posology and method of administration instructions
Section 4.3 - Addition of new contraindications
Section 4.4 - Addition of special warnings and special precautions for use
Section 4.5 - Update to information on interaction with other medicinal products
Section 9 - Update to last renewal date
Section 10 - Date of Revision updated

Updated on 08 August 2006

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 4.2 - Additional information on posology and method of administration.
Seciton 4.4 - Update to precautions for use.
Section 4.6 - Revision of advice for pregnancy and lactation.
Section 4.8 - Revision of undesirable effects reported.
Section 5.2 - Update to pharmacokinetic properties.
Section 6.3 - Extension of Shelf-Life.
Seciton 6.4 - Amendment to storage precautions following extension of shelf-life.
Section 10 - Date of revision of text updated.

Updated on 27 June 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 June 2005

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 8 - MA number

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

Updated on 27 April 2004

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 02 February 2004

Reasons for updating

  • New SPC for medicines.ie

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