go to medicines.ie homepage
Font Size
Search for:  
select
  Advanced Search

Organon Laboratories Limited
(Merck Sharp & Dohme Ireland (Human Health) Limited), P.O. Box 2857, Drynarn Road, Swords, Co Dublin, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 09/08/2010
SPC Nuvaring

When a pharmaceutical company changes an SPC or PIL, 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 09/08/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   31-Oct-2009
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 02/07/2008 and displayed until 09/08/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 06/06/2008 and displayed until 02/07/2008
Reasons for adding or 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
Date of revision of text on the SPC:   03/2008
Legal Category:   prescription only

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 30/08/2006 and displayed until 06/06/2008
Reasons for adding or 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
Date of revision of text on the SPC:   08/2006
Legal Category:   prescription only

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 08/08/2006 and displayed until 30/08/2006
Reasons for adding or 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
Date of revision of text on the SPC:   03/2006
Legal Category:   prescription only

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 23/06/2005 and displayed until 08/08/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 8 - MA number
Updated on 27/04/2004 and displayed until 23/06/2005
Reasons for adding or 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
Updated on 02/02/2004 and displayed until 27/04/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
  Ethinyloestradiol
  Etonogestrel