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Wyeth Pharmaceuticals
Wyeth is now a wholly owned subsidary of Pfizer Inc, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 4676500
Fax: +353 1 4676501
Medical Information Direct Line: 1800 633 363
Summary of Product Characteristics last updated on medicines.ie: 19/05/2011
SPC Ovranette 150micrograms/30micrograms Coated Tablets

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 19/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 8 - MA number
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   01-May-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
MAH address change in section 7, PA number change section 8.
Updated on 04/02/2011 and displayed until 19/05/2011
Reasons for adding or updating:
  • Change to section 4 - Clinical particulars
Date of revision of text on the SPC:   01-Jan-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
There are several changes to section 4 of the SPC
Updated on 02/02/2010 and displayed until 04/02/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • 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:   27-Nov-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 1 - the strength of each of the active ingredients has been added to the trade name

Section 9 - the renewal date has been updated

Section 10 - the date of revision has been updated
Updated on 26/03/2009 and displayed until 02/02/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 2 - addition of excipient information
Section 3 - update to tablet description to include the new tablet colour
Section 6.1 - update to excipients
Section 10 - update to date of revision
Updated on 29/10/2008 and displayed until 26/03/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 2: Addition of excipient information
Section 6.1: Addition of full list of excipients
Section 10: Update to date of revision
Updated on 23/08/2007 and displayed until 29/10/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 6.1 - Removal of excipient that had been listed twice
Updated on 30/10/2006 and displayed until 23/08/2007
Reasons for adding or 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 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.3
 
Addition of 'aura'  to list of contraindications
 
Section 4.4
 
WARNINGS
Deletion of 'Certain inherited and acquired thrombophilias' in a. Myocardial Infarction of  1. Thromboembolic Disorders and Other Vascular Problems
 
Addition of 'Transient ischaemic attacks have also been associated with oral contraceptive use.' in c. Cerebrovascular Disease under
1. Thromboembolic Disorders and Other Vascular Problems
 
PRECAUTIONS FOR USE
 
New text added to

2. Lipid Disorders
'A small proportion of women will have adverse lipid changes while taking oral contraceptives.  Persistent hyperglyceridemia  may occur in a small proportion of COC users. Elevations of plasma triglycerides may lead to pancreatitis and other complications.'
 
and
 
'Nonhormonal contraception should be considered in women with uncontrolled dyslipidemias (see WARNINGS).'
 
 Section 4.5
 
Additon of 'Atorvastatin' and 'Substances that inhibit cytochrome P450 isoenzymes, such as indinavir, fluconazole and troleandomycin' to examples of substances that may increase serum EE concentrations
 
cyclosporine changed to ciclosporin
 
Section 4.9
 
Section revised to read  "Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote, and further treatment of overdose, if necessary, is directed to the symptoms."
 
Updated on 22/07/2005 and displayed until 30/10/2006
Reasons for adding or 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Updated on 23/02/2004 and displayed until 22/07/2005
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life
Updated on 03/12/2003 and displayed until 23/02/2004
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Updated on 09/06/2003 and displayed until 03/12/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Ethinyloestradiol
  Levonorgestrel