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MSD Ireland (Human Health) Limited

Red Oak North, South County Business Park, Leopardstown, Dublin 18, 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: 31/07/2017
SPC Marviol

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 31/07/2017 and displayed until Current
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 10 - Date of revision of the text
Date of revision of text on the SPC:   19-Jul-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change to section 4.3;4.4; 4.5: addition of contraindication with products containing ombitasvir/paritaprevir/ritonavir and dasabuvir;
Updated on 19/04/2017 and displayed until 31/07/2017
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07-Apr-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Updates to sections 4.2, 4.4, 4.5, 4.8, 5.2 and 10 as a result of approval of Type II variation to update Drug interaction information (SE/H/XXXX/WS/143)
Updated on 03/03/2015 and displayed until 19/04/2017
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   25-Feb-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.8 – Undesirable effects and section 10 date of revision

Updates to sections 4.8 and 10 to update the AE reporting text in the SPC


Updated on 11/06/2014 and displayed until 03/03/2015
Reasons for adding or 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 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   26-May-2014
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, 7, 8 and 10 due to an Article 31 Referral for Combined Hormonal Contraceptives, Type IB C.1.3.A - Variation to remove contraindication for use in pregnancy & MAH Transfer from Organon to MSD

Updated on 23/05/2013 and displayed until 11/06/2014
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 4.7 - 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 5.2 - Pharmacokinetic properties
  • 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
Date of revision of text on the SPC:   16-May-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Updates to sections:  4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 5.2, 5.3, 6.6 and 10.
Updated on 19/07/2011 and displayed until 23/05/2013
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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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:   31-Jan-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Change to section 4.2 - 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 4.8 - Undesirable effects

 Change to section 5.1 - Pharmacodynamic properties

Change to section 9 - Date of first authorisation/Renewal of  authorisation

 Change to section 10 - Date of revision of the text

Updated on 25/03/2009 and displayed until 19/07/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 14/08/2008 and displayed until 25/03/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 5 - Pharmacological properties
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 2- slight re-wording of text
Section 3- slight re-wording of text
Section 4- all clinical sections amended to include uptodate information inline with company core data sheet
Section 5- all clinical sections amended to include uptodate information inline with company core data sheet
Section 6- slight re-wording of text
Section 10- date of revision of text updated
Updated on 31/07/2006 and displayed until 14/08/2008
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01/2004
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 9 - update to date of renewal of the authorisation 
 
Correction of typographical error (section 4.8)
Updated on 04/06/2004 and displayed until 31/07/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 10 - Date of revision of the text
Updated on 20/06/2003 and displayed until 04/06/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Ethinylestradiol
   Desogestrel