Marviol *
Pharmacy Only: Prescription

Updated on 20 September 2022

File name

6329c21bbf9bb.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 be renewed (B)

Updated on 20 September 2022

File name

6329c1a8d57e6.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 26 August 2021

File name

QRD_Marviol_PIL_PRAC and MAT combined July 2021_IE_CRT_1629979049.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation number

Updated on 26 August 2021

File name

IE-MARVIOL-EN-SPC-MAT-20210730-CRT_1629978994.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 14 July 2021

File name

IE-MARVIOL-EN-SPC-PRAC-20210628-CRT_1626261094.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 - 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

To implement the outcome of PSUSA/00001307/202007

Updated on 14 July 2021

File name

QRD_marviol_PIL_PRAC June 2021_IE_CRT_1626260870.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 23 April 2019

File name

marviol_PIL_QRD_PRAC_CRT_1556021493.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 23 April 2019

File name

IE-MARVIOL-EN-SPC-PRAC-CRT_1556021928.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: addition of safety warning for increased risk of suicidality with hormonal contraceptives

 

Updated on 23 January 2019

File name

marviol_PIL_QRD_TypeIA_Removal Organon Swords_1548253230.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 14 January 2019

File name

marviol_PIL_QRD_Deletion Organon DPM_JAN 2019_CRT_1547479006.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 10 May 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 31 July 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 31 July 2017

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 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 4.3;4.4; 4.5: addition of contraindication with products containing ombitasvir/paritaprevir/ritonavir and dasabuvir;

Updated on 28 July 2017

File name

PIL_9777_469.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 July 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 25 April 2017

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 19 April 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 5.2 - Pharmacokinetic properties
  • 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

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 March 2015

Reasons for updating

  • 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

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 03 February 2015

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 11 June 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 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 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 10 June 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change due to harmonisation of PIL

Updated on 06 June 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to date of revision

Updated on 23 May 2013

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 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

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 July 2011

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 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

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 13 May 2011

Reasons for updating

  • Change to improve clarity and readability

Updated on 25 March 2009

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 14 August 2008

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

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 14 August 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 31 July 2006

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

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 23 May 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 04 June 2004

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)