Ovitrelle 250 micrograms/0.5 ml pre-filled pen *
Pharmacy Only: Prescription

  • Company:

    Merck
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, 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 24 November 2021

File name

Ovitrelle PEN PIL IENI - Brexit and Needle - Current V9 - Nov 2021_1637766701.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

In section 6 - addition of second needle (Our reference: TW 2668182 )

In section 4 - update of United Kingdom to United Kingdom (Northern Ireland)

Updated on 24 November 2021

File name

Ovitrelle PEN IENI - Brexit and Needle - Current V9 - Oct 2021_1637766582.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.5 - Nature and contents of container
  • 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

In section 6.5 - addition of second needle (Our reference: TW 2668182 )

In section 4.8 - update of United Kingdom to United Kingdom (Northern Ireland)

EDM Updated on 16 November 2020

File name

IFU Pen_ TW2385848 v8.0 Clean_1605543612.pdf

Reasons for updating

  • Replace File

Updated on 16 November 2020

File name

PIL Pen_ TW2385848 v8.0 Clean_1605543572.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • 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 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 16 November 2020

File name

SPC Pen_ TW2385848 v8.0 Clean_1605543235.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 not be renewed (A)

EDM Updated on 22 August 2019

File name

Instructions For Use (emc)_1563355431.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Images have been updated.

Date revised to October 2018.

Updated on 01 November 2018

File name

Leaflet (MA Transfer + Safety combined)_1541063284.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 26 October 2018

File name

Ovitrelle_PEN_UK_ROI_TW1696603_current_V7.0_1540561698.pdf

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 not be renewed (A)

Updated on 02 October 2018

File name

Ovitrelle_PEN_UK_ROI_TW1735675_current_V6.0_1538472394.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Updated on 27 May 2018

File name

33266.docx

Reasons for updating

  • New SPC for new product

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

Updated on 15 May 2018

Reasons for updating

  • Other

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

EDM Updated on 26 April 2018

File name

Ovitrelle 250micrograms-0.5ml pre-filled pen -IFU.pdf

Reasons for updating

  • Add New Doc

Updated on 20 February 2017

File name

PIL_15323_744.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 February 2017

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section

Updated on 26 January 2017

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 6 - manufacturer

Updated on 19 December 2016

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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 - was updated with the addition of Malta. Internal Ref: TW1230178.

Updated on 19 December 2016

Reasons for updating

  • New SPC for new product

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

Updated on 02 August 2016

Reasons for updating

  • Change to further information section

Updated on 07 July 2015

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 29 May 2015

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

Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

Updated on 17 June 2014

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 13 May 2014

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

Minor editorial changes including information on the reporting of adverse reactions in Section 4.8.

Updated on 31 March 2014

Reasons for updating

  • Change of distributor details

Updated on 19 March 2013

Reasons for updating

  • Change of inactive ingredient
  • Change of distributor details

Updated on 14 January 2013

Reasons for updating

  • Change to section 6.1 - List of excipients
  • 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

6.       PHARMACEUTICAL PARTICULARS

 

6.1     List of excipients

 

Mannitol

Methionine

Disodium phosphate dihydrate

Sodium dihydrogen phosphate monohydrate

Poloxamer 188

Phosphoric acid (for pH adjustment)

Sodium hydroxide (for pH adjustment)

Water for injections

10.     DATE OF REVISION OF THE TEXT

 

12/2012


Updated on 10 April 2012

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 January 2012

Reasons for updating

  • Addition of separate SPCs covering individual presentations

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

Free text change information supplied by the pharmaceutical company

None provided