Ovitrelle 250 micrograms/0.5 ml pre-filled pen

  • Name:

    Ovitrelle 250 micrograms/0.5 ml pre-filled pen

  • Company:
    info
  • Active Ingredients:

    Choriogonadotropin alfa

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/11/18

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Summary of Product Characteristics last updated on medicines.ie: 26/10/2018

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Merck

Merck

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Medicine Name MAVENCLAD 10 mg Tablets Active Ingredients Cladribine
Medicine Name Ovitrelle 250 micrograms/0.5 ml pre-filled pen Active Ingredients Choriogonadotropin alfa
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Medicine Name Rebif 22 mcg Solution for Injection in Cartridge Active Ingredients Interferon beta-1a
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Medicine Name Rebif 44 mcg Solution for Injection in Pre-Filled Pen Active Ingredients Interferon beta-1a
1 - 0 of 32 items.Total: Infinity pages

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 22 August 2019 Ed-HCP

Reasons for updating

  • Replace document

Free text change information supplied by the pharmaceutical company

Images have been updated.

Date revised to October 2018.

Updated on 1 November 2018 PIL

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 SmPC

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 2 October 2018 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 15 May 2018 SmPC

Reasons for updating

  • Other

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

Updated on 26 April 2018 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 20 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 February 2017 PIL

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 PIL

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 19 December 2016 SmPC

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 2 August 2016 PIL

Reasons for updating

  • Change to further information section

Updated on 7 July 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 29 May 2015 SmPC

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 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 13 May 2014 SmPC

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 PIL

Reasons for updating

  • Change of distributor details

Updated on 19 March 2013 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change of distributor details

Updated on 14 January 2013 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 January 2012 SmPC

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