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Suprecur 150 micrograms/metered dose Nasal Spray, solution

  • Name:

    Suprecur 150 micrograms/metered dose Nasal Spray, solution

  • Company:
    info
  • Active Ingredients:

    Buserelin Acetate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/04/17

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Summary of Product Characteristics last updated on medicines.ie: 27/4/2017
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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 27 April 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 27 April 2017 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

T1A IN B.II.e.5 - The variation concerns an update to the pack presentation on the market to change from a bundled pack of 2 to a single pack. This change requires an update to section 6.5 of the SPC and section 6 of the PIL. The change does not impact the dosing instructions and treatment duration, nor does it impact the stability studies. 

Updated on 24 April 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 April 2017 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder

Updated on 10 February 2016 PIL

Reasons for updating

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

Updated on 1 September 2015 SmPC

Reasons for updating

  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Cardiac disorders: palpitations.  Frequency unknown/rare/uncommon*: QT prolongation (see sections 4.4 and 4.5)   

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

Free text change information supplied by the pharmaceutical company

Section 4.4

Androgen deprivation therapy may prolong the QT interval.

In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Suprecur.

Section 4.5

 

Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Suprecur with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated (see section 4.4).

Section 4.8

  • Cardiac disorders: palpitations.  Frequency unknown/rare/uncommon*: QT prolongation (see sections 4.4 and 4.5)   

*frequency as derived from clinical trials/safety studies, if no data is available frequency should be labelled as “unknown”.


Updated on 13 December 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 10 September 2013 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

T1B C.1.3.a bulk variation application: Class effect of Gonadotropin-releasing hormone agonists (buserelin, nafarelin, triptorelin) on depression.

Updated on 5 September 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to warnings or special precautions for use

Updated on 13 April 2012 SmPC

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Updated in line with Company Core Data Sheet version 7:-

Section 4.2 - includes a new paragraph regarding the administration of individual doses

Section 4.4 - 3 paragraph has been slightly reworded with addition of information on bone mineral density.  New paragraphs 5&6 regarding published epidemiological studies and the relationship between gonadotropin releasing hormone and the increased risk of cardiovascular disease.

Section 4.6 - 'Fertility' added to heading

Section 4.8 - Removed reference to rare cases of migraine in women

5.1 - ATC code added

9 - Updated in line with the QRD template

Updated on 13 March 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 25 March 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 21 July 2010 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company



Section 4.2 posology and method of administration - update to wording of text

Section 4.9 Overdose - update to wording of text

Updated on 18 May 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Section 2: Excipients
Section 6.1: List of Excipients
Section 6.5: Nature and contents of container

Updated on 13 May 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 26 August 2009 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Correction of minor typographical errors.

Updated on 17 August 2009 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 28 October 2008 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Update section 6.5 of SPC.
 

Updated on 21 August 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 21 March 2007 SmPC

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Update
Section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Section 10 - Date of Revision

Updated on 28 August 2006 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Update Section 9. - Date of renewal of authorisation.

Updated on 27 September 2004 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 January 2004 SmPC

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 4.6 - Pregnancy and lactation
  • 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 12 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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