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Adenocor

  • Name:

    Adenocor

  • Company:
    info
  • Active Ingredients:

    Adenosine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 2/6/2015
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SANOFI

SANOFI

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1 - 0 of 178 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 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 2 June 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 2 June 2015 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)

Free text change information supplied by the pharmaceutical company

Section 4.8: updated to add the following under 'Vascular disorders':

Not known:    

-hypotension sometimes severe

-cerebrovascular accident/transient ischemic attack,(See section 4.4 Special Warnings and Precautions for Use)


- Hypotension sometimes severe has been moved from under 'Cardiac disorders'.

Updated on 28 May 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 May 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 16 May 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Type II.C.1.4 variation application applicable to update Section 4.8 of the SPC following a revision to our Company Core Safety Data Sheet for Adenosine – CCDSv7.

Updated on 8 May 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 24 October 2013 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Type IA IN .C.1.3.a) variation concerning the finalization of an Article 45 paediatric assessment for Adenosine – UK/W/040/pdWS001 following which the SPC and product labeling are updated.

Updated on 23 October 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 10 September 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

Section 6.3: shelf life reduced from 36 months to 24 months.
Section 6.4: Store below 25°C.

Updated on 30 August 2013 PIL

Reasons for updating

  • Change to storage instructions

Updated on 26 September 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Section 7 updated to included 'T/A SANOFI'

Updated on 20 September 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to marketing authorisation holder

Updated on 17 September 2012 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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

Type IB to update the SPC in accordance with the CSP.

Updated on 15 April 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.2 - Incompatibilities

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

Free text change information supplied by the pharmaceutical company

Update Section 2 details of excipients
Update Section 6.2 additional information

Updated on 3 November 2009 PIL

Reasons for updating

  • Change of manufacturer

Updated on 20 August 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 20 August 2008 SmPC

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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

Update sections
4.3, 4.4, 4.5, 4.6, 4.8 and 4.9

Updated on 24 July 2008 SmPC

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update section 7, 8 and 10.

Updated on 18 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 17 May 2005 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 22 October 2004 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 August 2004 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)

Updated on 1 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for new product

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