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Adenocor

*
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Adenosine

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

Updated on 12 October 2023

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Adenocor.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 12 October 2023

File name

1.3.1.3 Package Leaflet (PIL text) Adenocor.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Correction of spelling/typing errors

Updated on 20 December 2021

File name

ie-adenocor- PIL text - clean.pdf

Reasons for updating

  • 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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings

Updated on 17 December 2021

File name

ie-adenocor-SPC-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

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

Updated on 12 July 2021

File name

PIL_9173_858.pdf

Reasons for updating

  • XPIL Removed

Updated on 06 July 2020

File name

PIL_9173_858.pdf

Reasons for updating

  • XPIL Removed

Updated on 02 June 2015

Reasons for updating

  • New SPC for new product

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

Updated on 02 June 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 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

File name

PIL_9173_858.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 May 2015

Reasons for updating

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

Updated on 16 May 2014

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 08 May 2014

Reasons for updating

  • Change to side-effects

Updated on 24 October 2013

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

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

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

Reasons for updating

  • Change to storage instructions

Updated on 26 September 2012

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

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

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

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 03 November 2009

Reasons for updating

  • Change of manufacturer

Updated on 20 August 2008

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 20 August 2008

Reasons for updating

  • Improved electronic presentation

Updated on 24 July 2008

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

Reasons for updating

  • Improved electronic presentation

Updated on 17 May 2005

Reasons for updating

  • Improved electronic presentation

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

Updated on 22 October 2004

Reasons for updating

  • New PIL for new product

Updated on 03 August 2004

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 01 July 2003

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

Reasons for updating

  • New SPC for new product

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