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Takeda UK Ltd
Takeda House, Mercury Park, Wooburn Green, High Wycombe, HP10 0HH, UK
Telephone: +44 (0)1628 537 900
Fax: +44 (0)1628 526 615
Medical Information e-mail: medinfo@takeda.co.uk
Medical Information Facsimile: +44 (0)1628 526 617
Summary of Product Characteristics last updated on medicines.ie: 02/03/2010
SPC PROSTAP 3

When a pharmaceutical company changes an SPC or PIL, 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 02/03/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   28-Aug-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


In section 4.8 (undesirable effects), Orchiatrophy and gynaecomastia have been reported occasionally, has been added
Updated on 27/07/2009 and displayed until 02/03/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details
Date of revision of text on the SPC:   30-Jun-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


7.         MARKETING AUTHORISATION HOLDER

 

Takeda UK Limited

Takeda House

Mercury Park

Wooburn Green

High Wycombe

Bucks. HP10 0HH

UK

 

 

 8.        MARKETING AUTHORISATION NUMBER

 

            PA 1547/3/2

  

 

10.       DATE OF PREPARATION/REVISION OF TEXT

 

            30 June 2009
Updated on 29/04/2009 and displayed until 27/07/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   17-Apr-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Section 2.0 – the addition of a new statement with regard to the sodium content.

Section 4.8- the addition of a new statement in section ‘Undesirable Effects : “Very rare cases of pituitary apoplexy have been reported following initial administration in patients with pituitary adenoma” which replaces the current statement.

 

Section 6.4, the addition of a new statement “in order to protect from light”.
Updated on 29/10/2008 and displayed until 29/04/2009
Reasons for adding or updating:
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   04/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 6.6 - addiation of "or intramuscular injection"
Section 10 - update to date of revision
Updated on 10/06/2008 and displayed until 29/10/2008
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Date of revision of text on the SPC:   04/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
In Section 1 - the word - prolonged-release - has been added.
Updated on 14/01/2005 and displayed until 10/06/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 19/08/2004 and displayed until 14/01/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 09/08/2004 and displayed until 19/08/2004
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical safety data
Updated on 26/05/2004 and displayed until 09/08/2004
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
Updated on 16/12/2003 and displayed until 26/05/2004
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
Updated on 09/06/2003 and displayed until 16/12/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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  Leuprorelin Acetate