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Organon Laboratories Limited
(Merck Sharp & Dohme Ireland (Human Health) Limited), P.O. Box 2857, Drynarn Road, Swords, Co Dublin, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 26/09/2011
SPC Pregnyl 5000

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 26/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   31-Mar-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


4.4       Special warnings and precautions for use

 

Text added:

 

“Patients on a controlled sodium diet:

This medicinal product contains less than 1 mmol sodium (23 mg) per daily dose, i.e. essentially ‘sodium-free’

 

 

10: Date of (partial) revision of the text

 

“March 2011”
Updated on 26/11/2009 and displayed until 26/09/2011
Reasons for adding or updating:
  • Change to marketing authorisation holder
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   16-Oct-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Change in the marketing authorisation holder resulting in the following updates to SPC sections:


7.         MARKETING AUTHORISATION HOLDER

 

NV Organon

Kloosterstraat 6

5349 AB Oss

The Netherlands

 

8.         MARKETING AUTHORISATION NUMBER

 

            PA 964/5/2


10.       DATE OF (PARTIAL) REVISION OF THE TEXT

            October 2009
Updated on 08/01/2009 and displayed until 26/11/2009
Reasons for adding or updating:
  • 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 4.5 - 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
  • Change to section 5 - Pharmacological 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
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

changes to pharmaceutical and medical sections of the SPC following harmonisation of  Pregnyl product information worldwide.
Updated on 08/01/2009 and displayed until 08/01/2009
Reasons for adding or updating:
  • 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 4.5 - 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
  • Change to section 5 - Pharmacological 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
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
changes to both pharmaceutical but mainly clinical sections of text resulting from a harmonisation of Pregnyl product information worldwide.
Updated on 08/08/2006 and displayed until 08/01/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 11/10/2004 and displayed until 08/08/2006
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 17/06/2003 and displayed until 11/10/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Human Chorionic Gonadotrophin