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Paines & Byrne Limited

Paines & Byrne Limited
3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH, UK
Telephone: +44 (0)1784 419 615
Fax: +44 (0)1784 419 583
Summary of Product Characteristics last updated on medicines.ie: 19/04/2011
SPC Ketovite Tablets

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 19/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   13-Dec-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company



In section 7 the address of the MAH, Paines and Byrne Limited, has been updated following a move to new premises.  This entails the address changing from Lovett House, Lovett Road, Staines, TW18 3AZ, United Kingdom to 3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH, United Kingdom.

 

In section 10 the last revision date of the text has been revised to correspond with this move to new premises as detailed in Section 7.  This date is updated to 13th December 2010.

Updated on 04/09/2009 and displayed until 19/04/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03-Jul-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company



Section 2:
Amendment to excipient name - alpha-tocopheryl acetate

Section 6.1
Lower-case "m" for magnesium

Section 6.4:
Amendment to storage condition - "Store in a refrigerator..."

Section 6.5
Following sentence added:
Not all pack sizes marketed.

Section 6.6
Change to heading

Section 9 & 10
Updating dates.

 

 

 

Updated on 21/03/2006 and displayed until 04/09/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Updated on 16/07/2003 and displayed until 21/03/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Folic Acid
   Ascorbic Acid (Vitamin C)
   Riboflavine (Vitamin B2)
   Nicotinamide
   Thiamine Hydrochloride (Vitamin B1)
   Pyridoxine Hydrochloride (Vitamin B6)
   Vitamin E (tocopherol)
   Biotin
   Calcium pantothenate
   Inositol
   Acetomenaphthone

Versions

 
19/04/2011 to Current
04/09/2009 to 19/04/2011
21/03/2006 to 04/09/2009
16/07/2003 to 21/03/2006
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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