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Newport Pharmaceuticals Limited
Frans Maas House, Swords Business Park, Swords, Co. Dublin, , Ireland
Telephone: + 353 1 890 3011
Fax: + 353 1 890 3016

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 20/01/2011
SPC Imunovir

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 20/01/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   14-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
section 9 update to reflect renewal date
section 10 update to revision of text date
Updated on 14/07/2006 and displayed until 20/01/2011
Reasons for adding or updating:
  • Change from BAN to rINN
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • 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. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 1.0    NAME OF THE MEDICINAL PRODUCT  

Addition of strength and form to product name - addition shown in bold

 

IMUNOVIR 500 mg Tablets

 

 

SECTION 2. 0    QUALITATIVE AND QUANTITATIVE COMPOSITION

INN name of product inserted (addition shown in bold)  

 

Each tablet contains 500mg Inosine Acedoben Dimepranol (INN, also known as inosine pranobex*)

 

Section 4.0    PHARMACEUTICAL FORM

Tablet shape and marking changed (shown in bold)

 

Changed to

 

White to off-white tablets with a faint amine odour, engraved with a score-line on one side and 'DN' on the other.

The score-line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

 

 

SECTION 5.2    PHARMACOKINETIC PROPERTIES

INN name of product inserted (inosine pranobex replaced with inosine acedoben dimepranol

(Text change shown in bold)  

 

Following a single oral dose of inosine acedoben dimeparanol, peak plasma conditions of inosine occur after 1 hour. However, 2 hours after administration, plasma concentrations decrease to undetectable amounts. Inosine acedoben dimeparanol has a very short plasma half-life of 50 minutes following an oral dose.

 

SECTION 6.1    LIST OF EXCIPIENTS

Formulation change to excipients --   replacement of starch modified, stearic acid and microcrystalline cellulose (replacement shown in bold)

 

Povidone, Mannitol, Wheat Starch, Magnesium Stearate

         

SECTION 6.3    SHELF-LIFE

Changed from 36 months to 5 years
 
 
SECTION 6.4     SPECIAL PRECAUTIONS FOR STORAGE

Changed from Do not store above 25oC to

This medicinal product does not require any special storage conditions.
 
 
SECTION 6.5    NATURE AND CONTENTS OF CONTAINER

Pack Type changed from bottle to blister pack – New text shown in bold

 

100 (5 x 20) tablets in transparent, colourless PVC/PVDC blister packs sealed with aluminium foil.
 
 
SEction 9.0    DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION

Change shown in bold  

 

15th November 1983/ 1st October 2003

 

 

Section 10.0    DATE OF REVISION OF THE TEXT

Change shown in bold 

 

June 2006
Updated on 29/09/2005 and displayed until 14/07/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Correction of spelling/typing errors
Updated on 01/10/2004 and displayed until 29/09/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 01/10/2003 and displayed until 01/10/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 30/08/2001 and displayed until 01/10/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 30/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  inosine acedoben dimepranol