Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

Alliance Pharmaceuticals
Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB
Telephone: +44 (0)1249 466 966
Fax: +44 (0)1249 466 977
WWW: http://www.alliancepharma.co.uk
Medical Information e-mail: medinfo@alliancepharma.co.uk

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: 19/04/2012
SPC Isotretinoin 5mg capsules

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 19/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change of Marketing Authorisation Holder
Date of revision of text on the SPC:   04-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changes highlighted in red text below


7.         MARKETING AUTHORISATION HOLDER

 

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

UK

 

 

8.         MARKETING AUTHORISATION NUMBER

 

PL  16853/0132
Updated on 15/08/2011 and displayed until 19/04/2012
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   24-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Date of revision 24 September 2010
Updated on 28/05/2009 and displayed until 15/08/2011
Reasons for adding or updating:
  • Introduction of new pack/pack size
Date of revision of text on the SPC:   21-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Introduction of a 30 capsule pack
Updated on 27/10/2008 and displayed until 28/05/2009
Reasons for adding or updating:
  • 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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   13-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Skin and subcutaneous tissues disorders - cross-reference to section 4.5 added.
Section 4.5 - avoidance of concurrent administration with topical keratolytic or exfoliative anti-acne agents advised. Cross-reference to section 4.4. Additional text
Section 4.7 - additional warnings added in second paragrpah.
Section 4.8 - additional undesirable effects in Psychiatric disorders, Nervous system disorders and Eye disorders
Section 10 - date of revision of text updated to 13 October 2008
Updated on 06/12/2006 and displayed until 27/10/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 (Contraindication) - patients with peanut allergy may suffer cross reactivity to soya protein added
Updated on 28/11/2006 and displayed until 06/12/2006
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 (Contraindications) - patients with peanut allergy may suffer cross reactivity to soya protein added
Updated on 08/11/2006 and displayed until 28/11/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   02/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - (Special warnings and precautions for use) under Psychiatric disorders - added 'suicidal ideation, suicide attempts'
 
Section 4.8 - (Undesirable effects) under Psychiatric disorders - Very Rare - added 'suicidal ideation, suicide attempt'
Updated on 13/06/2005 and displayed until 08/11/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • SPC Retired pending re-submission
Updated on 10/01/2005 and displayed until 13/06/2005
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  isotretinoin