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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen.co.uk
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550

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: 12/10/2011
SPC Micronor Oral Contraceptive Tablets

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 12/10/2011 and displayed until Current
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   06-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.2, starting treatment, missed tablets and vomiting and diarrhoea has been updated.

In section 4.3, contraindicatioin have been removed, now only two contraindications

Section 4.4 , information moved to section 4,2 and breast cancer infomration has been moved from section 4.8, Warnings and precatuions have been updated.

Section 4.5- new interaction sadded.

Section 4.6, general update.

Sectiomn 4.8 only change breast cancer information moved to section 4.4.

Section 4.9, general update.
Updated on 19/02/2009 and displayed until 12/10/2011
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:   11-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 7 - New MAH address
Change to section 10 - Changed to 11 February 2009
Updated on 09/12/2008 and displayed until 19/02/2009
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:   04-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 9 – Date of Renewal of Authorisation

Addition of:

Renewal of Authorisation: 4 December 2008

 

Change to section 10 – Date of revision of the text

Changed to 4th December 2008
Updated on 22/08/2001 and displayed until 09/12/2008
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 16/10/2000 and displayed until 22/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 16/10/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  norethisterone