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Boehringer Ingelheim Limited
Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Telephone: +44 (0)1344 424 600
Fax: +44 (0)1344 741 298
WWW: http://www.boehringer-ingelheim.co.uk
Medical Information Direct Line: +44 (0)1344 741 286
Medical Information e-mail: medinfo@bra.boehringer-ingelheim.com

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Summary of Product Characteristics last updated on the eMC: 12/07/2011
SPC MIRAPEXIN 0.52 mg prolonged-release 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 12/07/2011 and displayed until Current
Reasons for adding or updating:
  • 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:   17-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 has been updated to include information relating to cardiac failure and amendments have been made in relation to the frequency information for some side effects

Section 10:
Date of revision of the text has also been updated.
Updated on 21/01/2011 and displayed until 12/07/2011
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • 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:   20-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.3:
Section 5.3 of the SPC has been updated to include information concerning delayed sexual development observed in rats. The following statement has been added:

'A delay in sexual development (i.e., preputial separation and vaginal opening) was observed in rats. The relevance for humans is unknown.'

Section 7:
Please also note that a minor change has been made to the MA holder address i.e.
'Binger Straße 173' has been revised to 'Binger Strasse 173' to align with the commission annexes.

Section 10:
Date of revision of the text has also been updated.
Updated on 20/12/2010 and displayed until 21/01/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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 10 date of revision of the text
Date of revision of text on the SPC:   25-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2
Inclusion of specific information on missed dose. Plus minor correction.

Section 4.5
update to include the results of an in depth evaluation of hOCT2 inhibitors

Section 4.6
revision of information on fertility

Section 4.8
update of information based on PSUR 13 to include new side effects and revise frequency categories

Date of revision amended.
Updated on 19/07/2010 and displayed until 20/12/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 & 5.1
Information added regarding use in Paediatric population.

Section 10
Date of revision of text updated.
Updated on 05/07/2010 and displayed until 19/07/2010
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


- Minor editorial changes to sections 4.1, 4.2, and 5.1

- Addition of paragraph to section 4.8 to align with the standard release tablets

- Reformatting of section 4.6 in line with current guidance

- Update of revision date to 17 June 2010 – section 10

Updated on 21/10/2009 and displayed until 05/07/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  pramipexole dihydrochloride monohydrate