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Cephalon (UK) Limited
1 Albany Place, Hyde Way, Welwyn Garden City, Hertfordshire, AL7 3BT
Telephone: +44 (0) 1707 385800
Fax: +44 (0) 1707 385801
WWW: http://www.cephalon.co.uk
Medical Information Direct Line: 0800 783 4869
Medical Information e-mail: ukmedinfo@cephalon.com
Medical Information Fax: +44 (0) 1707 385802

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: 17/05/2011
SPC Zelapar

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 17/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   07-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 has been updated to add the following wording:

Doping screening tests 
The use of selegiline may produce a positive result in doping screening tests.
Updated on 08/07/2010 and displayed until 17/05/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   20-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


For information it is sections 2, 4.2, 4.3, 4.7, 4.8, 5.1 and 7 of the SmPC that have been updated.

Sections 2, 4.2, 4.3, 4.7, and 5.1 have been updated in order to align the SmPC text with the current European guidelines (QRD template)

Section 4.8 of the SmPC has been amended to correct an SOC term in line with the MedDRA terminology

Section 7 of the UK SmPC is also amended to correct the MAH address.

Updated on 11/06/2010 and displayed until 08/07/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • 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-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Sections 7, 8, 9 and 10 of the SmPC have been updated as follows:

Section 7:  Marketing Authorisation Holder has been changed to Cephalon UK Limited, 1 Albany Place, Hyde Way, Welwyn Garden City, Hertfordshire

Section 8: Marketing Authorisation Number(s) has been changed from PL 21799/0017 to PL 16260/0031.

Section 9: Date of First Authorisation/Renewal of the Authorisation

Section 10:  Date of Revision of Text

Updated on 30/04/2009 and displayed until 11/06/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable Effects
  • 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:   18-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2 QUALITATIVE AND QUANTITATIVE COMPOSITION – add the following wording: Each tablet contains 1.25mg of aspartame (source of Phenylalanine)

Section 4.8 UNDESIRABLE EFFECTS – Complete re-write. The Adverse events have been converted to a table using MEDDRA headings and frequencies. The wording has also been clarified regarding AEs seen with Zelapar or conventional selegiline.

 

Section 9 (DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION) has been changed from 30 January 2006 to 18/09/2008

Section 10 (DATE OF REVISION OF THE TEXT) has been changed from 22.11.2006 to 18/09/2008

 
Updated on 05/02/2008 and displayed until 30/04/2009
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   01/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The marketing authorisation holder's contact details has changed from The Magdalen Centre, Oxford Science Park, Oxford, OX4 4GA, UK to 1 Albany Place, Hyde Way, Welwyn Garden City, Hertfordshire, AL7 3BT, UK for both the UK and for Portugal only.
Updated on 19/06/2007 and displayed until 05/02/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
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 7 - Marketing Authorisation Holder

 

changed to:

 

Cephalon Limited

The Magdalen Centre

Oxford Science Park

Oxford

Oxfordshire

OX4 4GA

United Kingdom
Updated on 13/03/2006 and displayed until 19/06/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 27/09/2005 and displayed until 13/03/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 28/05/2004 and displayed until 27/09/2005
Reasons for adding or updating:
  • Company name change or merger
Updated on 19/07/2001 and displayed until 28/05/2004
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 11/07/2000 and displayed until 19/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 18/01/2000 and displayed until 11/07/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 18/01/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  selegiline hydrochloride