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McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
Medical Information Direct Line: 01344 864042
Medical Information e-mail: medinfo@its.jnj.com

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: 16/04/2012
SPC Regaine for Men Extra Strength

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 16/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   26-Mar-2012
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update to sections 4.4 (Special warnings and precautions for use) and 4.8 (Undesirable effects) of SmPC

 
Updated on 13/10/2010 and displayed until 16/04/2012
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06-Oct-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Reasons for change: Changes to sections 2, 4.4, 4.5 for RGC01 (Regaine for Men Extra Strength Solution), 4.6, 4.8, 4.9, 5.1-5.3, 6.2 and 6.6 of the SPC to align with the Company Core Data Sheet.
Updated on 21/07/2009 and displayed until 13/10/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Jul-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The shelf life of Regaine Extra Strength for Men has been changed form 24 Months to 36 Months
Updated on 19/05/2008 and displayed until 21/07/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   11-Apr-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 20/09/2006 and displayed until 19/05/2008
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   08/2005
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 10 Change to date of revision of text
Updated on 26/08/2005 and displayed until 20/09/2006
Reasons for adding or updating:
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 24/08/2005 and displayed until 26/08/2005
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
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