Regaine for Women Regular Strength - Summary of Product Characteristics (SPC) - History

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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 Women Regular 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: GSL
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: GSL
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 13/03/2009 and displayed until 13/10/2010

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: 27-Feb-2009
Legal Category: GSL
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Nature of change: Renewal of product licence. No changes to artwork as a result of this renewal. The SPC has been updated to reflect this renewal date and date of revision.

Updated on 19/05/2008 and displayed until 13/03/2009

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: GSL
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
None provided