Nasacort Nasal Spray - Summary of Product Characteristics (SPC) - History

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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK Telephone: +44 (0)1483 505 515 Fax: +44 (0)1483 535 432 Medical Information e-mail: uk-medicalinformation@sanofi-aventis.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: 27/10/2011

SPC	Nasacort Nasal Spray

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 27/10/2011 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
Date of revision of text on the SPC: 13-Oct-2011
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
To update sections 4.4 and 4.8 with the risk of psychiatric adverse drug reactions to inhaled and intranasal corticosteriods and risk of non-psychiatric systemic adverse drug reactions to intranasal corticosteroids with consequential changes to the PIL

Updated on 01/08/2010 and displayed until 27/10/2011

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: 07-May-2010
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Updated sections 4.4 and 4.8 of SPC. Section 4.4: formatting changes, also wording of retardation in growth... changed to the following; Reduction in growth velocity. And following text has been added: . The long-term effects of reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height are unknown. . Glaucoma and/or cataracts have been reported in patients receiving nasal corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma and/or cataracts. Section 4.8 has been re-worded and re-formatted for clarity. Section 10: revision of text date changed to 7th may 2010.

Updated on 05/01/2009 and displayed until 01/08/2010

Reasons for adding or updating:
Correction of spelling/typing errors
Date of revision of text on the SPC: 01-Mar-2007
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
None provided

Updated on 18/09/2007 and displayed until 05/01/2009

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 6. 6 - Instructions for use, handling and disposal Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC: 03/2007
Legal Category: POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company
Section 2 (Qualitative and Quantitative composition): Main excipients listed here as well as in section 6.1 now. Section 4.2 (Posology and method of administration): Instructions on handling spray included here (previously in section 6.6) Section 6.6 (Special precautions for disposal): Instructions on handling the Nasacort spray removed from here (now in section 4.2) Section 7 (Marketing Authorisation Holder): Change in MA Holder's details