New information on the website due to new variation regulation

Below you find new information concerning the product information, but for other updates, see the webpage "Variations" (Related information).

The product information in the context of variations

• Approval letter and updated Swedish product information (SmPC, PIL or labelling) will be sent to the applicant (MAH or the local representative) for all types of changes that affect the product information.
• If the applicant feel it necessary to implement 1A and 1AIN variations in the product information before the MPA has sent out approval letters, applicants can enter a new date of approval in the product information. If so, the text in the package leaflet is changed as follows:  "This leaflet was last approved ..." to "This leaflet was last updated ...". Section 10 of the SmPC is however left unchanged.
• When the updated product information is then sent from the MPA, it will have a new approval date. MAH should then at the next printing update their package leaflet with this date and also change back to the original wording: "This leaflet was last approved ..." in accordance with the approved version published on the MPA website. In all other cases, we ask the applicant to await the approval letter with updated product information prior to the amendment in question is implemented in the product information.
• When contacting the MPA regarding the product information please use the latest approved version of the current product information (published on the MPA website). All proposed changes should be presented using the Word feature "track changes". It should be clearly stated in the cover letter, what changes have already been implemented in the product information and the date it occurred. The cover letter should also indicate a reference to the variation procedure number, as appropriate, and a brief description of the variation.