Elmex Medical Cariësprotectiegel Qsodium Fluoride, Amine Fluoride; Olaflur and Dectaflur)

Case: 306194 RVG: 06269

Elmex Medical Cariësprotectiegel QSodium fluoride, Amine Fluoride; Olaflur and dectaflur)

Abbreviated PSUR ASSESSMENT REPORT

13 September 2013

Pharmaceutical form(s) Dental gel 12,5 mg/g MAH(s) Gaba B.V. IBD/EU BD 17 June 1962 (Switzerland)/03 Julyl 969 (Belgium) PSUR Ol August 2009 - 31 July 2012 Assessor Contact point PSUR assessment checklist Action needed / required Yes No 1. The MAH'S perspective: action proposed? ^ • 2. Does the CCDS contain more information than the SPC? ^ • 3. Outstanding issues previous PSUR assessment? • 4. The MEB's perspective: additional action required? •

Quality of provided documentation: 5. Does this PSUR meet Volume 9A requirements? ^ O 6. Does section 4.8 of the SPC meet the current SPC guidelines requirements? CH K

Summary of PSUR assessment The MAH submitted a PSUR for Elmex Gel containing Amine Fluoride; Olaflur and dectaflur covenn^hêno^^ÂuguiÔO^-^^^ 2012, dated September 2012, by cover letter). Elmex fluoride toothpaste containm^^^^n^MnmÎuondes (30.32 mg olaflur and 2.87 mg dectaflur) and 22.1 mg sodium fluoride per gram of gel. This corresponds to a total fluoride content of 1.25 %.

Elmex gel is used topically in caries prophylaxis for the fluoridation of tooth enamel. The dental fluid promotes remineralisation of initial caries and is suitable for the treatment of hypersensitive dental necks. In addition, the amine fluorides olaflur/dectaflur have antimicrobial properties.

Assessor's comment: A benefit/risk evaluation was lacking with the submission. According to this new pharmacovigilance legislation the MAH should submit a critical benefit-risk evaluation This benefit/risk evaluation should now be submitted with the response. Further guidance on how this evaluation should be presented can be found in the Guideline on Good Pharmacovigilance Practices (GVP) - Module VII (Periodic safety update report).

Actions taken for safety reasons None

Changes to reference safety information The CCSI was amended during the review period and the latest version of the CCSI, version 7 is dated 2 February 2009. The MAH states they will revise the SmPC according to the changes made to the CCSI.

Assessor's comment: The current CCSI includes more relevant safety information in sections 4.3, 4.4, 4.8 and 4.9 than the current SmPC.

2 The MAH should submit a type II variation to update their SmpC with the missing safety information from the CCSI Supporting data for inclusion of this information should also be provided. With this variation section 4.8 Undesirable effects should be brought in line with the current SmPC guideline dated September 2009. Patient exposure The MAH presents patient exposure by packs sold. During the review period immVpacks of Elmex were sold. Adverse events Overall, 59 medically confirmed case reports were received during the review period encompassing 5 serious reports. Two were related to an accidental ingestion of the product by children, one was an allergic shock and the two others were mouth inflammation considered as serious by the reporters.

Assessor's comment: It is clearly stated in the current SPC that the product should not be ingested. The SmPC should be updated with undesirable effects of the CCSI including but not limited to inflammation.

Comments to be forwarded to the MAH The assessment of the PSUR of Elmex Gel covering the period Ol August 2009 - 31 July 2012, led to the following conclusions:

Regarding the SPC The current CCSI includes more relevant safety information in sections 4.3, 4.4, 4.8 and 4.9 than the current SmPC. The MAH should submit a type II variation to update ti^eir SmpC with the missing safety information from the CCSI.Supporting data for inclusion of this information should also be provided. With this variation section 4.8 Undesirable effects should be brought in line with the current SmPC guideline dated September 2009.

Regarding the PSUR A benefit/risk evaluation was lacking with the submission. According to this new pharmacovigilance legislation the MAH should submit a critical benefit-risk evaluation This benefit/risk evaluation should now be submitted with the response. Further guidance on how this evaluation should be presented can be found in the Guideline on Good Pharmacovigilance Practices (GVP) - Module VII (Periodic safety update report).

Next PSUR The MAH should take into account the following:

3 For medicinal products authorized under the legal basis of Article 10(1) or Article IOa of Directive 2001/83/EC, no routine PSURs need to be submitted, unless otherwise specified on the EURD list.