PIL - Montelukast 5mg Chewable Tablets: Change history
View Patient Information Leaflet (PIL - Montelukast 5mg Chewable Tablets)
Last updated on this site: 26 Sep 2024
To update SmPC sections 4.4, 4.8 and PIL section 2 in line with information of reference product (Singulair 10 mg film-coated tablets; DCP procedure number: FI/H/0104/001; MAH: N.V. ORGANON) for Montelukast 4 mg & 5 mg Chewable Tablets.
Additionally, applicant has updated SmPC and PIL with editorial changes and PIL with the full form of European Economic Area and United Kingdom (Northern Ireland) as QRD template related changes in line with reference products.
Last updated on this site: 26 Sep 2024
To update SmPC sections 4.4, 4.8 and PIL section 2 in line with information of reference product (Singulair 10 mg film-coated tablets; DCP procedure number: FI/H/0104/001; MAH: N.V. ORGANON) for Montelukast 4 mg & 5 mg Chewable Tablets.
Additionally, applicant has updated SmPC and PIL with editorial changes and PIL with the full form of European Economic Area and United Kingdom (Northern Ireland) as QRD template related changes in line with reference products.
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Changes: (Updated: 26 Sep 2024)
To update SmPC sections 4.4, 4.8 and PIL section 2 in line with information of reference product (Singulair 10 mg film-coated tablets; DCP procedure number: FI/H/0104/001; MAH: N.V. ORGANON) for Montelukast 4 mg & 5 mg Chewable Tablets.
Additionally, applicant has updated SmPC and PIL with editorial changes and PIL with the full form of European Economic Area and United Kingdom (Northern Ireland) as QRD template related changes in line with reference products.
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Changes: (Updated: 14 Aug 2023)
Website administration update only- no changes to file.
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Changes: (Updated: 21 Sep 2022)
Initial upload