SmPC - Montelukast 4mg chewable Tablets: Change history
View Summary of Product Characteristics (SmPC - Montelukast 4mg 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: 21 Sep 2022)
Initial upload