Drug database
Publishing of a new version of Table X – Standard terms for pharmaceutical dosage forms, routes and methods of administration and containers (2024)
The State Institute for Drug Control (SÚKL) informs marketing authorisation holders about the publication of the updated Table X – Standard terms for pharmaceutical dosage forms, routes and methods of administration and containers which includes newly added or modified terms and is effective from 1 September 2024.
Effective from 1 September 2024, in Table X, in addition to the introduction of newly added or modified terms approved by the EDQM, terms are also replaced, see the table below:
| Code | English term (GB) | Czech term (CZ) | Abbreviation |
|---|---|---|---|
| PDF-13177000 | Granules for gastro-resistant oral suspension1 | Granule pro enterosolventní perorální suspenzi | POR GSU ENT |
| PDF-13179000 | Granules for modified-release oral suspension2 | Granule pro perorální suspenzi s řízeným uvolňováním | POR GSU MRL (previously POR GSU RET) |
| PDF-1318000 | Granules for prolonged-release oral suspension3 | Granule pro perorální suspenzi s prodlouženým uvolňováním | POR GSU PRO |
| PDF-13178000 | Powder for gastro-resistant oral suspension4 | Prášek pro enterosolventní perorální suspenzi | POR PSU ENT |
| CMT-13182000 | Granules for gastro-resistant oral suspension in sachet5 | Granule pro enterosolventní perorální suspenzi v sáčku | POR GSU ENT SCC |
| CMT-13183000 | Granules for prolonged-release oral suspension in sachet6 | Granule pro perorální suspenzi s prodlouženým uvolňováním v sáčku | POR GSU PRO SCC |
| CDF-13181000 | Powder and solvent for gastro-resistant oral suspension7 | Prášek a rozpouštědlo pro enterosolventní perorální suspenzi | POR PNQ SUS |
| CDF-13170000 | Dispersion, powder and solvent for concentrate for dispersion for infusion8 | Disperze, prášek a rozpouštědlo koncentrátu pro infuzní disperzi | INF DSP LQC DIS |
1 Replaces the term „Gastro-resistant granules for oral suspension”; „Enterosolventní granule pro perorální suspenzi”.
2 Replaces the term „Modified-release granules for oral suspension”; „Granule s řízeným uvolňováním pro perorální suspenzi”.
3 Replaces the term „Prolonged-release granules for oral suspension”; „Granule s prodlouženým uvolňováním pro perorální suspenzi”.
4 Replaces the term „Gastro-resistant powder for oral suspension”; „Enterosolventní prášek pro perorální suspenzi”.
5 Replaces the term „Gastro-resistant granules for oral suspension in sachet”; „Enterosolventní granule pro perorální suspenzi v sáčku”.
6 Replaces the term „Prolonged-release granules for oral suspension in sachet”; „Granule s prodlouženým uvolňováním pro perorální suspenzi v sáčku”.
7 Replaces the term „Gastro-resistant powder and solvent for oral suspension”; „Enterosolventní prášek a rozpouštědlo pro perorální suspenzi”.
8 Replaces the term „Powder, dispersion and solvent for concentrate for dispersion for infusion”; „Prášek, disperze a rozpouštědlo koncentrátu pro infuzní disperzi”.
In order to speed up and unify the corrections of abbreviations of pharmaceutical dosage forms for the affected medicinal products, all modified abbreviations of pharmaceutical dosage forms will always be updated in the SÚKL´s medicinal products database on the effective date of the new version of Table X (i.e. on 1 September of the given year). This ensures that only a new abbreviation of the pharmaceutical dosage form corresponding to the description is generated for issued decisions/ resolutions/ notifications/ID sheets.
Medicinal products affected by the changes are listed in the following table:
- Seznam-LP-zmeny-v-DLP (xlsx, 10 kB)
Marketing Authorisation Section
14. 8. 2024