PIL - Argatroban 1 mg/ml solution for infusion: Change history
View Patient Information Leaflet (PIL - Argatroban 1 mg/ml solution for infusion)
Last updated on this site: 17 Nov 2025
The following changes have been notified:
A.5. b) The activities for which the manufacturer/importer is responsible do not include batch release
• A.5. b) Change in the name of "Eurofins Analytical Services Hungary Kft." to "Eurofins BioPharma Product Testing Budapest Kft." as batch control/testing site. The address "Anonymus u 6., Budapest, 1045, Hungary" remains unchanged.
• A.5. b) Change in the name of "Pharmavalid Ltd." to "Pharmavalid Kft." as batch control/testing site. The address "1136 Budapest, Tátra u. 27/b Hungary" remains unchanged.
A.7. Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier)*
• A.7. Deletion of "Accord Healthcare B.V. Utrecht, Winthontlaan 200 3526 KV at Utrecht, The Netherlands" as batch release site.
Last updated on this site: 17 Nov 2025
The following changes have been notified:
A.5. b) The activities for which the manufacturer/importer is responsible do not include batch release
• A.5. b) Change in the name of "Eurofins Analytical Services Hungary Kft." to "Eurofins BioPharma Product Testing Budapest Kft." as batch control/testing site. The address "Anonymus u 6., Budapest, 1045, Hungary" remains unchanged.
• A.5. b) Change in the name of "Pharmavalid Ltd." to "Pharmavalid Kft." as batch control/testing site. The address "1136 Budapest, Tátra u. 27/b Hungary" remains unchanged.
A.7. Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier)*
• A.7. Deletion of "Accord Healthcare B.V. Utrecht, Winthontlaan 200 3526 KV at Utrecht, The Netherlands" as batch release site.
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Changes: (Updated: 17 Nov 2025)
The following changes have been notified:
A.5. b) The activities for which the manufacturer/importer is responsible do not include batch release
• A.5. b) Change in the name of "Eurofins Analytical Services Hungary Kft." to "Eurofins BioPharma Product Testing Budapest Kft." as batch control/testing site. The address "Anonymus u 6., Budapest, 1045, Hungary" remains unchanged.
• A.5. b) Change in the name of "Pharmavalid Ltd." to "Pharmavalid Kft." as batch control/testing site. The address "1136 Budapest, Tátra u. 27/b Hungary" remains unchanged.
A.7. Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier)*
• A.7. Deletion of "Accord Healthcare B.V. Utrecht, Winthontlaan 200 3526 KV at Utrecht, The Netherlands" as batch release site.
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Changes: (Updated: 25 Mar 2024)
Description of update: Adaptation of the PI to reference product Novastan (SE/H/0483); furthermore editorial changes.
PIL sections updated: Introduction, Index, 2, 4 and 6.
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Changes: (Updated: 20 Sep 2022)
Initial upload