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PIL- Betamethasone Valerate 0.1% w/w Cream: Change history

  • IAin, E.4.b - to update address of the registered Finished product manufacturer, Batch release site, QC testing site and Primary & Secondary packaging site Tiofarma B.V. from Benjamin Franklinstraat 5-10, 3261 LW Oud-Beijerland, The Netherlands to Hermanus Boerhaavestraat 1, 3261 ME Oud-Beijerland, The Netherlands. Product Information Leaflet is updated accordingly.

    • Changes: (Updated: 24 Apr 2026)

      IAin, E.4.b - to update address of the registered Finished product manufacturer, Batch release site, QC testing site and Primary & Secondary packaging site Tiofarma B.V. from Benjamin Franklinstraat 5-10, 3261 LW Oud-Beijerland, The Netherlands to Hermanus Boerhaavestraat 1, 3261 ME Oud-Beijerland, The Netherlands. Product Information Leaflet is updated accordingly.

    • Changes: (Updated: 14 Nov 2023)

      Description of update: To register the addition of INN name Betamethasone Valerate 0.1% w/w Cream to the MA. Consequentially, SmPC sections 1, 4.2, 4.3, 4.4, 4.7, 4.9 and 10 have been updated and new artwork created for Betamethasone Valerate PIL/Cartons/Tube Labels.

      PIL sections updated: 1, 2, 3, 4, 5 and 6.

    • Changes: (Updated: 14 Nov 2023)

      Description of update: To register the addition of INN name Betamethasone Valerate 0.1% w/w Cream to the MA. Consequentially, SmPC sections 1, 4.2, 4.3, 4.4, 4.7, 4.9 and 10 have been updated and new artwork created for Betamethasone Valerate PIL/Cartons/Tube Labels.

      PIL sections updated: 1, 2, 3, 4, 5 and 6.

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