10. Platelet values should be This has been addressed in the This is considered reported in the unit x109/L revised PI. acceptable in the which is more commonly used context of this in Australia. application pending approval by the Delegate. 11. In the This has been addressed in the This is considered ‘Precautions’ section, the PI should contain revised PI. acceptable in the similar information on hepatic context of this decompensation, as found in application pending the SmPC. approval by the Delegate. 12. In the Events’ This has been addressed in the This is considered ‘Adverse Section, the PI should align revised PI. acceptable in the with the proposed EU SmPC context of this that contains many additional application pending adverse events not proposed approval by the to be included in the Delegate. Australian PI. This applies to all indications. Uncommon events may be grouped separately. 13. In the The sponsor confirms that the This is considered ‘Overdosage’ section, the PI should include current Revolade CMI contains acceptable in the the poison information the Poisons Information context of this telephone number. Centre contact number, and application pending that the proposed PI has been approval by the revised to also include this Delegate. data in the OVERDOSAGE section. The revised, draft Product Information and Consumer Medicine Information are provided. In addition, please see the responses to 9, 10, 11, 12, 13 and 14. Furthermore, the sponsor provides an update on the international regulatory status of similar applications overseas and the currently approved Product Information in the USA, Canada, and Europe. 14. It is recommended to the The sponsor have revised the This is considered Delegate that the current CMI document to acceptable in the consumer medicines include Severe Aplastic context of this information document be Anemia (What Revolade is application pending revised to accommodate the used for), How much to take it, approval by the changes made to the product and possible side effects. The Delegate. information document. revised document is included with this response.
10. Platelet values should be reported in the unit x109/L which is more commonly used in Australia. This has been addressed in the revised PI. This is considered acceptable in the context of this application pending approval by the Delegate. 11. In the ‘Precautions’ section, the PI should contain similar information on hepatic decompensation, as found in the SmPC. This has been addressed in the revised PI. This is considered acceptable in the context of this application pending approval by the Delegate. 12. In the ‘Adverse Events’ Section, the PI should align with the proposed EU SmPC that contains many additional adverse events not proposed to be included in the Australian PI. This applies to all indications. Uncommon events may be grouped separately. This has been addressed in the revised PI. This is considered acceptable in the context of this application pending approval by the Delegate. 13. In the ‘Overdosage’ section, the PI should include the poison information telephone number. The sponsor confirms that the current Revolade CMI contains the Poisons Information Centre contact number, and that the proposed PI has been revised to also include this data in the OVERDOSAGE section. The revised, draft Product Information and Consumer Medicine Information are provided. In addition, please see the responses to 9, 10, 11, 12, 13 and 14. Furthermore, the sponsor provides an update on the international regulatory status of similar applications overseas and the currently approved Product Information in the USA, Canada, and Europe. This is considered acceptable in the context of this application pending approval by the Delegate. 14. It is recommended to the Delegate that the consumer medicines information document be revised to accommodate the changes made to the product information document. The sponsor have revised the current CMI document to include Severe Aplastic Anemia (What Revolade is used for), How much to take it, and possible side effects. The revised document is included with this response. This is considered acceptable in the context of this application pending approval by the Delegate.
auspar-eltrombopag-160330.docx