Has the mandatory text been included under this subheading? Yes No suspected adverse reactions after registration of the ‘Reporting medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at .’ 4.9 Correct heading used = 4.9 OVERDOSE Yes No Text relocated unchanged from section? Yes No ‘Overdosage’ Has the mandatory text been included? Yes No information on the management of overdose, contact the ‘For Poison Information Centre on 131126 (Australia).’ 5 Correct heading used = 5 PHARMACOLOGICAL Yes No PROPERTIES 5.1 Correct heading used = 5.1 PHARMACODYNAMIC Yes No PROPERTIES Relevant text relocated unchanged from and Yes No ‘Pharmacology’ trials’ sections? ‘Clinical Required subheadings included: Yes No Mechanism of action Clinical trials Yes No 5.2 Correct heading used = 5.2 PHARMACOKINETIC Yes No PROPERTIES Relevant text relocated unchanged from Yes No ‘Pharmacology’ section? Have the following subheadings been included where relevant? Absorption* Yes No Distribution* Yes No Yes No Metabolism* Excretion* Yes No 5.3 Correct heading used = 5.3 PRECLINICAL SAFETY DATA Yes No Relevant text relocated unchanged from section? Yes No ‘Precautions’ Note: if the carcinogenicity statement includes relevant clinical information it should be retained in Section 4.4, with a included under the Carcinogenicity subheading in section 5.3. Have the mandatory subheadings been included? Genotoxicity Yes No Carcinogenicity Yes No
Has the mandatory text been included under this subheading? ‘Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at .’ Yes No 4.9 Correct heading used = 4.9 OVERDOSE Yes No Text relocated unchanged from ‘Overdosage’ section? Yes No Has the mandatory text been included? ‘For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).’ Yes No 5 Correct heading used = 5 PHARMACOLOGICAL PROPERTIES Yes No 5.1 Correct heading used = 5.1 PHARMACODYNAMIC PROPERTIES Yes No Relevant text relocated unchanged from ‘Pharmacology’ and ‘Clinical trials’ sections? Yes No Required subheadings included: Mechanism of action Clinical trials Yes No Yes No 5.2 Correct heading used = 5.2 PHARMACOKINETIC PROPERTIES Yes No Relevant text relocated unchanged from ‘Pharmacology’ section? Yes No Have the following subheadings been included where relevant? Absorption* Distribution* Metabolism* Excretion* Yes No Yes No Yes No Yes No 5.3 Correct heading used = 5.3 PRECLINICAL SAFETY DATA Yes No Relevant text relocated unchanged from ‘Precautions’ section? Note: if the carcinogenicity statement includes relevant clinical information it should be retained in Section 4.4, with a included under the Carcinogenicity subheading in section 5.3. Yes No Have the mandatory subheadings been included? Genotoxicity Carcinogenicity Yes No Yes No
new-product-information-format-checklist-for-sponsors.docx