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
6 Correct heading used = 6 PHARMACEUTICAL PARTICULARS Yes No 6.1 Correct heading used = 6.1 LIST OF EXCIPIENTS Yes No If excipient list was retained in section 2, has the appropriate cross-reference been added? [not appropriate for new PIs]* ‘Refer to Section 2 - Qualitative and quantitative composition’ Yes No N/A 6.2 Correct heading used = 6.2 INCOMPATIBILITIES Yes No If there is no statement in approved PI, has the optional standard text been added? ‘Incompatibilities were either not assessed or not identified as part of the registration of this medicine’, or a relevant to section 4.5. Yes No N/A 6.3 Correct heading used = 6.3 LIFE Yes No If the shelf-life is not included, has the optional standard text been used? ‘In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.’ Yes No N/A 6.4 Correct heading used = 6.4 SPECIAL PRECAUTIONS FOR STORAGE Yes No 6.5 Correct heading used = 6.5 NATURE AND CONTENTS OF CONTAINER Yes No 6.6 Correct heading used = 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL Yes No If there is no statement in approved PI, has one of the optional standard text statements been added? ‘In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy’ or ‘In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements’ Yes No N/A 6.7 Correct heading used = 6.7PHYSICOCHEMICAL PROPERTIES Yes No Have the mandatory subheadings been included? Chemical structure CAS number Yes No Yes No 7 Correct heading used = 7 MEDICINE SCHEDULE (POISONS STANDARD) Yes No 8 Correct heading used = 8 SPONSOR Yes No