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2009年10月23日(金)

OTC??????????????????????(??)

投稿者: ????????

??????????????TGA?22??OTC??????????????????6????????????12???????????????????????????????????????12?18??????????????????????????

Labelling and packaging of cough and cold medicines - proposed changes to requirements?TGA 2009.10.22?
http://www.tga.health.gov.au/npmeds/consult/drlp-ccmedicines.htm

?TGA???????????????????????????????????6?????????????????????????6???12??????????????????????????????????????????????

  • OTC??????????6???????????????????6???12????????????????????????????????????
  • 2010?7?1????????????????????????
  • ?????????????????S2 (pharmacy only??????)???6??11???????????S3 (pharmacist only ?????)?6?????????S4????????????????
  • 6???????????OTC?????????????????????????????????????????????????????????????????????

????????????????

??? ??????????????????????????pholcodine?pentoxyverine
??? ??????????????????????????????ipecacuanha???????????
???????? ???????????????????oxymetazoline?xylometazoline
??????? ??????????????????????????????????brompheniramine?doxylamine?triprolidine?dexchlorpheniramine

????????????????????(PDF????)

Summary of actions taken by the TGA and other regulatory agencies regarding cough and cold medicines in the treatment of children
?????????????????????????????????????

Review of cough and cold medicines in children
???????????????????

Tabulated summaries of clinical trials prepared by the TGA to accompany the Report by the External Reviewers
????????????????????

TGA internal panel report on the safety, efficacy and use of cough and cold medicines in the treatment of children aged 2-12 years
????????????????????????

TGA Internal Panel to review cough and cold medicines for children aged 2-12 years
??6?25??????????????????

Extract of Minutes Medicines Evaluation Committee Meeting
??7?30?????????????????????

?TOPICS 2009.5.12 ?????????????????????????????????????????????????????????????????????????????????????????????????

????????????????????????????????????????????????????????????????????????????????TOPICS 2009.08.08???OTC???????????????????????OTC???????????????????????????????????????????????????????????????????????

?????????????????????????????????????????????OTC????????????????????????????????

?????TOPICS
?2009.05.12?OTC?????????????????????????
?2008.07.05?2????OTC???????????
?2008.04.09?????????2???????????(??)
?2009.10.08?6????????????????????????(NZ)
?2009.03.01??????6?????OTC?????????????????
?2008.12.19???????6?????OTC?????????????????
?2008.10.08????OTC????4????????????????
?2008.01.18???????????2???????????????
?2008.12.21?OTC????????????????????????????
?2008.01.30??????????????????????????(??)
?2006.01.11?OTC?????????????????

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