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Post-marketing Safety Measures

Safety Information Announced by MHLW

Date Title
June 20, 2013 Revision of the Precautions section of the package inserts of Recombinant Adsorbed Bivalent Human Papillomavirus-like Particle Vaccine (derived from Trichoplusia ni cells) and Recombinant Adsorbed Quadrivalent Human Papillomavirus Virus-Like Particle Vaccine (Yeast Origin) [116 KB]

Related information:
Main information on the safety review meeting on Cervarix and GARDASIL [146 KB]
February 14, 2012 PFSB/SD Notification 0214-9 "Call attention to the Precautions of anti-influenza virus drugs" [164 KB]
June. 23, 2011 Safety Measures for diabetes medication "pioglitazone-containing products [68.4 KB]

Annex [61.7 KB]
March. 29, 2011 < Q and A> [86.4 KB]
Resuming vaccination with the pediatric pneumococcal conjugate vaccine and the Hib vaccine (Issued by the Tuberculosis and Infectious Disease Control Division, Health Service Bureau and Safety Division, Pharmaceutical and Food safety Bureau)

For Japanese: http://www.mhlw.go.jp/stf/houdou/2r98520000016yw1.html

[Reference] [110 KB]
Safety review results pneumococcal conjugate vaccine and Haemophilus influenza type b (Hib) vaccine foe pediatrics (Issued as on March 24th by the Joint meeting of subcommittee on Drug Safety and Vaccine Adverse Reaction Review Committee for Carcinoma of the Uterine Cervix)

For Japanese: http://www.mhlw.go.jp/stf/houdou/2r985200000167mx.html

(List of Fatal Case Reports) [155 KB]