Ongoing Drug Safety Evaluations, Risk Information

日本語ページはこちら This webpage provides drug risk information which has come under review by the PMDA and the Ministry of Health, Labour and Welfare (MHLW). Information provided here is as follows:

1. Risk information suggested by a certain amount of accumulated information of adverse drug reactions (ADR) reports or Early Post-marketing Phase Vigilance (EPPV) Safety measures such as revision of PRECAUTIONS in the package insert of the product might be taken after the ongoing review. When evaluations are completed, the information in the table below will be deleted. You will find the results of evaluation on the “ Revisions of PRECAUTIONS ” webpage.
2. Risk information which has attracted the attention of foreign regulatory agencies or academic societies based on studies published in scientific journals, etc., for which the PMDA and MHLW have started their evaluation since the risk information is related to drugs marketed in Japan Information provided here is still under review. If you are taking the following drugs, you should NOT stop taking them or reduce the dosage without consulting a physician. Consult your healthcare professionals if you have any questions or concerns about these drugs.

Recombinant adsorbed quadrivalent human papillomavirus virus-like particle vaccine | Symptoms related to pain | － | Summary of
the Report on the
Surveillance
Results of
HPV Vaccines [40.4 KB] |

Avastin
(bevacizumab) for
breast cancer
indication [54.3 KB] | Press
Announcement
from the FDA

Review report of
AVASTIN 100mg/4mL
Intravenous Infusion
and AVASTIN 400mg/
16mL Intravenous
Infusion on
July 14, 2011
(only in Japanese)
[1,708 KB] | － |

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Recombinant adsorbed quadrivalent human papillomavirus virus-like particle vaccine | Symptoms related to pain | － | Summary of
the Report on the
Surveillance
Results of
HPV Vaccines[40.4 KB] |