FY 2021 (No.382-)
| Japanese version issued on |
No. |
Table of contents |
PDF |
March 8,
2022 |
390 |
- Revision of Precautions for Aminolevulinic Acid Hydrochloride
- Revision of Precautions (No. 330)
Aminolevulinic acid hydrochloride (and 1 other)
- List of Products Subject to Early Post-marketing Phase Vigilance
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Full text [182 KB] |
January 18,
2022 |
389 |
- How to Start and Proceed with Improving Polypharmacy among the Elderly in Hospitals
- Important Safety Information
- Fingolimod hydrochloride
- Revision of Precautions (No. 329)
Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection) (and 11 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
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Full text [312 KB] |
December 14,
2021 |
388 |
- Suspected Adverse Reactions to Influenza Vaccines in the 2020 Season
- Important Safety Information
- Atezolizumab (genetical recombination)
- Revision of Precautions (No. 328)
Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection) (and 2 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [269 KB] |
November 9,
2021 |
387 |
- Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation with the System
- Acute coronary syndrome accompanying allergic reaction (Kounis Syndrome)
- Important Safety Information
- Cefoperazone sodium/sulbactam sodium
- Revision of Precautions (No. 327)
Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection) (and 5 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
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Full text [477 KB] |
October 5,
2021 |
386 |
- Precautions for Shock, Anaphylaxis in Patients Who Received Joyclu 30mg intra-articular injection to Improve Joint Function
- Revision of Precautions (No. 326)
COVID-19 (SARS-CoV-2) vaccine (recombinant chimpanzee adenovirus vector) (and 2 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [245 KB] |
August 20,
2021 |
385 |
- Revision of Proper Control Procedures for Revlimid/Pomalyst (RevMate)
- Important Safety Information
- [1] Magnesium sulfate hydrate/glucose [2] Magnesium sulfate hydrate
- Revision of Precautions (No. 325)
Nivolumab (genetical recombination) (and 9 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
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Full text [476 KB] |
| July 13, 2021 |
384 |
- Blood Monitoring and Rechallenge with Clozapine
- Important Safety Information
- Pembrolizumab (genetical recombination)
- Ixekizumab (genetical recombination)
- Revision of Precautions (No. 324)
Diclofenac etalhyaluronate sodium (and 3 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [343 KB] |
| June 10, 2021 |
383 |
- MID-NET (Medical Information Database NETwork)
- Revision of Precautions (No. 323)
Shosaikotokakikyosekko
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [649 KB] |
| April 27, 2021 |
382 |
- PI (Package insert)-navi: A Smartphone App Designed for Digitized Package Inserts
- Digitization of Reports from Medical Institutions on Adverse Drug Reactions and Post-vaccination Suspected Adverse Reactions
- Important Safety Information
- Ritodrine hydrochloride (injections)
- Durvalumab (genetical recombination)
- Onasemnogene abeparvovec
- Revision of Precautions (No. 322)
Magnesium sulfate hydrate/glucose (preparations indicated for prophylaxis and treatment of eclampsia in severe hypertensive disorders of pregnancy)
(and 8 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
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Full text [1.9 MB] |
