FY 2019 (No.362-)
| Japanese version issued on |
No. |
Table of contents |
PDF |
| March 24, 2020 |
371 |
- For the Promotion of Pediatric Clinical Development (development and safety measures) through Active Use of Medical Information Database
(Part 2) Assessment of Adverse Events with Use of the Pediatric Medical Data Collecting System and Efforts Focused on Future Utilization of the System
- Handling of Relative Contraindications associated with Revision of Instructions for Package Inserts of Prescription Drugs
- Important Safety Information
- Rotigotine
- Aminolevulinic acid hydrochloride
- Revision of Precautions (No. 311)
Rotigotine (and 8 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [578 KB] |
| February 18, 2020 |
370 |
- For the Promotion of Pediatric Clinical Development (development and safety measures) through Active Use of Medical Information Database (Part 1)
Maintaining the Pediatric Medical Data Collecting System and Examples of a Survey on the Drug Use in Children through Active Use of the System
- Post-Marketing Information Collection and Malfunctions Report from Medical Institutions for Medical Devices
- Important Safety Information
- Ipragliflozin L-Proline
- Olmesartan medoxomil
- Secukinumab (genetical recombination)
- Revision of Precautions (No. 310)
- Levodopa
- Levodopa/carbidopa hydrate
- Levodopa/benserazide hydrochloride (and 6 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [799 KB] |
| January 9, 2020 |
369 |
- Safety of Influenza Antiviral Drugs
- Suspected Adverse Reactions to Influenza vaccines in the 2018 Season
- Important Safety Information
- Atezolizumab (genetical recombination)
- Osimertinib mesilate
- Bilastine
- Revision of Precautions (No. 309)
Mecasermin (genetical recombination) (and 3 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [396 KB] |
| November 26, 2019 |
368 |
- Initiative of Revision of the Manuals for Management of Various Serious Adverse Drug Reactions (Part 3)
- Important Safety Information
- Vonoprazan fumarate
- Revision of Precautions (No. 308)
Vonoprazan fumarate (and 3 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [330 KB] |
| October 23, 2019 |
367 |
- Publication of Risk Management Plan (RMP) Materials on the PMDA website
- Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation with the System
- Important Safety Information
- Baricitinib
- Osimertinib mesilate
- Revision of Precautions (No. 307)
Baricitinib (and 14 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [827 KB] |
| September 17, 2019 |
366 |
- Introduction of the International Standards (ISO [IEC] 80369 series) Related to Connectors for Prevention of Interconnection
-Switching of small-bore connectors for enteral application
- Important Safety Information
- Freeze-dried BCG vaccine
- Revision of Precautions (No. 306)
Apomorphine hydrochloride hydrate (and 9 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [555 KB] |
| August 6, 2019 |
365 |
- Review of Contraindications of Metformin including “renal impairment”
- Safety Measures for Febuxostat
- Guidance of Appropriate Medication for Elderly Patients [particular (by recuperation environment)]
- Proper Use of Over-the-Counter (OTC) Drugs that May Lead to Abuse
- Important Safety Information
- Nivolumab (genetical recombination)
- Palbociclib
- Revision of Precautions (No. 305)
Epoprostenol sodium (and 10 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [781 KB] |
| July 2, 2019 |
364 |
- Interstitial lung disease by abemaciclib
- Review of “glaucoma” as a contraindication for anticholinergic drugs
- Important Safety Information
- Abemaciclib
- Nivolumab (genetical recombination)
- Baloxavir marboxil
- Revision of Precautions (No. 304)
- Eletriptan hydrobromide
- Zolmitriptan
- Naratriptan hydrochloride
- Rizatriptan benzoate (and 6 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [335 KB] |
| June 4, 2019 |
363 |
- Direct Patient Reporting System for Adverse Drug Reactions
- Research Project on Development of Educational Programs for Healthcare Professionals who Engage in Interviews with Patients about Sensitive Matters
- Important Safety Information
- Dulaglutide (genetical recombination)
- Empagliflozin
- Nivolumab (genetical recombination)
- Lenvatinib mesilate
- Influenza HA vaccine
- Revision of Precautions (No. 303)
Dulaglutide (genetical recombination) (and 11 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [504 KB] |
| April 16, 2019 |
362 |
- Guidelines for Prescription Drug Marketing Information Provision
- Revision of Package Inserts of Intravenous Injection Products Containing Sorbitol or Fructose as Excipient for Use in Patients with Hereditary Fructose Intolerance
- Important Safety Information
- Baloxavir marboxil
- Quetiapine fumarate
- (1) Vonoprazan fumarate
(2) Vonoprazan fumarate/amoxicillin hydrate/clarithromycin
(3) Vonoprazan fumarate/amoxicillin hydrate/metronidazole
- Revision of Precautions (No. 302)
Oseltamivir phosphate (and 7 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [556 KB] |
