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Revisions of PRECAUTIONS (FY2019)

Posted date Nonproprietary name
(Click on each drug name for more information
[only available in Japanese language])		 Detailed information on revisions of PRECAUTIONS
(from MHLW)		 Summary of investigation results
(from PMDA)
September 6,
2019		 Romosozumab (genetical recombination) PDF PDF
September 6,
2019		 Trelagliptin succinate PDF PDF
August 22,
2019		 Apomorphine hydrochloride hydrate PDF PDF
Talipexole hydrochloride PDF
Pramipexole hydrochloride hydrate PDF
Pramipexole hydrochloride hydrate PDF
Bromocriptine mesilate
Pergolide mesilate		 PDF
Rotigotine PDF
Ropinirole hydrochloride PDF
Cabergoline PDF PDF
PDF
Tofacitinib citrate PDF PDF
Freeze-dried BCG vaccine PDF PDF
July 17,
2019		 Suxamethonium chloride hydrate
Suxamethonium chloride hydrate		 PDF Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
Etilefrine hydrochloride PDF Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
Phenylephrine hydrochloride PDF
Ozagrel sodium PDF Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
Purified tuberculin
Purified tuberculin		 PDF Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
July 9,
2019		 Febuxostat PDF PDF
Topiroxostat PDF
July 9,
2019		 Epoprostenol sodium PDF PDF
Nivolumab (genetical recombination) PDF PDF
Pembrolizumab (genetical recombination) PDF
Palbociclib PDF PDF
Cedar pollen extract powder
Dermatophagoides pteronyssinus extract/dermatophagoides farina extract		 PDF PDF
Standardized cedar pollen extract (liquid, those for sublingual administration only)
Dermatophagoides pteronyssinus extract bulk powder/dermatophagoides farinae extract bulk powder		 PDF
Tramadol hydrochloride (oral dosage form)
Tramadol hydrochloride/acetaminophen		 PDF Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
Tramadol hydrochloride (injection) PDF
Codeine phosphate hydrate (prescription drugs)
Codeine phosphate hydrate (prescription drugs)
Codeine phosphate hydrate (prescription drugs)
Dihydrocodeine phosphate (prescription drugs)
Dihydrocodeine phosphate (prescription drugs)
Dihydrocodeine phosphate (prescription drugs)		 PDF
Dihydrocodeine phosphate/platycodon fluidextract/glycyrrhiza extract/plantago herb extract/peony root extract (prescription drugs)
Dihydrocodeine phosphate/dl-methylephedrine hydrochloride/ chlorpheniramine maleate (prescription drugs)
Dihydrocodeine phosphate/dl-methylephedrine hydrochloride/ chlorpheniramine maleate (prescription drugs)
Dihydrocodeine phosphate/dl-methylephedrine hydrochloride/ chlorpheniramine maleate (prescription drugs)
Dihydrocodeine phosphate/
diprophylline/dl-methylephedrine hydrochloride/
diphenhydramine salicylate/acetaminophen/bromovalerylurea (prescription drugs)
Dihydrocodeine phosphate/ephedrine hydrochloride/
ammonium chloride (prescription drugs)		 PDF
Products containing codeine phosphate hydrate (OTC drugs)
Products containing dihydrocodeine phosphate (OTC drugs)		 PDF
June 18,
2019		 Metformin Hydrochloride(preparations with a daily maximum dose of 2 250 mg) PDF PDF
Metformin Hydrochloride(preparations with a maximum daily dose of 750 mg) PDF
Anagliptin/metformin hydrochloride PDF
Alogliptin benzoate/metformin hydrochloride PDF
Pioglitazone hydrochloride/metformin hydrochloride PDF
Vildagliptin/metformin hydrochloride PDF
June 4,
2019		 Eletriptan hydrobromide
Zolmitriptan
Naratriptan hydrochloride
Rizatriptan benzoate		 PDF PDF
Sumatriptan
Sumatriptan succinate
Sumatriptan succinate		 PDF
Sumatriptan succinate PDF
Avelumab (genetical recombination) PDF PDF
Nivolumab (genetical recombination) PDF PDF
Pembrolizumab (genetical recombination) PDF
Baloxavir marboxil PDF PDF
May 20,
2019

May 17,
2019
(Originally Posted in Japanese)		 Abemaciclib PDF PDF
May 9,
2019		 Dulaglutide (genetical recombination) PDF PDF
Ipragliflozin L-proline
Tofogliflozin hydrate		 PDF PDF
Empagliflozin PDF
Empagliflozin/linagliptin PDF
Canagliflozin hydrate PDF
Sitagliptin phosphate hydrate/ipragliflozin L-proline PDF
Dapagliflozin propylene glycolate hydrate PDF
Teneligliptin hydrobromide hydrate/canagliflozin hydrate PDF
Luseogliflozin hydrate PDF
Nivolumab (genetical recombination) PDF PDF
Lenvatinib mesilate PDF PDF
Influenza HA vaccine PDF PDF

 

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Revisions of PRECAUTIONS (FY2019)
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