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`Santen/Asahi Glass Exhibit 2053
`Micro Labs v. Santen Pharm. and Asahi Glass
`IPR2017-01434
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`Exhibit 1
`Exhibit 1
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`IPR Page 2/5
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`Tafluprost
`
`Pharmaceuticals and Medical Devices Agency
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`Generic name
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`Tafluprost
`
`Close window
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`–
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`+
`
`++
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`Font
`Size
`
`Trade name
`
`Manufacturer, etc.
`
`Package
`Insert
`
`Patient
`Drug
`Guide
`
`Kusuri No Shiori
`[Drug Information
`Sheet]
`
`Interview
`form
`
`Disease Response Manual
`for Serious Side-Effects
`
`Tapros ophthalmic
`solution
`
`Maker: Santen
`Pharmaceutical Co., Ltd.
`
`Tapros Mini ophthalmic
`solution 0.0015%
`Tapros ophthalmic
`solution 0.0015%
`
`
`Approval information
`Reports concerning the
`applicability of Kouchi-
`shinsei (public knowledge-
`based application)
`
`
`Approval date, etc.
`
`Report
`
`October 16, 2008
`
`Investigation report 2
`
`Application materials
`summary
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`Application materials
`summary
`
`Remarks
`
`Drug containing new active ingredient with efficacy
`against glaucoma and ocular hypertension
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`Emergency safety data
`Safety reports, etc.
`
`Published on
`
`Revision instructions
`Investigation reports
`Drug and Medical Device
`Safety Data
`DSU
`etc.
`
`Published on
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`February 28, 2017
`
`November 1, 2011
`
`November 1, 2010
`
`Notice on Proper Use of
`Drug
`PMDA Medical Safety
`Data
`etc.
`
`Published on
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`
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`Evaluation risk and other
`information, etc.
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`
`
`Listed on
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`Document Title
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`Document Title
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`Document Title
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`Document Title
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`IPR Page 3/5
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`Exhibit 2
`Exhibit 2
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`IPR Page 4/5
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`IPR Page 4/5
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