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01 3Accord Healthcare S.L.

02 3Accord Healthcare SLU

03 6Accord Healthcare Slu

04 5Hexal A/S

05 2OTSUKA PHARMAC.EUROPE LTD

06 3OTSUKA PHARMACEUTICAL NETHERLANDS BV

07 3Orifarm AS

08 8Otsuka Pharmaceutical (Switzerland) Gmbh

09 8Otsuka Pharmaceutical Netherlands B.V.

10 7Otsuka Pharmaceutical Netherlands BV

11 27Otsuka Pharmaceutical Netherlands Bv

12 3Sandoz A/S

13 3TEVA BV

14 4Teva BV

15 17Teva Bv

16 8Zentiva Ks

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PharmaCompass

01

IPPE
Not Confirmed
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IPPE
Not Confirmed

Tolvaptan

Brand Name : Samsca

Dosage Form : Tolvaptan 15Mg 10 Units Oral Use

Dosage Strength : 10 CPR 15 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

IPPE
Not Confirmed
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IPPE
Not Confirmed

Tolvaptan

Brand Name : Samsca

Dosage Form : Tolvaptan 30Mg 10 Units Oral Use

Dosage Strength : 10 CPR 30 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

IPPE
Not Confirmed
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IPPE
Not Confirmed

Tolvaptan

Brand Name : JINARC

Dosage Form : Tablet

Dosage Strength : 15 mg + 45 mg

Packaging : 28 UNITS 15 MG + 28 UNITS 45 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

IPPE
Not Confirmed
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IPPE
Not Confirmed

Tolvaptan

Brand Name : JINARC

Dosage Form : Tablet

Dosage Strength : 30 mg + 60 mg

Packaging : 28 UNITA' 30 MG + 28 UNITA' 60 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

IPPE
Not Confirmed
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IPPE
Not Confirmed

Tolvaptan

Brand Name : JINARC

Dosage Form : Tablet

Dosage Strength : 30 mg + 90 mg

Packaging : 28 UNITA' 30 MG + 28 UNITA' 90 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

IPPE
Not Confirmed
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IPPE
Not Confirmed

Tolvaptan

Brand Name : Jinarc

Dosage Form : Tablet

Dosage Strength : 15mg

Packaging :

Approval Date : 27/05/2015

Application Number : 20140109000021

Regulatory Info : Approved

Registration Country : Sweden

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07

IPPE
Not Confirmed
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IPPE
Not Confirmed

Tolvaptan

Brand Name : Jinarc

Dosage Form : Tablet

Dosage Strength : 30mg

Packaging :

Approval Date : 27/05/2015

Application Number : 20140109000038

Regulatory Info : Approved

Registration Country : Sweden

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08

IPPE
Not Confirmed
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IPPE
Not Confirmed

Tolvaptan

Brand Name : TOLVAPTAN TEVA

Dosage Form : Tablet

Dosage Strength : 15 mg + 45 mg

Packaging : 28 UNITS 15 MG + 28 UNITS 45 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

IPPE
Not Confirmed
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IPPE
Not Confirmed

Tolvaptan

Brand Name : TOLVAPTAN TEVA

Dosage Form : Tablet

Dosage Strength : 30 mg + 60 mg

Packaging : 28 UNITA' 30 MG + 28 UNITA' 60 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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10

IPPE
Not Confirmed
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IPPE
Not Confirmed

Tolvaptan

Brand Name : TOLVAPTAN TEVA

Dosage Form : Tablet

Dosage Strength : 30 mg + 90 mg

Packaging : 28 UNITA' 30 MG + 28 UNITA' 90 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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