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01 7Accord healthcare

02 1Acino Pharma

03 5Acorda Therapeutics

04 1Actavis Inc

05 1Alkem Laboratories

06 1Ascent Innovative Medicines

07 1Aurobindo Pharma Limited

08 1Aurovitas Spain, Sau

09 1CinnaGen

10 1Desitin Arzneimittel

11 1Hikma Pharmaceuticals

12 1Intas Pharmaceuticals

13 2Medical Valley

14 7Merz Pharma

15 1Micro Labs Limited

16 3Neuraxpharm

17 2Newbury Pharmaceuticals Ab

18 2ORIFARM GROUP AS

19 1Pharmascience Inc.

20 1Rising Pharmaceuticals Inc

21 1Rontis

22 4STADA Arzneimittel

23 5Sandoz B2B

24 2Sun Pharmaceutical Industries Limited

25 1Taro Pharmaceutical Industries

26 3Teva Pharmaceutical Industries

27 2Viatris

28 2Zentiva

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PharmaCompass

01

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2018-07-11

Application Number : 206863

Regulatory Info : RX

Registration Country : USA

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02

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Fampridin

Brand Name : Fampridine Accord

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 24/09/2020

Application Number : 20190730000051

Regulatory Info : Approved

Registration Country : Sweden

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03

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2017-01-23

Application Number : 206836

Regulatory Info : RX

Registration Country : USA

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04

Alkem Laboratories

SCOPE Summit
Not Confirmed
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Alkem Laboratories

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SCOPE Summit
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2018-07-30

Application Number : 206765

Regulatory Info : RX

Registration Country : USA

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05

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Dalfampridine

Brand Name :

Dosage Form : ER Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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06

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2017-01-23

Application Number : 206811

Regulatory Info : RX

Registration Country : USA

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07

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Dalfampridine

Brand Name : Dalfyra

Dosage Form : Tablet ER.

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

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08

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2018-10-24

Application Number : 206646

Regulatory Info : DISCN

Registration Country : USA

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09

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Dalfampridine

Brand Name :

Dosage Form : SR Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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10

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Fampridin

Brand Name : Fampridin Medical Valley

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 01/09/2022

Application Number : 20190726000034

Regulatory Info : Approved

Registration Country : Sweden

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11

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

DALFAMPRIDINE

Brand Name : AMPYRA

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2010-01-22

Application Number : 22250

Regulatory Info : RX

Registration Country : USA

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12

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2019-03-11

Application Number : 210158

Regulatory Info : RX

Registration Country : USA

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13

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Fampridin

Brand Name : Fampridin Neuraxpharm

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 07/06/2024

Application Number : 20231025000032

Regulatory Info : Approved

Registration Country : Sweden

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14

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2020-07-06

Application Number : 206858

Regulatory Info : DISCN

Registration Country : USA

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15

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Fampridin

Brand Name : Fampridine Sandoz

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 22/09/2022

Application Number : 20190729000116

Regulatory Info : Approved

Registration Country : Sweden

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16

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Fampridin

Brand Name : Fampridine Stada

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 21/06/2022

Application Number : 20190805000047

Regulatory Info : Approved

Registration Country : Sweden

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17

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2019-05-21

Application Number : 208292

Regulatory Info : DISCN

Registration Country : USA

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18

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

DALFAMPRIDINE

Brand Name : DALFAMPRIDINE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 206854

Regulatory Info :

Registration Country : USA

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19

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Fampridin

Brand Name : Fampridin Zentiva

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 22/09/2022

Application Number : 20200306000016

Regulatory Info : Approved

Registration Country : Sweden

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20

Newbury Pharmaceuticals Ab

Country
SCOPE Summit
Not Confirmed
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Newbury Pharmaceuticals Ab

Country
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SCOPE Summit
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Fampridin

Brand Name : Fampridine Newbury

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 23/12/2022

Application Number : 20211027000032

Regulatory Info : Approved

Registration Country : Sweden

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