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01 4Accord healthcare

02 3Adalvo

03 2Aguettant

04 1Alembic Pharmaceuticals Limited

05 1Aurobindo Pharma Limited

06 1Auxilia Pharma Oü

07 1Avansor Pharma Oy

08 1Caplin Point Laboratories Limited

09 4Cipla

10 3Day Zero Ehf

11 1Day Zero Ehf.

12 1Exeltis

13 4Fresenius Kabi AB Brunna

14 1Fresenius Kabi USA

15 2GP Pharm

16 2GSK

17 1Generic Health

18 3Glenmark Pharmaceuticals

19 1Hansoh Pharma

20 1Hikma Pharmaceuticals

21 1Intas Pharmaceuticals

22 1JAMP PHARMA

23 1Juno Pharmaceuticals Pty Ltd

24 2Medical Valley

25 1Nang Kuang Pharmaceutical Co. Ltd.

26 2Newbury Pharmaceuticals AB

27 2Newbury Pharmaceuticals Ab

28 1Norameda

29 2Piramal Critical Care

30 1Polifarma

31 1SHIRE PLC

32 4STADA Arzneimittel

33 2Sandoz B2B

34 1Spirig Healthcare

35 1Sun Pharmaceutical Industries Limited

36 9Takeda Pharmaceutical

37 6Teva Pharmaceutical Industries

38 1Universal Corporation

39 1Universal Farma S.L.

40 2Viatris

41 1WILSHIRE PHARMS INC

42 2Zentiva

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PharmaCompass

01

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Icatibant Acetate

Brand Name : Icatibant Accord

Dosage Form : Solution For Injection

Dosage Strength : 30mg

Packaging :

Approval Date : 16/07/2021

Application Number : 20200725000017

Regulatory Info : Approved

Registration Country : Sweden

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02

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Icatibant Acetate

Brand Name : Icatibant Aguettant

Dosage Form : Solution For Injection

Dosage Strength : 30mg

Packaging :

Approval Date : 27/12/2021

Application Number : 20200825000092

Regulatory Info : Approved

Registration Country : Sweden

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03

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Packaging :

Approval Date : 2024-06-14

Application Number : 213773

Regulatory Info : RX

Registration Country : USA

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04

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Packaging :

Approval Date : 2023-08-14

Application Number : 213521

Regulatory Info : RX

Registration Country : USA

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05

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Packaging :

Approval Date : 2020-10-05

Application Number : 213054

Regulatory Info : DISCN

Registration Country : USA

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06

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Packaging :

Approval Date : 2020-07-13

Application Number : 212446

Regulatory Info : RX

Registration Country : USA

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07

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Packaging :

Approval Date : 2020-06-18

Application Number : 208317

Regulatory Info : RX

Registration Country : USA

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08

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Packaging :

Approval Date : 2021-05-21

Application Number : 213222

Regulatory Info : DISCN

Registration Country : USA

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09

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Packaging :

Approval Date : 2020-03-09

Application Number : 211021

Regulatory Info : RX

Registration Country : USA

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10

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Icatibant Acetate

Brand Name :

Dosage Form : Pre Filled Syringes

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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11

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Packaging :

Approval Date : 2020-12-16

Application Number : 212081

Regulatory Info : RX

Registration Country : USA

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12

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Icatibant Acetate

Brand Name :

Dosage Form : Injector for SC Injection

Dosage Strength : 30MG/3ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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13

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

ICATIBANT ACETATE

Brand Name : Firazyr

Dosage Form : Icatibant 30Mg 3Ml 1 Units Parenteral Use

Dosage Strength : 1 syringe SC 30 mg 3 ml 10 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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14

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Hurled

Brand Name : Icatibant Spirig HC

Dosage Form : Solution For Injection

Dosage Strength : 30mg

Packaging :

Approval Date : 17/02/2022

Application Number : 68263

Regulatory Info : Allowed

Registration Country : Switzerland

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15

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

ICATIBANT ACETATE

Brand Name : FIRAZYR

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Packaging :

Approval Date : 2011-08-25

Application Number : 22150

Regulatory Info : RX

Registration Country : USA

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16

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Hurled

Brand Name : Firazyr

Dosage Form : Solution For Injection

Dosage Strength : 30mg/3 ml

Packaging :

Approval Date : 17/06/2009

Application Number : 58178

Regulatory Info : Allowed

Registration Country : Switzerland

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17

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Icatibant Acetate

Brand Name : Firazyr

Dosage Form : Solution For Injection

Dosage Strength : 30mg

Packaging :

Approval Date : 11/07/2008

Application Number : 20070804000050

Regulatory Info : Approved

Registration Country : Sweden

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18

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Packaging :

Approval Date : 2019-07-15

Application Number : 210118

Regulatory Info : RX

Registration Country : USA

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19

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

ICATIBANT ACETATE

Brand Name : ICATIBANT ACETATE

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Packaging :

Approval Date : 2020-09-01

Application Number : 211501

Regulatory Info : RX

Registration Country : USA

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20

Day Zero Ehf

Country
SCOPE Summit
Not Confirmed
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Day Zero Ehf

Country
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SCOPE Summit
Not Confirmed

Icatibant Acetate

Brand Name : Despicable

Dosage Form : Solution For Injection

Dosage Strength : 30mg

Packaging :

Approval Date : 11/03/2022

Application Number : 20210126000028

Regulatory Info : Approved

Registration Country : Sweden

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