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Approved Marketing Authorisations (MA) containing Tox21_300269 in Europe. Original Data : EMA Website

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01 1Orion Corporation

02 5Orion Corporation - Espoo

03 1Orion Corporation, Orion Pharma

04 8ACCORD HEALTHCARE SLU

05 5ALFA WASSERMANN SpA

06 8ALFASIGMA SPA

07 18Accord Healthcare AG

08 6Accord Healthcare Ltd.

09 11Actavis Group PTC ehf.

10 1Astron Research Ltd

11 1Atabay Kimya Sanayi ve Ticaret A.S.

12 1Cipla Europe NV

13 2Cipla Europe NV,

14 6DIFA COOPER SPA

15 6DOC GENERICI SRL

16 7DOC GENERICI Srl

17 11DOC Generici Srl,

18 7EBEWE Pharma Ges.m.b.H Nfg. KG

19 1EBEWE Pharma Ges.m.b.H.Nfg.KG

20 5EBEWE Pharma Ges.mbHNfg.KG

21 17Gebro Pharma AG

22 3HOSPIRA ITALIA Srl

23 1Ideogen AG

24 17Medac - Gesellschaft für klinische Spezialpräparate Gmbh - Wedel

25 14Medac Gesellschaft für klinische Spezialpräparate mbH, Hamburg

26 7Mepha Pharma AG

27 1Mylan Hospital AS

28 8Nordic Group BV

29 16Nordic Pharma GmbH

30 3Orifarm AS

31 4Orion Pharma AG

32 9PFIZER ITALIA Srl

33 1Paranova Läkemedel AB

34 3Pfizer AB

35 1Pfizer AG

36 2Pfizer AS

37 6S.F.GROUP Srl

38 2SANDOZ SpA

39 12SF GROUP SRL

40 13Sandoz Pharmaceuticals AG

41 22Sigillata Ltd

42 11Sigillata Ltd.

43 4TEVA PHARMA B.V.

44 3Teva Pharma AG

45 7Teva Sweden AB

46 11Visufarma Spa

47 27medac Gesellschaft für

48 22Blank

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PharmaCompass

01

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AAPS 2024
Not Confirmed

metotrexat

Brand Name : Methotrexate Orion

Dosage Form : TABLETT

Dosage Strength : 2,5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Fermion Orion Company Banner

02

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AAPS 2024
Not Confirmed

metotrexat

Brand Name : Methotrexate Orion

Dosage Form : INJEKTIONSVÄTSKA, LÖSNING, FÖRFYLLD SPRUTA

Dosage Strength : 25 MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Fermion Orion Company Banner

03

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AAPS 2024
Not Confirmed

Methotrexate

Brand Name : Methotrexate Orion

Dosage Form : Injection fluid, resolution in the finished filled syringe

Dosage Strength : 25 mg/ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

04

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AAPS 2024
Not Confirmed

Methotrexate

Brand Name : Methotrexate Orion

Dosage Form : Injection fluid, resolution in the finished filled syringe

Dosage Strength : 25 mg/ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

05

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AAPS 2024
Not Confirmed

Methotrexate

Brand Name : Methotrexate Orion

Dosage Form : Injection fluid, resolution in the finished filled syringe

Dosage Strength : 25 mg/ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

06

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AAPS 2024
Not Confirmed

Methotrexate

Brand Name : Methotrexate Orion

Dosage Form : Injection fluid, resolution in the finished filled syringe

Dosage Strength : 25 mg/ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

07

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AAPS 2024
Not Confirmed

Methotrexate

Brand Name : Methotrexate Orion

Dosage Form : Injection fluid, resolution in the finished filled syringe

Dosage Strength : 25 mg/ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Fermion Orion Company Banner

08

Sigillata Ltd.

Country
AAPS 2024
Not Confirmed
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Sigillata Ltd.

Country
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AAPS 2024
Not Confirmed

methotrexate

Brand Name : Afslamet

Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE

Dosage Strength : 12.5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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09

Sigillata Ltd.

Country
AAPS 2024
Not Confirmed
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Sigillata Ltd.

Country
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AAPS 2024
Not Confirmed

methotrexate

Brand Name : Afslamet

Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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10

Sigillata Ltd.

Country
AAPS 2024
Not Confirmed
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Sigillata Ltd.

Country
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AAPS 2024
Not Confirmed

methotrexate

Brand Name : Afslamet

Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE

Dosage Strength : 17.5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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