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01 1Cycle Pharmaceuticals (Europe) Limited

02 4DIPHARMA ARZNEIMITTEL GMBH

03 8Dipharma Arzneimittel Gmbh

04 7Mendelikabs Europe Limited

05 2Nobel Ilac Sanayii Ve Ticaret A.S.

06 3SWEDISH ORPHAN BIOVITR.INT.AB

07 4SWEDISH ORPHAN BIOVITRUM INTERNATIONAL AB

08 2Swedish Orphan Biovitrum International AB

09 10Swedish Orphan Biovitrum International Ab

10 3Swedish Orphan International AB

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PharmaCompass

01

FNCE
Not Confirmed
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FNCE
Not Confirmed

Nitisinone

Brand Name : Tisinon

Dosage Form : Capsule

Dosage Strength : 5MG

Packaging : 60 Capsules

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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02

FNCE
Not Confirmed
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FNCE
Not Confirmed

Nitisinone

Brand Name : Tisinon

Dosage Form : Capsule

Dosage Strength : 10MG

Packaging : 60 Capsules

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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03

FNCE
Not Confirmed
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FNCE
Not Confirmed

Nitisinone

Brand Name : Orfadin

Dosage Form : Nitisinone 2Mg 60 Units Oral Use

Dosage Strength : 60 cps 2 mg bottle

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

FNCE
Not Confirmed
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FNCE
Not Confirmed

Nitisinone

Brand Name : Orfadin

Dosage Form : Nitisinone 5Mg 60 Units Oral Use

Dosage Strength : 60 cps 5 mg bottle

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

FNCE
Not Confirmed
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FNCE
Not Confirmed

Nitisinone

Brand Name : Orfadin

Dosage Form : Nitisinone 10Mg 60 Units Oral Use

Dosage Strength : 60 cps 10 mg vial

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

FNCE
Not Confirmed
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FNCE
Not Confirmed

Nitisinone

Brand Name : Orfadin

Dosage Form : Capsule, hard

Dosage Strength : 10 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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07

FNCE
Not Confirmed
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FNCE
Not Confirmed

Nitisinone

Brand Name : Orfadin

Dosage Form : Capsule, hard

Dosage Strength : 2 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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08

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FNCE
Not Confirmed

Nitisinone

Brand Name : Orfadin

Dosage Form : Capsule, hard

Dosage Strength : 20 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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09

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FNCE
Not Confirmed

Nitisinone

Brand Name : Orfadin

Dosage Form : Potion, suspension

Dosage Strength : 4 mg/ml

Packaging : Bottle of glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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10

FNCE
Not Confirmed
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FNCE
Not Confirmed

Nitisinone

Brand Name : Orfadin

Dosage Form : Capsule, hard

Dosage Strength : 5 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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