Lopinavir | All | Licensing, EU CTD Dossiers, Formulation Suppliers

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U.S.A

Regulatory Info : DISCN

Registration Country : USA

Brand Name : KALETRA

Dosage Form : CAPSULE;ORAL

Dosage Strength : 133.3MG;33.3MG

Packaging :

Approval Date : 2000-09-15

Application Number : 21226

Regulatory Info : DISCN

Registration Country : USA

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02

AbbVie Inc

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U.S.A

Regulatory Info : RX

Registration Country : USA

Brand Name : KALETRA

Dosage Form : SOLUTION;ORAL

Dosage Strength : 80MG/ML;20MG/ML

Packaging :

Approval Date : 2000-09-15

Application Number : 21251

Regulatory Info : RX

Registration Country : USA

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03

AbbVie Inc

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U.S.A

Regulatory Info : RX

Registration Country : USA

Brand Name : KALETRA

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG;50MG

Packaging :

Approval Date : 2005-10-28

Application Number : 21906

Regulatory Info : RX

Registration Country : USA

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04

AbbVie Inc

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U.S.A

Regulatory Info : RX

Registration Country : USA

Brand Name : KALETRA

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG;25MG

Packaging :

Approval Date : 2007-11-09

Application Number : 21906

Regulatory Info : RX

Registration Country : USA

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05

AbbVie Inc

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U.S.A

Regulatory Info :

Registration Country : Italy

Brand Name : Kaletra

Dosage Form : Lopinavir + Ritonavir 100+25Mg 60 Units Oral Use

Dosage Strength : 60 cpr riv 100 mg + 25 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

AbbVie Inc

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U.S.A

Regulatory Info :

Registration Country : Italy

Brand Name : Kaletra

Dosage Form : Lopinavir + Ritonavir 200+50Mg 120 Unita' Oral Use

Dosage Strength : 120 cpr riv 200 mg + 50 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

AbbVie Inc

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U.S.A

Regulatory Info :

Registration Country : Italy

Brand Name : Kaletra

Dosage Form : Lopinavir + Ritonavir 80Mg/Ml + 20Mg/Ml 60Ml 5 Units' Oral Use

Dosage Strength : os soluz 5 vials of 60 ml 80 mg/ml + 20 mg/ml + 5 Syringes

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

AbbVie Inc

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U.S.A

Regulatory Info :

Registration Country : Norway

Lopinavir

Brand Name : Kaletra

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 100 mg/25 mg

Packaging : Box

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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09

AbbVie Inc

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U.S.A

Regulatory Info :

Registration Country : Norway

Lopinavir

Brand Name : Kaletra

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 200 mg/50 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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10

AbbVie Inc

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U.S.A

Regulatory Info :

Registration Country : Norway

Lopinavir

Brand Name : Kaletra

Dosage Form : Melange

Dosage Strength : 80 mg/ml/20 mg/ml

Packaging : Bottle of glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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11

AbbVie Inc

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U.S.A

Regulatory Info : Deregistered

Registration Country : Sweden

Brand Name : Kaletra

Dosage Form : Capsule

Dosage Strength : 133.3mg;33.3mg

Packaging :

Approval Date : 20/03/2001

Application Number : 20010320000028

Regulatory Info : Deregistered

Registration Country : Sweden

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12

AbbVie Inc

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U.S.A

Regulatory Info : Approved

Registration Country : Sweden

Lopinavir Ritonavir

Brand Name : Kaletra

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg;25mg

Packaging :

Approval Date : 18/03/2008

Application Number : 20070625000017

Regulatory Info : Approved

Registration Country : Sweden

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13

AbbVie Inc

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U.S.A

Regulatory Info : Approved

Registration Country : Sweden

Lopinavir Ritonavir

Brand Name : Kaletra

Dosage Form : Film Coated Tablet

Dosage Strength : 200mg;50mg

Packaging :

Approval Date : 27/06/2006

Application Number : 20050719000031

Regulatory Info : Approved

Registration Country : Sweden

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14

AbbVie Inc

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U.S.A

Regulatory Info : Approved

Registration Country : Sweden

Brand Name : Kaletra

Dosage Form : Oral Solution

Dosage Strength : 80mg/ml;20mg/ml

Packaging :

Approval Date : 20/03/2001

Application Number : 20010320000035

Regulatory Info : Approved

Registration Country : Sweden

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15

AbbVie Inc

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U.S.A

Regulatory Info : Allowed

Registration Country : Switzerland

Brand Name : Kaletra

Dosage Form : Syrup

Dosage Strength :

Packaging :

Approval Date : 13/12/2000

Application Number : 55649

Regulatory Info : Allowed

Registration Country : Switzerland

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16

AbbVie Inc

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U.S.A

Regulatory Info : Allowed

Registration Country : Switzerland

Brand Name : Kaletra

Dosage Form : Film Coated Tablet

Dosage Strength : 200mg;50mg

Packaging :

Approval Date : 22/08/2006

Application Number : 57555

Regulatory Info : Allowed

Registration Country : Switzerland

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17

AbbVie Inc

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U.S.A

Regulatory Info : Allowed

Registration Country : Switzerland

Brand Name : Kaletra

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg;25mg

Packaging :

Approval Date : 22/08/2006

Application Number : 57555

Regulatory Info : Allowed

Registration Country : Switzerland

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18

AbbVie Inc

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U.S.A

Regulatory Info : Prescription

Registration Country : Canada

LOPINAVIR

Brand Name : KALETRA

Dosage Form : SOLUTION

Dosage Strength : 400MG/5ML

Packaging : 160ML

Approval Date :

Application Number : 2243644

Regulatory Info : Prescription

Registration Country : Canada

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19

AbbVie Inc

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U.S.A

Regulatory Info : Prescription

Registration Country : Canada

LOPINAVIR

Brand Name : KALETRA

Dosage Form : TABLET

Dosage Strength : 200MG

Packaging : 120

Approval Date :

Application Number : 2285533

Regulatory Info : Prescription

Registration Country : Canada

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20

AbbVie Inc

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U.S.A

Regulatory Info : Prescription

Registration Country : Canada

LOPINAVIR

Brand Name : KALETRA

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging : 60

Approval Date :

Application Number : 2312301

Regulatory Info : Prescription

Registration Country : Canada

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