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01 22care4

02 2Delfran

03 5FINOX BIOTECH AG

04 9Ferring Pharmaceuticals

05 5Gedeon Richter

06 2Health Biotech

07 8IBSA FARMACEUTICI ITALIA Srl

08 10IBSA Farmaceutici Italy S.r.l.

09 6IBSA Institut Biochimique

10 6Merck & Co

11 16Merck Serono

12 3ORIFARM GROUP AS

13 2Sanzyme

14 6Teva Pharmaceutical Industries

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PharmaCompass

01

FNCE
Not Confirmed
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FNCE
Not Confirmed

UROFOLLITROPIN

Brand Name : BRAVELLE

Dosage Form : INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS

Dosage Strength : 75 IU/VIAL

Packaging :

Approval Date :

Application Number : 21289

Regulatory Info :

Registration Country : USA

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02

FNCE
Not Confirmed
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FNCE
Not Confirmed

UROFOLLITROPIN

Brand Name : BRAVELLE

Dosage Form : Injectable; Subcutaneous

Dosage Strength : 0.9%

Packaging :

Approval Date :

Application Number : 21484

Regulatory Info :

Registration Country : USA

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03

FNCE
Not Confirmed
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FNCE
Not Confirmed

UROFOLLITROPIN

Brand Name : METRODIN

Dosage Form : INJECTABLE;INTRAMUSCULAR

Dosage Strength : 75 IU/AMP

Packaging :

Approval Date :

Application Number : 19415

Regulatory Info :

Registration Country : USA

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04

FNCE
Not Confirmed
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FNCE
Not Confirmed

UROFOLLITROPIN

Brand Name : METRODIN

Dosage Form : INJECTABLE;INTRAMUSCULAR

Dosage Strength : 150 IU/AMP

Packaging :

Approval Date :

Application Number : 19415

Regulatory Info :

Registration Country : USA

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05

FNCE
Not Confirmed
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FNCE
Not Confirmed

UROFOLLITROPIN

Brand Name : FERTINEX

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 150 IU/AMP

Packaging :

Approval Date :

Application Number : 19415

Regulatory Info :

Registration Country : USA

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06

FNCE
Not Confirmed
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FNCE
Not Confirmed

UROFOLLITROPIN

Brand Name : FERTINEX

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 75 IU/AMP

Packaging :

Approval Date :

Application Number : 19415

Regulatory Info :

Registration Country : USA

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07

FNCE
Not Confirmed
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FNCE
Not Confirmed

Urofollitropin

Brand Name : Gonal F

Dosage Form : Follitropin Alfa, Recombinant Dna 1.050Iu/1.75Ml 2Ml 1 Units Parenteral Use

Dosage Strength : 1 ampoule SC 1,050 IU 1.75 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

FNCE
Not Confirmed
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FNCE
Not Confirmed

Urofollitropin

Brand Name : Gonal F

Dosage Form : Follitropin Alfa, Recombinant Dna 300Iu 0,5Ml 1 Unit Parenteral Use

Dosage Strength : 1 pen SC 300 IU/0.5 ml + 8 needles

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

FNCE
Not Confirmed
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FNCE
Not Confirmed

Urofollitropin

Brand Name : Gonal F

Dosage Form : Follitropin Alfa, Recombinant Dna 450Iu 0.75Ml 1 Units Parenteral Use

Dosage Strength : 1 pen SC 450 IU/0.75 ml + 12 needles

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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10

FNCE
Not Confirmed
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FNCE
Not Confirmed

Urofollitropin

Brand Name : Gonal F

Dosage Form : Follitropin Alfa, Recombinant Dna 75Iu 1Ml 1 Units Parenteral Use

Dosage Strength : 1 ampoule SC 75 IU + 1 syringe 1 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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11

FNCE
Not Confirmed
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FNCE
Not Confirmed

Urofollitropin

Brand Name : Gonal F

Dosage Form : Follitropin Alfa, Recombinant Dna 75Iu 1Ml 10 Units Parenteral Use

Dosage Strength : 10 VIALS SC 75 IU + 10 SYRINGES 1 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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12

FNCE
Not Confirmed
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FNCE
Not Confirmed

Urofollitropin

Brand Name : Gonal F

Dosage Form : Follitropin Alfa, Recombinant Dna 900Iu 1.5 Ml 1 Units Parenteral Use

Dosage Strength : 1 pen SC 900 IU/1.5 ml + 20 needles

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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13

FNCE
Not Confirmed
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FNCE
Not Confirmed

Urofollitropin

Brand Name : Ovaleap

Dosage Form : Follitropin Alfa, Recombinant Dna 300Iu 0,5Ml 1 Unit Parenteral Use

Dosage Strength : 1 cartridge SC 300 IU/0.5 ml + 10 needles

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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14

FNCE
Not Confirmed
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FNCE
Not Confirmed

Urofollitropin

Brand Name : Ovaleap

Dosage Form : Follitropin Alfa, Recombinant Dna 450Iu 0.75Ml 1 Units Parenteral Use

Dosage Strength : 1 cartridge SC 450 IU/0.75 ml + 10 needles

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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15

FNCE
Not Confirmed
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FNCE
Not Confirmed

Urofollitropin

Brand Name : Ovaleap

Dosage Form : Follitropin Alfa, Recombinant Dna 900Iu 1.5 Ml 1 Units Parenteral Use

Dosage Strength : 1 cartridge SC 900 IU/1.5 ml + 20 needles

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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16

FINOX BIOTECH AG

Country
FNCE
Not Confirmed
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FINOX BIOTECH AG

Country
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FNCE
Not Confirmed

Urofollitropin

Brand Name : Bemfola

Dosage Form : Follitropin Alfa, Recombinant Dna 75Iu 0,125Ml 1 Units Parenteral Use

Dosage Strength : 1 cartridge in the pen preriemp SC 75 IU/0.125 ml + needle

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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17

FINOX BIOTECH AG

Country
FNCE
Not Confirmed
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FINOX BIOTECH AG

Country
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FNCE
Not Confirmed

Urofollitropin

Brand Name : Bemfola

Dosage Form : Follitropin Alfa, Recombinant Dna 300Iu 0,5Ml 1 Unit Parenteral Use

Dosage Strength : 1 cartridge in the pen preriemp SC 300 IU/0.50 ml + needle

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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18

FINOX BIOTECH AG

Country
FNCE
Not Confirmed
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FINOX BIOTECH AG

Country
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FNCE
Not Confirmed

Urofollitropin

Brand Name : Bemfola

Dosage Form : Follitropin Alfa, Recombinant Dna 450Iu 0.75Ml 1 Units Parenteral Use

Dosage Strength : 1 cartridge in the pen preriemp SC 450 IU/0.75 ml + needle

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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19

FINOX BIOTECH AG

Country
FNCE
Not Confirmed
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FINOX BIOTECH AG

Country
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FNCE
Not Confirmed

Urofollitropin

Brand Name : Bemfola

Dosage Form : Follitropin Alfa, Recombinant Dna 150Iu 0.25Ml 1 Units Parenteral Use

Dosage Strength : 1 cartridge in the pen preriemp SC 150 IU/0.25 ml + needle

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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20

FINOX BIOTECH AG

Country
FNCE
Not Confirmed
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FINOX BIOTECH AG

Country
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FNCE
Not Confirmed

Urofollitropin

Brand Name : Bemfola

Dosage Form : Follitropin Alfa, Recombinant Dna 225Iu 0,375Ml 1 Units Parenteral Use

Dosage Strength : 1 cartridge in the pen preriemp SC 225 IU/0.375 ml + needle

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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