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01 1Ciprofloxacin Hydrochloride (Monohydrate)
02 2Ciprofloxacin Hydrochloride (Monohydrate); Fluocinolone Acetonide
03 1Fluocinolonacetonid
04 2Naltrexonhydroklorid
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01 4Ear Drops
02 2Film Coated Tablet
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01 1250mcg/ml
02 12mg/ml
03 23mg/ml;0.25mg/ml
04 250mg
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01 6Sweden
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01 1Cetraxal
02 2Cetraxal Comp
03 2Naltrexone Poa Pharma
04 1Otazem
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Regulatory Info : Approved
Registration Country : Sweden
Ciprofloxacin Hydrochloride (Monohydrate)
Dosage Form : Ear Drops
Dosage Strength : 2mg/ml
Packaging :
Brand Name : Cetraxal
Approval Date : 14/02/2013
Application Number : 20120619000087
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Ciprofloxacin Hydrochloride (Monohydrate); Fluocinolone Acetonide
Dosage Form : Ear Drops
Dosage Strength : 3mg/ml;0.25mg/ml
Packaging :
Brand Name : Cetraxal Comp
Approval Date : 16/11/2012
Application Number : 20120418000011
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Ciprofloxacin Hydrochloride (Monohydrate); Fluocinolone Acetonide
Dosage Form : Ear Drops
Dosage Strength : 3mg/ml;0.25mg/ml
Packaging :
Brand Name : Cetraxal Comp
Approval Date : 08/06/2018
Application Number : 20170201000018
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Ear Drops
Dosage Strength : 250mcg/ml
Packaging :
Brand Name : Otazem
Approval Date : 26/03/2018
Application Number : 20170922000014
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg
Packaging :
Brand Name : Naltrexone Poa Pharma
Approval Date : 24/04/2018
Application Number : 20170802000011
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg
Packaging :
Brand Name : Naltrexone Poa Pharma
Approval Date : 01/11/2012
Application Number : 20111008000016
Regulatory Info : Deregistered
Registration Country : Sweden
