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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1720178
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Name of medicinal product:
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BIMATOPROST/TIMOLOL MYLAN
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Active substances:
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ATC code:
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S01ED82
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Dosage form:
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eye drops, solution
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Route of administration:
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ocular use
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Strengh:
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5mg+0,3mg 1ml
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Amount in package:
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3ml 1TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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Reduction of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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 (last updated March 17, 2023)
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Package information leaflet (PIL):
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EST (last updated March 17, 2023)
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Labelling:
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(last updated September 28, 2021)
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Last imported to Estonia:
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February 21, 2023
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Marketing authorization holder:
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Mylan Pharmaceuticals Limited
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Marketing authorization number:
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947317
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Marketing authorization issued on:
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September 12, 2017
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Decentralised
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Percent
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Valid from
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Valid until
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Valid
|
Diagnosis
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Doctor's speciality
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Primary
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Age
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Other
|
|
100
|
01.04.2023
|
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Yes
|
H40-H42
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Oftalmoloog
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Yes
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until 4 years
|
|
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50
|
01.04.2023
|
|
Yes
|
|
|
No
|
|
|
|
100
|
01.04.2023
|
|
Yes
|
H40-H42
|
Oftalmoloog
|
Yes
|
|
|
|
100
|
01.04.2023
|
|
Yes
|
|
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No
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until 4 years
|
|
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Reference price:
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7,50 EUR
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Under reference price:
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Yes
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Reference price of daily dose:
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0,25 EUR
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Entry/Changing date:
March 17, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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