Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1720189
Name of medicinal product: BIMATOPROST/TIMOLOL MYLAN
Active substances:
Estonian, English, Latin
ATC code: S01ED82
Dosage form: eye drops, solution
Route of administration: ocular use
Strengh: 5mg+0,3mg 1ml
Amount in package: 3ml 3TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: 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.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated March 17, 2023)
Package information leaflet (PIL): EST  (last updated March 17, 2023)
Labelling:  (last updated September 28, 2021)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Mylan Pharmaceuticals Limited 
Marketing authorization number: 947317 
Marketing authorization issued on: September 12, 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
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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