BIMATOPROST/TIMOLOL MYLAN
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1720189
Name of medicinal product:
BIMATOPROST/TIMOLOL MYLAN
Active substances:
Timolol+Bimatoprost
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 17 March 2023)
Package information leaflet (PIL):
EST
(last updated 17 March 2023)
Labelling:
(last updated 28 September 2021)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Mylan Pharmaceuticals Limited
Marketing authorization number:
947317
Marketing authorization issued on:
12 September 2017
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: 17 March 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription