BIMATOPROST/TIMOLOL MYLAN
General data
Product class:
Medicinal product with marketing authorization
Medicinal product class:
Human medicine
Name of medicinal product:
BIMATOPROST/TIMOLOL MYLAN
Active substances:
Timolol+Bimatoprost
Estonian
,
English
,
Latin
ATC code:
S01ED82
Dosage form:
eye drops, solution
Strength:
5mg+0,3mg 1ml
Legal status for supply*:
Subject to medicinal prescription
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)
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
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
Assessment report:
(last updated 12 September 2017)
Packages approved by this marketing authorization
Package code
Name of medicinal product
Dosage form
Package
Legal status
Reimbursements
Reference price
Last imported
PƤritolumaa
Additional information
1720178
BIMATOPROST/TIMOLOL MYLAN
eye drops, solution
5mg +0,3mg 1ml 3ml 1TK
Prescription
100% 50%
7.50
21/02/2023
1720189
BIMATOPROST/TIMOLOL MYLAN
eye drops, solution
5mg +0,3mg 1ml 3ml 3TK
Prescription
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription