Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
BIMATOPROST/TIMOLOL MYLAN
|
Active substances:
|
|
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 March 17, 2023)
|
Package information leaflet (PIL):
|
EST (last updated March 17, 2023)
|
Labelling:
|
(last updated September 28, 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 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
|
Assessment report:
|
(last updated September 12, 2017)
|
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
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