TIOPEX Eye gel Ref.[7532] Active ingredients: Timolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Laboratoires THEA, 12 Rue Louis Blรฉriot, 63017 Clermont-Ferrand Cedex 2, FRANCE

Product name and form

TIOPEX 1 mg/g, eye gel in single-dose container.

Pharmaceutical Form

Eye gel in single-dose container.

Opalescent, colourless to slightly yellow gel.

Qualitative and quantitative composition

1 g of gel contains 1 mg of timolol as timolol maleate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Timolol

Timolol is a non-selective beta-adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anaesthetic activity. Timolol reduces intra-ocular pressure, whether or not this is associated with glaucoma.

List of Excipients

Sorbitol
Polyvinyl alcohol
Carbomer 974 P
Sodium acetate trihydrate
Lysine monohydrate
Water for injections

Pack sizes and marketing

10 single-dose containers (PEBD) containing 0.4 g of gel are packed in sachet (paper/aluminium), box of 3 or 9 sachets.

A pack size contains 30 (3x10) or 90 (9x10) single-dose containers.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratoires THEA, 12 Rue Louis Blรฉriot, 63017 Clermont-Ferrand Cedex 2, FRANCE

Marketing authorization dates and numbers

PL 20162/0010

16/04/2010

Drugs

Drug Countries
TIOPEX United Kingdom

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