ATIVAN Solution for injection Ref.[6969] Active ingredients: Lorazepam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Product name and form

Ativan 4mg/ml Solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, colourless solution supplied in clear glass ampoules.

Qualitative and quantitative composition

Lorazepam 4 mg/ml.

Lorazepam (INN, BAN) is chemically defined as 7-chloro-5-(o-chlorphenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one.

Excipient(s) with known effect: Ativan Injection contains 20.9mg/ml benzyl alcohol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lorazepam

Lorazepam is a benzodiazepine with anxiolytic, sedative and hypnotic properties.

List of Excipients

Polyethylene glycol 400
Benzyl alcohol
Propylene glycol

Pack sizes and marketing

1ml solution in 2ml ampoules (Type I glass) with a one-point-cut opening, position marked by red spot in pack sizes of 10.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/1279

Date of latest renewal: 12 March 2009

Drugs

Drug Countries
ATIVAN Ecuador, Estonia, Ireland, Malta, Mexico, New Zealand, Turkey, United States, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.