STRONTIUM RANELATE ARISTO Granules Ref.[8499] Active ingredients: Strontium ranelate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Aristo Pharma GmbH, Wallenroder StraรŸe 8-10, 13435, Berlin, Germany

Product name and form

Strontium ranelate Aristo 2 g granules for oral suspension.

Pharmaceutical Form

White to beige granules for oral suspension.

Qualitative and quantitative composition

Each sachet contains 2 g of strontium ranelate.

Excipient with known effect: Each sachet also contains 20 mg of aspartame (E951).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Strontium ranelate

In vitro, strontium ranelate increases bone formation in bone tissue culture as well as osteoblast precursor replication and collagen synthesis in bone cell culture and reduces bone resorption by decreasing osteoclast differentiation and resorbing activity. This results in a rebalance of bone turnover in favour of bone formation.

List of Excipients

Mannitol (E421)
Maltodextrin
Aspartame (E951)
Vanillin

Pack sizes and marketing

Polyethylene/aluminium/paper sachets.

Pack sizes: boxes containing 14, 28 or 84 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

Aristo Pharma GmbH, Wallenroder StraรŸe 8-10, 13435, Berlin, Germany

Marketing authorization dates and numbers

PL 40546/0019

03/01/2018

ยฉ 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.