What Natriumrisedronaat Sandoz 75 mg contains
- The active substance is risedronate sodium. Each tablet contains 75 mg risedronate sodium, equivalent to 69.6 mg risedronic acid.
- The other ingredients are lactose monohydrate, maize starch, sarch pregelatinized (maize), silica colloidal anhydrous (E551), sodium stearyl fumarate (E470a) and magnesium stearate (E572) in the tablet core, and Opadry Pink 03B34103 containing hypromellose 6 cP (E464), titanium dioxide (E171), macrogol 400 and iron oxide red (E172) in the film-coating.
What Natriumrisedronaat Sandoz 75 mg looks like and contents of the pack
- Film-coated tablet
- Pink, round, biconvex, film-coated tablet engraved “R 75” on one side and plain on the other.
- The tablets are supplied in blister packs of 2, 4, 6, 8 or 12 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz B.V., Veluwezoom 22, Almere
Correspondentie: Postbus 10332, 1301 AH Almere
Manufacturers:
Pharmachemie B,V, Swensweg 5, 2301 GA Haarlem, The Netherlands
Teva Sante, Tue Bellocier, 89107 Sens, Immeuble Palatin 1, 1 Cour de Triangle, 92936 Paris La Défense Cedex, France
Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debreccen, Hungary
Teva Pharmaceutical Works Private Limited Company, Táncsics Mihály út 82, H-2100 Gödöllö, Hungary
Lek d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Lek S.A., UL. Domaniewska 50 C, 02-672 Warszawa, Poland
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany
S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania Natriumrisedronaat Sandoz 75 mg is in het register ingeschreven onder RVG 107940.
This medicinal product is authorised in the Member States of the EEA under the following
names:
DE: Risedronsäure – 1A Pharma 75 mg Filmtabletten
NL : Natriumrisedronaat Sandoz 75 mg, filmomhulde tabletten
This leaflet was last approved per November 2013