CELLCEPT Capsules, hard Ref.[8144] Active ingredients: Mycophenolate mofetil

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

Product name and form

CellCept 250 mg capsules.

Pharmaceutical Form

Capsules, hard.

CellCept capsules: oblong, blue/brown, branded with black “CellCept 250” on the capsule cap and “Roche” name on the capsule body.

Qualitative and quantitative composition

Each capsule contains 250 mg mycophenolate mofetil.

Excipient(s) with known effect: Sodium less than 1 mmol (23 mg) per dose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mycophenolate mofetil

Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA). MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA.
List of Excipients

CellCept capsules:

Pregelatinised maize starch
Croscarmellose sodium
Polyvidone (K-90)
Magnesium stearate

Capsule shells:

Gelatin
Indigo carmine (E132)
Yellow iron oxide (E172)
Red iron oxide (E172)
Titanium dioxide (E171)
Black iron oxide (E172)
Potassium hydroxide
Shellac

Pack sizes and marketing

CellCept 250 mg capsules:

  • 1 carton contains 100 capsules (in blister packs of 10)
  • 1 carton contains 300 capsules (in blister packs of 10)

Not all pack sizes may be marketed.

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

Marketing authorization dates and numbers

EU/1/96/005/001 CellCept (100 capsules)
EU/1/96/005/003 CellCept (300 capsules)

Date of first authorisation: 14 February 1996
Date of latest renewal: 13 March 2006

Drugs

Drug Countries
CELLCEPT Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa
 
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