What Myfenax contains:
- The active substance is mycophenolate mofetil. Each capsule contains 250 mg mycophenolate mofetil
- The other ingredients are:
Capsule content:
Pregelatinised maize starch
Povidone K-30
Croscarmellose sodium
Magnesium stearate
Capsule shells:
Cap:
Indigo carmine (E132)
Titanium dioxide (E171)
Gelatin
Body:
Red iron oxide (E172)
Yellow iron oxide (E172)
Titanium dioxide (E171)
Gelatin
Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide
What Myfenax looks like and contents of the pack
Hard capsules:
Body: caramel opaque, printed ?250? axially in black ink.
Cap: light blue opaque printed ?M? axially in black ink.
Myfenax 250 mg hard capsules are available in PVC/PVdC ? aluminium blisters in pack sizes of 100 or 300 or 100 x 1 capsules per carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder
Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands
Manufacturers
Teva Pharmaceutical Works Private Limited Company Pallagi út 13.
Debrecen H-4042
Hungary
TEVA Pharmaceutical Works Private Limited Company H-2100 Gödöll-
Táncsics Mihály út 82
Hungary
TEVA UK Ltd
Brampton Road
Hampden Park
Eastbourne, East Sussex
BN22 9AG UK
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
TEVA Santé SA
Rue Bellocier
89107 Sens
France
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A.AG TelTél 32 38.20.73.73 LuxembourgLuxemburg Teva Pharma Belgium N.V.S.A.AG TelTél 32 38.20.73.73
Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt., Tel 36 1 288 6400
eská republika Teva Pharmaceuticals CR, s.r.o Telephone 420 606 763 892 Malta Teva .. 30 210 72 79 099
Danmark Teva Denmark AS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400
Deutschland Teva GmbH Tel 49 351 834 0 Norge Teva Sweden AB Telephone 46 42 12 11 00
Österreich Teva GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filial Tel 372 611 2409
Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o Telephone 48 22 345 93 00
España Teva Pharma, S.L.U. Telephone 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos, Lda. Telephone 351 214 235 910
France Teva Santé Telephone 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Telephone 4021 230 65 24
Ireland Teva Pharmaceuticals Ireland Telephone 353 42 9395892. Slovenija Teva UK Limited Telephone 44 1323 501 111.
Ísland Teva UK Limited Telephone 44 1323 501 111. Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Telephone 421 2 5726 7911
Italia Teva Italia S.r.l. Telephone 39 0289179805 SuomiFinland Teva Sweden AB Telephone 46 42 12 11 00
Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Telephone 46 42 12 11 00
Latvija UAB Sicor Biotech Latvian Affiliate Telephone 371 67784980. United Kingdom Teva UK Limited Telephone 44 1323 501 111.
Lietuva
UAB ?Sicor Biotech?
Telephone: +370 5 266 02 03
This leaflet was last approved in {MM/YYYY}.