What FABLYN contains
- The active substance is lasofoxifene. Each film-coated tablet contains lasofoxifene tartrate,equivalent to 500 micrograms of lasofoxifene.
- The other ingredients are lactose anhydrous; microcrystalline cellulose; croscarmellose sodium;silica, colloidal anhydrous; magnesium stearate; sunset yellow FCF aluminium lake (E110);hypromellose; lactose monohydrate; titanium dioxide (E171) and triacetin.
What FABLYN looks like and contents of the pack
FABLYN tablets are triangular, peach coloured, film-coated tablets marked with ?Pfizer? on one sideand ?OPR 05? on the other.
The tablets are provided in blister packs containing 7, 28 or 30 tablets, and in bottle packs containing90 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ,United Kingdom.
The Manufacturer is Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, 89257Illertissen, Germany.
For any information about this medicine, please contact the local representative of the MarketingAuthorisation Holder:
BelgiëBelgiqueBelgienPfizer S.A.N.V.TélTel 32 02 554 62 11 , . 359 2 970 4333eská republikaPfizer s.r.o.Tel 420-283-004-111DanmarkPfizer ApSTlf 45 44 20 11 00DeutschlandPfizer Pharma GmbHTel 49 0 30 55 0055-51000EestiPfizer Luxembourg SARL Eesti filiaalTel 372 6 405 328Pfizer Hellas A.E. 30 210 6785 800EspañaPfizer S.A.Tel 34 91 490 99 00France LuxembourgLuxemburgPfizer S.A.Tél 32 02 554 62 11MagyarországPfizer Kft.Tel. 36 1 488 37 00MaltaV.J. Salomone Pharma Ltd.Tel 356 21 22 01 74NederlandPfizer bvTel 31 010 406 43 01NorgePfizer ASTlf 47 67 52 61 00ÖsterreichPfizer Corporation Austria Ges.m.b.H.Tel 43 01 521 15-0PolskaPfizer Polska Sp. z o.o.Tel. 48 22 335 61 00PortugalLaboratórios Pfizer, Lda.Tel 351 214 235 500Români
PfizerTél 33 01 58 07 34 40IrelandPfizer Healthcare IrelandTel 1800 633 363Pfizer România S.R.LTel 40 021 207 28 00SlovenijaPfizer Luxembourg SARLPfizer, podrunica za svetovanje s podrojafarmacevtske dejavnosti, LjubljanaTel 386 01 52 11 400Slovenská republikaPfizer Luxembourg SARL, organizaná zlokaTel 421-2-3355 5500SuomiFinlandPfizer OyPuhTel 35809 43 00 40SverigePfizer ABTel 46 08 5505 2000United KingdomPfizer LimitedTel 44 01737 331111ÍslandVistor hf.,Sími 354 535 7000ItaliaPfizer Italia S.r.l.Tel 39 06 33 18 21GEO. PAVLIDES ARAOUZOS LTD, 35722818087LatvijaPfizer Luxembourg SARLFilile LatvijTel 371 670 35 775LietuvaPfizer Luxembourg SARLfilialas LietuvojeTel. 3705 251400
This leaflet was last approved in {MM/YYYY}.