What Luveris contains
The active substance is lutropin alfa .
Lutropin alfa is recombinant human luteinising hormone, r-hLH, produced by recombinant DNA technology. \
Each cartridge of Luveris contains 450 IU of lutropin alfa in 0.72 ml water for injections that allows delivering six doses of 75 IU of lutropin alfa.
The other ingredients are L-arginine HCl, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, phosphoric acid, polysorbate 20, L-methionine, phenol and water for injections.
What Luveris looks like and contents of the pack
Luveris 450 IU/0.72 ml is presented as a solution for injection in a cartridge.
It is supplied in packs of 1 cartridge containing 6 doses.
An appropriate autoinjector device is supplied separately.
The solution is clear and colourless.
Marketing Authorisation Holder
Merck Serono Europe Limited
56 Marsh Wall
London E14 9TP
United Kingdom
Manufacturer
Merck Serono S.p.A.
Via delle Magnolie 15
I-70026 Modugno (Bari)
Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
BelgiëBelgiqueBelgien MERCK NVSA Brusselsesteenweg 288 B-3090 Overijse TélTel 32-2-686 07 11 LuxembourgLuxemburg MERCK NVSA Brusselsesteenweg 288 B-3090 Overijse, BelgiqueBelgien TélTel 32-2-686 07 11
Magyarország Merck Kft. Bocskai út 134-146. H-1113 Budapest Tel 36-1-463-8100 . . 83 1582 Te 359 28075 111
eská republika Merck spol. s r.o. Na Hrebenech II. 171810 CZ-140 00 Praha 4 Tel. 420 272084 211 Malta Cherubino Ltd Delf Building Sliema Road MT-GZR 06 Gzira Malta Tel 356-21-3432701234
Danmark Merck AS Strandvejen 102 B, 4th DK-2900 Hellerup Tlf 45 35253550 Nederland Merck BV Tupolevlaan 41-61 NL-1119 NW Schiphol-Rijk Tel 31-20-6582800
Deutschland Merck Serono GmbH Alsfelder Straße 17 D-64289 Darmstadt Tel 49-6151-6285-0 Norge Merck Serono Norge Luhrtoppen 2 N-1470 Lørenskog Tlf 47 67 90 35 90
Eesti Merck Serono OÜ Tornimäe 7 - 132 EE-10145, Tallinn Tel 372 682 5882 Österreich Merck GesmbH. Zimbagasse 5 A-1147 Wien Tel 43 1 57600-0
Polska Merck Sp. z o.o. Al. Jerozolimskie 178 PL-02-486 Warszawa Tel. 48 22 53 59 700 Merck A.E. 41-45, GR-151 23 T 30-210-61 65 100
Portugal Merck, s.a. Rua Alfredo da Silva, 3-C P-1300-040 Lisboa Tel 351-21-361 35 00 España Merck S.L. María de Molina, 40 E-28006 Madrid Línea de Información 900 200 400 Tel 34-91-745 44 00
România MERCK d.o.o., Dunajska cesta 119 SI-1000 Lubliana, Slovenia Tel 386 1 560 3 800 France Merck Serono s.a.s. 37, rue Saint-Romain F-69379 Lyon cedex 08 Tél. 33-4-72 78 25 25 Numéro vert 0 800 888 024
Slovenija MERCK d.o.o. Dunajska cesta 119 SI-1000 Ljubljana Tel 386 1 560 3 800 Ireland Merck Serono Ltd Bedfont Cross, Stanwell Road Feltham, Middlesex TW14 8NX United Kingdom Tel 44-20 8818 7200
Ísland Icepharma hf Lynghálsi 13 IS-110 Reykjavík Tel 354 540 8000 Slovenská republika Merck spol. s r.o. Tuhovská 3 SK-831 06 Bratislava Tel 421 2 49 267 111
Italia Merck Serono S.p.A. Via Casilina 125 I-00176 Roma Tel 39-06-70 38 41 SuomiFinland Merck Oy Pihatörmä 1 C FIN-02240 Espoo PuhTel 358-9-8678 700
. . ef 35, CY-2234 ats, 357-22-490305 Sverige Merck AB Box 3033 169 03 Solna Tel 46-8-562 445 00
Latvija Merck Serono SIA Duntes iela 23A LV-1005, Rga Tel 371 67152500 United Kingdom Merck Serono Ltd Bedfont Cross, Stanwell Road Feltham, Middlesex TW14 8NX UK Tel 44-20 8818 7200
Lietuva
Merck Serono UAB
Savanoriu pr. 192,
LT-44151 Kaunas
Tel: +370 37320603
This leaflet was last approved in
Filename EU SPC LAB PL Lutropin 2011Feb11sub II-45 Rto2ndRSI en.doc Directory FxmadridWork05DptTSAndres919060ToFQA00 SourceUpdated source H04EN v4.0.dot Luveris, INN-lutropin alfa EPAR CHMP Luveris, INN-lutropin alfa Template Title Subject Author Keywords Comments Creation Date Change Number Last Saved On Last Saved By Total Editing Time Last Printed On 3142011 124100 PM 4 3142011 124200 PM II-45 Day5 2 Minutes 3142011 124200 PM As of Last Complete Printing Number of Pages 54 Number of Words 14.943 approx. Number of Characters 85.177 approx.