What Ovitrelle contains
The active substance is choriogonadotropin alfa, each vial contains 285 micrograms. After reconstitution 250 micrograms, which is the equivalent of 6500 IU, is delivered because some choriogonadotropin alfa will be left in the vial, in the syringe and in the needle.
The other ingredients are sucrose, phosphoric acid, and sodium hydroxide.
The solvent is water for injections.
What Ovitrelle looks like and contents of the pack
Ovitrelle is provided as a powder and solvent for solution for injection. It is available in packs containing 1, 2, or 10 vials of powder containing the active substance which are accompanied by the corresponding number of solvent containers. Not all pack sizes may be marketed.
Each vial of powder contains 285 micrograms of choriogonadotropin alfa and each container of solvent contains 1 ml of water for injections. When one vial is reconstituted with 1 ml of solvent you will receive a dose of 250 micrograms.
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
MERCK d.o.o. Dunajska cesta 119 SI 1000 , Te 386 1 560 3 800 Magyarország Merck Kft. Bocskai út 134-146. H-1113 Budapest Tel 36-1-463-8100
eská republika Merck spol.s.r.o Na Hrebenech II. 171810 CZ-140 00 Praha 4 Tel. 420 272084211 Malta Cherubino Ltd Delf Building Sliema Road MT-GZR 06 Gzira Malta Tel 356-21-3432701234
Danmark E. Merck AB 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 Serono GmbH Alsfelder Straße 17 D-64289 Darmstadt Tel 49-6151-6285-0 Norge Merck Serono Norge Luhrtoppen 2 1470 Lørenskog Tlf 47 67 90 35 90
Österreich Merck GesmbH. Zimbagasse 5 A-1147 Wien Tel 43 1 57600-0 Eesti Merck Serono Esindaja Co Ares Trading SA Baltic States Zamenhofo 11-3, LT-44287 Kaunas, Leedu Tel 370 37320603
Merck A.E. 41-45, GR-151 23 T 30-210-61 65 100 Polska Merck Sp. z o.o. Al. Jerozolimskie 178 02-486 Warszawa Polska Tel. 48 22 53 59 700
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
Slovenská republika Merck spol. s r.o. Tuhovská 3 SK-831 06 Bratislava Tel 421 2 49 267 111 Ísland Icepharma hf Lynghálsi 13 110 Reykjavík Íceland Tel 354 540 8000
Italia Merck Serono S.p.A. Via Casilina 125 I-00176 Roma Tel 39-06-70 38 41 SuomiFinland Merck Oy Pihatörmä 1 C FI-02240 Espoo PuhTel 358-9-8678 700
Sverige E. Merck AB S-195 87 Stockholm Tel 46-8-562 445 00 . . 35, 2234 , . 357 22490305
United Kingdom Merck Serono Ltd Bedfont Cross, Stanwell Road Feltham, Middlesex TW14 8NX Tel 44-20 8818 7200 Latvija Merck Serono Prstvniecba Co Ares Trading SA Baltic States Zamenhofo 11-3, LT-44287 Kaua, Lietuva Tel 370 37320603
Lietuva
Merck Serono Atstovyb-
C/o Ares Trading SA Baltic States
Zamenhofo 11-3,
LT-44287 Kaunas
Tel: +370 37320603
This leaflet was last approved on