List of nationally authorised medicinal products

Transkripts

1 19 September 2019 EMA/590274/2019 Human Medicines Evaluation Division Active substance: botulinum toxin a - haemagglutinin complex Procedure no.: PSUSA/ / Official address Domenico Scarlattilaan HS Amsterdam The Netherlands Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0) An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 National Number Azzalure 10 Speywood jednotiek/0,05 ml prášok na injekčný roztok Azzalure 125 Speywood egység por oldatos injekcióhoz Azzalure 125 Speywood egység por oldatos injekcióhoz Azzalure 125 Speywood jednotek prášek pro injekční roztok Azzalure 125 Speywood- Einheiten, Pulver zur Herstellung einer Injektionslösung Azzalure 125 Speywood- Einheiten, Pulver zur Herstellung einer Injektionslösung Azzalure, 10 Speywoodeenheden/0,05ml, poeder voor oplossing voor injectie Azzalure, 10 unidades Speywood/0,05 ml, polvo para solución inyectable Azzalure, 10 μονάδες Speywood / 0,05 ml, κόνις για ενέσιμο διάλυμα. FR/H/0341/001 63/0115/10-S IPSEN BIOPHARM LTD SK FR/H/0341/001 OGYI-T-21618/01 IPSEN PHARMA HU FR/H/0341/001 OGYI-T-21618/02 IPSEN PHARMA HU FR/H/0341/001 63/120/10-C IPSEN PHARMA CZ FR/H/0341/ IPSEN PHARMA AT FR/H/0341/ IPSEN PHARMA DE FR/H/0341/001 RVG IPSEN PHARMA NL FR/H/0341/ IPSEN PHARMA SA ES FR/H/0341/ IPSEN PHARMA GR EMA/590274/2019 Page 2/9

3 National Number Azzalure, 125 jednostek Speywood, proszek do sporządzania roztworu do wstrzykiwań Azzalure, 125 Speywood einingar, stungulyfsstofn, lausn Azzalure, 125 Speywood units, powder for solution for injection Azzalure, 125 Speywood units, powder for solution for injection Azzalure, 125 Speywoodeenheden, poeder voor oplossing voor injectie Azzalure, 125 Speywood- Einheiten, Pulver zur Herstellung einer Injektionslösung Azzalure, 125 Speywoodenheter, pulver til injeksjonsvæske, oppløsning Azzalure, 125 Speywoodenheter, pulver till Azzalure, 125 Speywoodyksikköä, injektiokuivaaine liuosta varten Azzalure, 125 unidades Speywood, pó para solução injetável FR/H/0341/ IPSEN PHARMA PL FR/H/0341/001 IS/1/09/023/01 INSTITUT PRODUITS FR/H/0341/001 PA 1613/001/001 IPSEN PHARMA IE FR/H/0341/001 PL 06958/0031 IPSEN LTD UK FR/H/0341/001 BE IPSEN PHARMA BE FR/H/0341/001 BE IPSEN PHARMA BE FR/H/0341/ INSTITUT PRODUITS FR/H/0341/ INSTITUT PRODUITS FR/H/0341/ INSTITUT PRODUITS FR/H/0341/ IPSEN PHARMA PT Azzalure, 125 unidades FR/H/0341/ IPSEN PHARMA PT IS NO EMA/590274/2019 Page 3/9

4 National Number Speywood, pó para solução injetável Azzalure, 125 unità Speywood, polvere per soluzione iniettabile. Azzalure, 125 unità Speywood, polvere per soluzione iniettabile. Azzalure, 125 unités Speywood, poudre pour AZZALURE, 125 unités Speywood, poudre pour AZZALURE, 125 unités Speywood, poudre pour Azzalure, 125 unités Speywood, poudre pour Azzalure, 125 μονάδες Speywood, κόνις για ενέσιμο διάλυμα. Azzalure, pulver til injektionsvæske opløsning Azzalure125 Speywoodenheter, pulver till Botulinum Toxin Type A 300 units Powder for solution for injection Botulinum Toxin Type A 500 units Powder for FR/H/0341/ IPSEN S.P.A. IT FR/H/0341/ IPSEN S.P.A. IT FR/H/0341/001 BE IPSEN PHARMA BE FR/H/0341/ IPSEN PHARMA FR FR/H/0341/ IPSEN PHARMA FR FR/H/0341/ / IPSEN PHARMA LU FR/H/0341/ IPSEN PHARMA CY FR/H/0341/ INSTITUT PRODUITS FR/H/0341/ INSTITUT PRODUITS not available PL 34926/0015 IPSEN LTD UK not available PL 34926/0009 IPSEN LTD UK DK SE EMA/590274/2019 Page 4/9

5 National Number solution for injection Dysline, 300 U/VIAL, not available IPSEN E.P.E. GR κόνις για ενέσιμο διάλυμα Dysport 500 U/VIAL not available IPSEN E.P.E. CY Dysport 500 U/VIAL not available /11/2016 IPSEN E.P.E. GR Dysport 300 E por not available OGYI-T-8419/03 IPSEN PHARMA HU oldatos injekcióhoz Dysport 300 E por not available OGYI-T-8419/04 IPSEN PHARMA HU oldatos injekcióhoz Dysport 300 E, poeder voor oplossing voor injectie not available RVG IPSEN FARMACEUTICA B.V. NL Dysport 300 enheter (E), pulver till DYSPORT 300 Speywood jednotek prášek pro injekční roztok Dysport 300 U injektiokuiva-aine, liuosta varten Dysport 300 U prášok na injekčný roztok DYSPORT 300 UNITES SPEYWOOD, poudre pour Dysport 300 units Powder for solution for injection Dysport 300 V Milteliai injekciniam tirpalui Dysport 300 V Milteliai injekciniam tirpalui not available INSTITUT PRODUITS not available 63/335/12-C IPSEN PHARMA CZ not available INSTITUT PRODUITS not available 63/0188/14-S IPSEN PHARMA SK not available IPSEN PHARMA FR not available PL 34926/0014 IPSEN LTD UK not available LT/1/99/0312/003 IPSEN PHARMA LT not available LT/1/99/0312/004 IPSEN PHARMA LT SE EMA/590274/2019 Page 5/9

6 National Number Dysport 300 V pulveris injekciju šķīduma pagatavošanai Toxinum A Clostridii botulini haemagglutininum multiplex Dysport 500 E por oldatos injekcióhoz Dysport 500 E por oldatos injekcióhoz DYSPORT 500 E pulver til injeksjonsvæske, oppløsning Dysport 500 E, poeder voor oplossing voor injectie Dysport 500 E, pulver till Dysport 500 E, Pulver zur Herstellung einer Injektionslösung DYSPORT 500 enot prašek za raztopino za injiciranje DYSPORT 500 enot prašek za raztopino za injiciranje DYSPORT 500 Speywood jednotek prášek pro injekční roztok Dysport 500 U injektiokuiva-aine, liuosta varten not available IPSEN PHARMA LV not available OGYI-T-8419/02 IPSEN PHARMA HU not available OGYI-T-8419/01 IPSEN PHARMA HU SE/H/0283/ INSTITUT PRODUITS not available BE IPSEN N.V. BE SE/H/0283/ INSTITUT PRODUITS SE not available BE IPSEN N.V. BE not available H/02/00520/002 IPSEN PHARMA SI not available H/02/00520/001 IPSEN PHARMA SI not available 63/060/91-S/C IPSEN PHARMA CZ not available INSTITUT PRODUITS DYSPORT 500 U pó para not available IPSEN PORTUGAL PT NO EMA/590274/2019 Page 6/9

7 National Number solução injetável DYSPORT 500 U pó para solução injetável DYSPORT 500 U POLVO PARA SOLUCIÓN INYECTABLE Dysport 500 U prášok na injekčný roztok Dysport 500 U, poudre pour Dysport 500 U, poudre pour DYSPORT 500 unità Polvere per soluzione iniettabile per uso intramuscolare e sottocutaneo Tossina botulinica tipo A da C. botulinum complesso - emoagglutinina DYSPORT 500 unitati pulbere pentru solutie injectabila DYSPORT 500 UNITES SPEYWOOD, poudre pour Dysport 500 units Powder for solution for injection Dysport 500 V milteliai injekciniam tirpalui PRODUTOS FARMACÊUTICOS, S.A. not available IPSEN PORTUGAL PT PRODUTOS FARMACÊUTICOS, S.A. not available IPSEN PHARMA SA ES not available 63/0060/91-S IPSEN PHARMA SK not available BE IPSEN N.V. BE not available IPSEN N.V. LU not available IPSEN S.P.A. IT not available 10661/2018/01 IPSEN PHARMA RO not available IPSEN PHARMA FR not available PL 34926/0001 IPSEN LTD UK not available LT/1/99/0312/002 IPSEN PHARMA LT EMA/590274/2019 Page 7/9

8 National Number Dysport 500 V milteliai injekciniam tirpalui Dysport 500 V pulveris injekciju šķīduma pagatavošanai Toxinum A Clostridii botulini haemagglutininum multiplex Dysport pulver til injektionsvæske opløsning 300 enheder Dysport pulver til injektionsvæske opløsning 500 enheder Dysport 500 units Powder for solution for injection Dysport, 300 j. kompleksu neurotoksyny Clostridium botulinum typu A/fiolkę proszek do sporządzania roztworu do wstrzykiwań DYSPORT, 300 Ü süstelahuse pulber Dysport, 500 j. kompleksu neurotoksyny Clostridium botulinum typu A/fiolkę proszek do sporządzania roztworu do wstrzykiwań DYSPORT, 500Ü süstelahuse pulber not available LT/1/99/0312/001 IPSEN PHARMA LT not available IPSEN PHARMA LV not available INSTITUT PRODUITS not available INSTITUT PRODUITS not available PA 1613/002/001 IPSEN PHARMA IE not available IPSEN PHARMA PL not available IPSEN PHARMA EE not available R/7292 IPSEN PHARMA PL not available IPSEN PHARMA EE DK DK EMA/590274/2019 Page 8/9

9 National Number Dysport, poeder voor injectievloeistof 500 E Dysport, poeder voor injectievloeistof 500 E Dysport 300 Einheiten Pulver zur Herstellung einer Injektionslösung Dysport 500 Einheiten Pulver zur Herstellung einer Injektionslösung Dysport 500 Einheiten, Pulver zur Herstellung einer Injektionslösung Dysport Pulver till 300 U Dysport Pulver till 500 U Диспорт 300 U прах за инжекционен разтвор Диспорт 500 U прах за инжекционен разтвор, not available RVG IPSEN FARMACEUTICA B.V. NL not available RVG IPSEN FARMACEUTICA B.V. NL not available IPSEN PHARMA GMBH DE not available IPSEN PHARMA GMBH DE not available IPSEN PHARMA GMBH AT not available INSTITUT PRODUITS not available INSTITUT PRODUITS not available IPSEN PHARMA BG not available IPSEN PHARMA BG EMA/590274/2019 Page 9/9