30 November 2017 EMA/803254/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: triptorelin
Procedure no.: PSUSA/00003048/201703
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country) Decapeptyl Depot Retardmikrokapseln und Suspensionsmittel in Einmalspritzen Decapeptyl 0,1 mg Fertigspritzen Salvacyl® 11,25 mg Pulver und Lösungsmittel zur Herstellung einer DepotInjektionssuspension Pamorelin® LA 3,75 mg Pulver und Lösungsmittel zur Herstellung einer DepotInjektionssuspension Pamorelin® LA 22,5 mg Pulver und Lösungsmittel zur Herstellung einer DepotInjektionssuspension Pamorelin® LA 11,25 mg Pulver und Lösungsmittel zur Herstellung einer DepotInjektionssuspension Decapeptyl Depot Retardmikrokapseln und Suspensionsmittel in Einmalspritzen Decapeptyl 0,1 mg Fertigspritzen Gonapeptyl Depot 3,75 mg poudre et solvant pour suspension injectable
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
1-18914
FERRING ARZNEIMITTEL GES.M.B.H.
AT
not available
1-22758
AT
SE/H/0663/001
136649
FERRING ARZNEIMITTEL GES.M.B.H. IPSEN PHARMA GMBH
DE/H/0566/001
1-26714
IPSEN PHARMA GMBH
AT
DE/H/0492/002
1-29049
IPSEN PHARMA GMBH
AT
DE/H/0492/001
1-25892
IPSEN PHARMA GMBH
AT
not available
1-18914
FERRING ARZNEIMITTEL GES.M.B.H.
AT
not available
1-22758
AT
NL/H/0263/001
BE230027
FERRING ARZNEIMITTEL GES.M.B.H. FERRING N.V.
List of nationally authorised medicinal products
AT
BE
Page 2/26
Product Name (in authorisation country) Gonapeptyl Depot 3,75 mg poeder en oplosmiddel voor suspensie voor injectie Gonapeptyl Daily 0,1 mg/1 ml, solution injectable Gonapeptyl Daily 0,1 mg/1 ml, oplossing voor injectie Decapeptyl Sustained Release 11,25 mg Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension Decapeptyl Sustained Release 3,75 mg Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension Decapeptyl Sustained Release 22,5 mg, Pulver und Lösungsmittel zur Herstellung einer DepotInjektionssuspension Salvacyl 11,25 mg Pulver und Lösungsmittel zur Herstellung einer DepotInjektionssuspension Decapeptyl 0,1 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Decapeptyl 0,1 mg poudre et solvant pour solution injectable
MRP/DCP Authorisation number NL/H/0263/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BE230027
FERRING N.V.
BE
NL/H/1427/001
BE339902
FERRING N.V.
BE
NL/H/1427/001
BE 339902
FERRING N.V.
BE
not available
BE 192516
IPSEN N.V.
BE
not available
BE 145826
IPSEN N.V.
BE
DE/H/0492/002
BE 362284
IPSEN N.V.
BE
SE/H/0663/001
BE 310484
IPSEN N.V.
BE
not available
BE 182454
IPSEN N.V.
BE
not available
BE 182454
IPSEN N.V.
BE
List of nationally authorised medicinal products EMA/173192/2017
Page 3/26
Product Name (in authorisation country) Decapeptyl 0,1 mg poeder en oplosmiddel voor oplossing voor injectie Decapeptyl Sustained Release 22,5 mg poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte Decapeptyl Sustained Release 22,5 mg poudre et solvant pour suspension injectable à libération prolongée Salvacyl 11,25 mg poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte Salvacyl 11,25 mg poudre et solvant pour suspension injectable à libération prolongée Gonapeptyl Daily 0,1 mg/1 ml, solution injectable Gonapeptyl Daily 0,1 mg/1 ml, oplossing voor injectie Gonapeptyl Depot 3,75 mg poudre et solvant pour suspension injectable Gonapeptyl Depot 3,75 mg poeder en oplosmiddel voor suspensie voor injectie
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BE 182454
IPSEN N.V.
BE
DE/H/0492/002
BE362284
IPSEN N.V.
BE
DE/H/0492/002
BE 362284
IPSEN N.V.
BE
SE/H/0663/001
BE310484
IPSEN N.V.
BE
SE/H/0663/001
BE310484
IPSEN N.V.
BE
NL/H/1427/001
BE339902
FERRING N.V.
BE
NL/H/1427/001
BE 339902
FERRING N.V.
BE
NL/H/0263/001
BE230027
FERRING N.V.
BE
NL/H/0263/001
BE230027
FERRING N.V.
BE
List of nationally authorised medicinal products EMA/173192/2017
Page 4/26
Product Name (in authorisation country) Decapeptyl Sustained Release 3,75 mg poudre et solvant pour suspension injectable Decapeptyl Sustained Release 3,75 mg poeder en oplosmiddel voor suspensie voor injectie Decapeptyl Sustained Release 11,25 mg poudre et solvant pour suspension injectable Decapeptyl Sustained Release 11,25 mg poeder en oplosmiddel voor suspensie voor injectie ДЕКАПЕПТИЛ ДЕПО 3,75 mg прах и разтворител за суспензия за инжекция ДЕКАПЕПТИЛ 0,1 mg/ml инжекционен разтвор ДИФЕРЕЛИН S.R. 11,25 mg прах и разтворител за инжекционна суспензия с удължено освобождаване ДИФЕРЕЛИН 0,1 mg прах и разтворител за инжекционен разтвор ДЕКАПЕПТИЛ 0,1 mg/ml инжекционен разтвор ДЕКАПЕПТИЛ ДЕПО 3,75 mg прах и разтворител за суспензия за инжекция
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BE145826
IPSEN N.V.
BE
not available
BE 145826
IPSEN N.V.
BE
not available
BE 192516
IPSEN N.V.
BE
not available
BE 192516
IPSEN N.V.
BE
not available
20000712
FERRING GMBH
BG
not available
20000284
FERRING GMBH
BG
not available
20040234
IPSEN PHARMA
BG
not available
20011172
IPSEN PHARMA
BG
not available
20000284
FERRING GMBH
BG
not available
20000712
FERRING GMBH
BG
List of nationally authorised medicinal products EMA/173192/2017
Page 5/26
Product Name (in authorisation country)
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
20011173
IPSEN PHARMA
BG
not available
17054
IPSEN E.P.E.
CY
not available
17055
IPSEN E.P.E.
CY
Arvekap 11,25 mg/vial (3 μηνών) DECAPEPTYL Depot 3,75 mg/ml prášek a rozpouštedlo pro injekcní suspenzi s prodlouženým uvolnováním DECAPEPTYL 0,1 mg
not available
19629
IPSEN E.P.E.
CY
not available
56/162/88-C/C
FERRING PHARMACEUTICALS CZ S.R.O.
CZ
not available
56/162/88 - A/C
CZ
DIPHERELINE 0,1 mg prášek a rozpouštědlo pro injekční roztok DIPHERELINE S.R. 22,5 mg, prášek a rozpouštědlo pro injekční suspenzi s prodlouženým účinkem DECAPEPTYL 0,1 mg
not available
56/182/01-C
FERRING PHARMACEUTICALS CZ S.R.O. IPSEN PHARMA
DE/H/0492/002
56/134/11-C
IPSEN PHARMA
CZ
not available
56/162/88 - A/C
CZ
DECAPEPTYL Depot 3,75 mg/ml prášek a rozpouštedlo pro injekcní suspenzi s prodlouženým uvolnováním
not available
56/162/88-C/C
FERRING PHARMACEUTICALS CZ S.R.O. FERRING PHARMACEUTICALS CZ S.R.O.
ДИФЕРЕЛИН S.R. 3,75 mg прах и разтворител за инжекционна суспензия с удължено освобождаване ARVEKAP 0.1 mg, powder and solvent for solution for injection (S.C.) Arvekap 3,75mg ®
List of nationally authorised medicinal products EMA/173192/2017
CZ
CZ
Page 6/26
Product Name (in authorisation country) DIPHERELINE S.R. 3 mg prášek a rozpouštědlo pro injekční suspenzi s prodlouženým účinkem DIPHERELINE S.R. 11,25 mg prášek a rozpouštědlo pro injekční suspenzi s prodlouženým uvolňováním DECAPEPTYL 0,1 mg DECAPEPTYL® N 3,75 mg Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension DECAPEPTYL® IVF 0,1 mg/1 ml Injektionslösung DECAPEPTYL Gyn 3,75 mg Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension Pamorelin® LA 3,75 mg Pulver und Lösungsmittel zur Herstellung einer DepotInjektionssuspension Salvacyl® 11,25 mg Pulver und Lösungsmittel zur Herstellung einer DepotInjektionssuspension DECAPEPTYL 0,1 mg
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
56/214/01-C
IPSEN PHARMA
CZ
not available
56/009/03-C
IPSEN PHARMA
CZ
not available
6411.01.00
FERRING GMBH
DE
NL/H/0263/001
51973.00.00
FERRING GMBH
DE
NL/H/1427/001
80353.00.00
DE
not available
28679.00.00
FERRING ARZNEIMITTEL GMBH FERRING GMBH
DE/H/0566/001
59220.00.00
IPSEN PHARMA GMBH
DE
SE/H/0663/001
67875.00.00
IPSEN PHARMA GMBH
DE
not available
6411.01.00
FERRING GMBH
DE
List of nationally authorised medicinal products EMA/173192/2017
DE
Page 7/26
Product Name (in authorisation country) DECAPEPTYL Gyn 3,75 mg Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension DECAPEPTYL® IVF 0,1 mg/1 ml Injektionslösung DECAPEPTYL® N 3,75 mg Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension Pamorelin® LA 11,25 mg Pulver und Lösungsmittel zur Herstellung einer DepotInjektionssuspension Pamorelin® LA 22,5 mg Pulver und Lösungsmittel zur Herstellung einer DepotInjektionssuspension Decapeptyl Depot, pulver og solvens til injektionsvæske, suspension Gonapeptyl, injektionsvæske, opløsning Pamorelin, depotinjektionsvæske, pulver og solvens til suspension, 22,5 mg Salvacyl, pulver og solvens til depotinjektionsvæske, suspension
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
28679.00.00
FERRING GMBH
DE
NL/H/1427/001
80353.00.00
DE
NL/H/0263/001
51973.00.00
FERRING ARZNEIMITTEL GMBH FERRING GMBH
DE/H/492/001
55394.00.00
SODIA
DE
DE/H/0492/002
73771.00.00
SODIA
DE
not available
13788
FERRING LÆGEMIDLER A/S
DK
NL/H/1427/001
46157
FERRING LÆGEMIDLER A/S
DK
DE/H/0492/002
44037
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
DK
SE/H/0663/001
40364
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
DK
List of nationally authorised medicinal products EMA/173192/2017
DE
Page 8/26
Product Name (in authorisation country) Pamorelin, depotinjektionsvæske, pulver og solvens til suspension, 11,25 mg Pamorelin, depotinjektionsvæske, pulver og solvens til suspension, 3,75 mg Decapeptyl Depot, pulver og solvens til injektionsvæske, suspension Gonapeptyl, injektionsvæske, opløsning Diphereline 0,1 mg süstelahuse pulber ja lahusti Diphereline 3,75 mg, toimeainet prolongeeritult vabastava süstesuspensiooni pulber ja lahusti Diphereline 11,25 mg, toimeainet prolongeeritult vabastava süstesuspensiooni pulber ja lahusti GONAPEPTYL DEPOT 3,75 mg Polvo y disolvente para suspensión inyectable GONAPEPTYL Diario 0,1 mg/ml solución inyectable
MRP/DCP Authorisation number DE/H/0492/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
36798
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
DK
DE/H/0566/001
39195
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
DK
not available
13788
FERRING LÆGEMIDLER A/S
DK
NL/H/1427/001
46157
FERRING LÆGEMIDLER A/S
DK
not available
384602
IPSEN PHARMA
EE
not available
279299
IPSEN PHARMA
EE
not available
698410
IPSEN PHARMA
EE
NL/H/0263/001
64.530
FERRING S.A.U.
ES
NL/H/1427/001
71.060
FERRING S.A.U.
ES
List of nationally authorised medicinal products EMA/173192/2017
Page 9/26
Product Name (in authorisation country) Decapeptyl semestral 22,5 mg polvo y disolvente para suspensión de liberación prolongada inyectable Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable Decapeptyl trimestral 11,25 mg polvo y disolvente para suspensión de liberación prolongada inyectable GONAPEPTYL Diario 0,1 mg/ml solución inyectable GONAPEPTYL DEPOT 3,75 mg Polvo y disolvente para suspensión inyectable Decapeptyl mensual 3,75 mg polvo y disolvente para suspensión de liberación prolongada inyectable DECAPEPTYL DEPOT 3,75 mg injektiokuiva-aine ja liuotin, suspensiota varten Decapeptyl Depot 3,75 mg pulver och vätska till injektionsvätska, suspension Gonapeptyl 0,1 mg/ml injektioneste, liuos Gonapeptyl 0,1 mg/ml injektionsvätska, lösning
MRP/DCP Authorisation number DE/H/0492/002
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
72077
IPSEN PHARMA SA
ES
not available
62.431
IPSEN PHARMA SA
ES
not available
61.665
IPSEN PHARMA SA
ES
NL/H/1427/001
71.060
FERRING S.A.U.
ES
NL/H/0263/001
64.530
FERRING S.A.U.
ES
not available
58.404
IPSEN PHARMA SA
ES
not available
10585
FERRING LÄÄKKEET OY
FI
not available
10585
FERRING LÄÄKKEET OY
FI
NL/H/1427/001
28222
FERRING LÄÄKKEET OY
FI
NL/H/1427/001
28222
FERRING LÄÄKKEET OY
FI
List of nationally authorised medicinal products EMA/173192/2017
Page 10/26
Product Name (in authorisation country) Pamorelin 11,25 mg injektiokuiva-aine ja liuotin, depotsuspensiota varten Pamorelin 22,5 mg injektiokuiva-aine ja liuotin, depotsuspensiota varten Pamorelin 3,75 mg injektiokuiva-aine ja liuotin depotsuspensiota varten Salvacyl 11,25 mg injektiokuiva-aine ja liuotin, depotsuspensiota varten DECAPEPTYL DEPOT 3,75 mg injektiokuiva-aine ja liuotin, suspensiota varten Gonapeptyl 0,1 mg/ml injektioneste, liuos Gonapeptyl 0,1 mg/ml injektionsvätska, lösning Decapeptyl Depot 3,75 mg pulver och vätska till injektionsvätska, suspension Pamorelin 22,5 mg pulver och vätska till injektionsvätska, depotsuspension Salvacyl 11,25 mg pulver och vätska till injektionsvätska, depotsuspension
MRP/DCP Authorisation number DE/H/0492/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
19626
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
FI
DE/H/0492/002
25532
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
FI
DE/H/0566/001
22062
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
FI
SE/H/0663/001
22912
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
FI
not available
10585
FERRING LÄÄKKEET OY
FI
NL/H/1427/001
28222
FERRING LÄÄKKEET OY
FI
NL/H/1427/001
28222
FERRING LÄÄKKEET OY
FI
not available
10585
FERRING LÄÄKKEET OY
FI
DE/H/0492/002
25532
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
FI
SE/H/0663/001
22912
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
FI
List of nationally authorised medicinal products EMA/173192/2017
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Product Name (in authorisation country) GONAPEPTYL 3,75 mg, poudre et solvant pour suspension injectable à libération prolongée en seringues pré-remplies. GONAPEPTYL 3,75 mg, poudre et solvant pour suspension injectable à libération prolongée en seringues pré-remplies GONAPEPTYL 3,75 mg, poudre et solvant pour suspension injectable à libération prolongée en seringues pré-remplies. GONAPEPTYL 3,75 mg, poudre et solvant pour suspension injectable à libération prolongée en seringues pré-remplies DECAPEPTYL 0,1 mg poudre et solvant pour solution injectable (S.C.) DECAPEPTYL LP 22,5 mg poudre et solvant pour suspension injectable à libération prolongée DECAPEPTYL L.P. 11,25 mg, poudre et solvant pour suspension injectable (IM ou SC) forme à libération prolongée sur 3 mois DECAPEPTYL 0,1 mg poudre et solvant pour solution injectable (S.C.)
MRP/DCP Authorisation number NL/H/0263/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
3584467
FERRING S.A.S.
FR
NL/H/0263/001
3584473
FERRING S.A.S.
FR
NL/H/0263/001
3584467
FERRING S.A.S.
FR
NL/H/0263/001
3584473
FERRING S.A.S.
FR
not available
328 503-2
IPSEN PHARMA
FR
DE/H/0492/002
34009 398 901 7 3
IPSEN PHARMA
FR
not available
34009 341 256 5 2
IPSEN PHARMA
FR
not available
328 502-6
IPSEN PHARMA
FR
List of nationally authorised medicinal products EMA/173192/2017
Page 12/26
Product Name (in authorisation country) SALVACYL L.P. 11,25 mg, poudre et solvant pour suspension injectable à libération prolongée DECAPEPTYL L.P. 3,75 mg, poudre et solvant pour suspension injectable (I.M.) forme à libération prolongée sur 28 jours DECAPEPTYL L.P. 3 mg, poudre et solvant pour suspension injectable (I.M.) forme à libération prolongée sur 28 jours GONAPEPTYL DEPOT 3,75 mg Κόνις και διαλύτης για ενέσιμο εναιώρημα. GONAPEPTYL Daily 0,1 mg/1 ml ενέσιμο διάλυμα GONAPEPTYL Daily 0,1 mg/1 ml ενέσιμο διάλυμα GONAPEPTYL DEPOT 3,75 mg Κόνις και διαλύτης για ενέσιμο εναιώρημα. Arvekap 3,75mg Arvekap 11,25 mg/vial (3 μηνών) Arvekap 22,5 mg κόνις και διαλύτης για ενέσιμο εναιώρημα παρατεταμένης αποδέσμευσης arvekap 0,1 mg/vial Eνέσιμο λυόφιλο
MRP/DCP Authorisation number SE/H/0663/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
34009 380 814 5 9
IPSEN PHARMA
FR
not available
34009 328 500 3 7
IPSEN PHARMA
FR
not available
34009 339 437 6 9
IPSEN PHARMA
FR
NL/H/0263/001
46878/10-7-2007
FERRING HELLAS MEPE
GR
NL/H/1427/001
26902/17-04-2015
FERRING HELLAS MEPE
GR
NL/H/1427/001
26902/17-04-2015
FERRING HELLAS MEPE
GR
NL/H/0263/001
46878/10-7-2007
FERRING HELLAS MEPE
GR
not available
65706/10 - 8/7/2011
IPSEN E.P.E.
GR
not available
65706/10-8/7/2011
IPSEN E.P.E.
GR
DE/H/0492/002
78923
IPSEN E.P.E.
GR
not available
55723/05-6/11/06
IPSEN E.P.E.
GR
List of nationally authorised medicinal products EMA/173192/2017
Page 13/26
Product Name (in authorisation country)
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
HR-H-750053749
FERRING GMBH
HR
not available
HR-H-441368305
FERRING GMBH
HR
not available
HR-H-441368305
FERRING GMBH
HR
not available
HR-H-750053749
FERRING GMBH
HR
NL/H/1427/001
OGYI-T-21047/01
HU
Decapeptyl Depot por és oldószer szuszpenziós injekcióhoz Diphereline 0,1 mg por és oldószer oldatos injekcióhoz Diphereline SR 22,5 mg por és oldószer retard szuszpenziós injekcióhoz DIPHERELINE SR 11,25 MG POR ÉS OLDÓSZER RETARD SZUSZPENZIÓS INJEKCIÓHOZ Decapeptyl Depot por és oldószer szuszpenziós injekcióhoz Gonapeptyl 0,1 mg/ml oldatos injekció
not available
OGYI-T-5310/01
not available
OGYI-T-8168/01
FERRING MAGYARORSZÁG GYÓGYSZERKERESKEDELMI KFT. FERRING MAGYARORSZÁG GYÓGYSZERKERESKEDELMI KFT. IPSEN PHARMA
DE/H/0492/002
OGYI-T-21912/01
IPSEN PHARMA
HU
not available
OGYI-T-9082/01
IPSEN PHARMA
HU
not available
OGYI-T-5310/01
HU
NL/H/1427/001
OGYI-T-21047/01
Diphereline SR 3,75 mg por és oldószer retard szuszpenziós injekcióhoz
not available
OGYI-T-8169/01
FERRING MAGYARORSZÁG GYÓGYSZERKERESKEDELMI KFT. FERRING MAGYARORSZÁG GYÓGYSZERKERESKEDELMI KFT. IPSEN PHARMA
Decapeptyl CR 3,75 mg Prašak i otapalo za suspenziju za injekciju Decapeptyl 0,1 mg/1 ml otopina za injekciju u napunjenoj štrcaljki Decapeptyl 0,1 mg/1 ml otopina za injekciju u napunjenoj štrcaljki Decapeptyl CR 3,75 mg Prašak i otapalo za suspenziju za injekciju Gonapeptyl 0,1 mg/ml oldatos injekció
List of nationally authorised medicinal products EMA/173192/2017
HU HU
HU HU
Page 14/26
Product Name (in authorisation country) Gonapeptyl Depot 3.75 mg Powder and solvent for suspension for injection Salvacyl, 11.25 mg powder and solvent for prolonged-release suspension for injection Decapeptyl 6-month 22.5mg Powder and solvent for prolongedrelease suspension for injection Decapeptyl SR, 3 mg powder and solvent for suspension for injection Gonapeptyl Depot 3.75 mg Powder and solvent for suspension for injection Decapeptyl 3-month, 11.25 mg powder and solvent for suspension for injection Decapeptyl Depot 3,75 mg stungulyfsstofn og leysir, dreifa. Decapeptyl Depot 3,75 mg stungulyfsstofn og leysir, dreifa. GONAPEPTYL Depot 3,75 mg Polvere e solvente per sospensione iniettabile
MRP/DCP Authorisation number NL/H/0263/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PA 1009/18/1
FERRING IRELAND LTD.
IE
SE/H/0663/001
PA 0869/008/001
IPSEN PHARMACEUTICALS LTD.
IE
not available
PA 869/3/3
IPSEN PHARMACEUTICALS LTD.
IE
not available
PA 869/003/001
IPSEN PHARMACEUTICALS LTD.
IE
NL/H/0263/001
PA 1009/18/1
FERRING IRELAND LTD.
IE
not available
PA 869/003/002
IPSEN PHARMACEUTICALS LTD.
IE
not available
920160
FERRING LÆGEMIDLER A/S
IS
not available
920160
FERRING LÆGEMIDLER A/S
IS
NL/H/0263/001
035562014
FERRING S.P.A.
IT
List of nationally authorised medicinal products EMA/173192/2017
Page 15/26
Product Name (in authorisation country) GONAPEPTYL Depot 3,75 mg Polvere e solvente per sospensione iniettabile Fertipeptil 0,1 mg/1 ml soluzione iniettabile Fertipeptil 0,1 mg/1 ml soluzione iniettabile DECAPEPTYL 22,5 mg / 2ml - Polvere e solvente per sospensione iniettabile a rilascio prolungato Decapeptyl 0,1 mg / ml Polvere e solvente per soluzione iniettabile Fertipeptil 0,1 mg/1 ml soluzione iniettabile Fertipeptil 0,1 mg/1 ml soluzione iniettabile GONAPEPTYL Depot 3,75 mg Polvere e solvente per sospensione iniettabile GONAPEPTYL Depot 3,75 mg Polvere e solvente per sospensione iniettabile DECAPEPTYL 3,75 mg / 2ml Polvere e solvente per sospensione iniettabile a rilascio prolungato
MRP/DCP Authorisation number NL/H0263/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
035562026
FERRING S.P.A.
IT
NL/H/1427/001
039404013
FERRING S.P.A.
IT
NL/H/1427/001
039404025
FERRING S.P.A.
IT
not available
026999060
IPSEN S.P.A.
IT
not available
026999045
IPSEN S.P.A.
IT
NL/H/1427/001
039404013
FERRING S.P.A.
IT
NL/H/1427/001
039404025
FERRING S.P.A.
IT
NL/H/0263/001
035562014
FERRING S.P.A.
IT
NL/H0263/001
035562026
FERRING S.P.A.
IT
not available
026999021
IPSEN S.P.A.
IT
List of nationally authorised medicinal products EMA/173192/2017
Page 16/26
Product Name (in authorisation country) DECAPEPTYL 11.25 mg / 2ml - Polvere e solvente per sospensione iniettabile a rilascio prolungato Decapeptyl Depot 3,75 mg milteliai ir tirpiklis injekcinei suspensijai Diphereline 11,25 mg milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai Diphereline 22,5 mg milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai Diphereline 0,1 mg milteliai ir tirpiklis injekciniam tirpalui Decapeptyl Depot 3,75 mg milteliai ir tirpiklis injekcinei suspensijai Diphereline 3,75 mg milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai Gonapeptyl Depot 3,75 mg poudre et solvant pour suspension injectable Gonapeptyl Daily 0,1 mg/1 ml, solution injectable Decapeptyl 0,1 mg poudre et solvant pour solution injectable
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
026999058
IPSEN S.P.A.
IT
not available
LT/1/97/0244/001
FERRING GMBH
LT
not available
LT/1/94/0517/002
IPSEN PHARMA
LT
not available
LT/1/94/0517/004
IPSEN PHARMA
LT
not available
LT/1/94/0517/003
IPSEN PHARMA
LT
not available
LT/1/97/0244/001
FERRING GMBH
LT
not available
LT/1/94/0517/001
IPSEN PHARMA
LT
NL/H/0263/001
2002020033
FERRING N.V.
LU
NL/H/1427/001
2009080048
FERRING N.V.
LU
not available
2000090052
IPSEN N.V.
LU
List of nationally authorised medicinal products EMA/173192/2017
Page 17/26
Product Name (in authorisation country) Decapeptyl Sustained Release 22,5 mg, poudre et solvant pour suspension injectable à libération prolongée Gonapeptyl Daily 0,1 mg/1 ml, solution injectable Gonapeptyl Depot 3,75 mg poudre et solvant pour suspension injectable Decapeptyl Sustained Release 3,75 mg poudre et solvant pour suspension injectable Decapeptyl Sustained Release 11,25 mg poudre et solvant pour suspension injectable DIPHERELINE 11,25 mg pulveris un šķīdinātājs ilgstošās darbības injekciju suspensijas pagatavošanai Diphereline 22,5 mg pulveris un ﾅ｡ﾄｷﾄｫ din ﾄ》ﾄ ）s ilgsto ﾅ｡ﾄ《 darb ﾄｫ bas injekciju suspensijas pagatavo ﾅ｡anai Diphereline 3,75 mg pulveris un šķīdinātājs ilgstošās darbības injekciju suspensijas pagatavošanai Gonapeptyl 0.1 mg/1 ml solution for injection
MRP/DCP Authorisation number DE/H/0492/002
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
0142/11010123
IPSEN N.V.
LU
NL/H/1427/001
2009080048
FERRING N.V.
LU
NL/H/0263/001
2002020033
FERRING N.V.
LU
not available
1996035542
IPSEN N.V.
LU
not available
2000060006
IPSEN N.V.
LU
not available
03-0240
IPSEN PHARMA
LV
DE/H/0492/002
11-0003
IPSEN PHARMA
LV
not available
98-0005
IPSEN PHARMA
LV
NL/H/1427/001
MA461/00601
FERRING S.P.A.
MT
List of nationally authorised medicinal products EMA/173192/2017
Page 18/26
Product Name (in authorisation country) Gonapeptyl 0.1 mg/1 ml solution for injection Decapeptyl, oplossing voor injectie 0,5 mg/ml Decapeptyl-CR 3,75 mg, poeder en oplosmiddel voor suspensie voor injectie Gonapeptyl Depot, poeder en oplosmiddel voor suspensie voor injectie 3,75 mg Gonapeptyl 0,1 mg/1 ml, oplossing voor injectie Decapeptyl, oplossing voor injectie 0,1 mg/ml Salvacyl 11,25 mg poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte Pamorelin 3,75 mg, poeder en oplosmiddel voor suspensie voor injectie, met verlengde afgifte Pamorelin 11,25 mg, poeder en oplosmiddel voor suspensie voor injectie, met verlengde afgifte Pamorelin 22,5 mg, poeder en oplosmiddel voor suspensie voor injectie, met verlengde afgifte
MRP/DCP Authorisation number NL/H/1427/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
MA461/00601
FERRING S.P.A.
MT
not available
RVG 11779
FERRING B.V.
NL
not available
RVG 12450
FERRING B.V.
NL
NL/H/0263/001
RVG 25383
FERRING B.V.
NL
NL/H/1427/001
RVG 33462
FERRING B.V.
NL
not available
RVG 11778
FERRING B.V.
NL
DE/H/0492/001
RVG 34737
IPSEN FARMACEUTICA B.V.
NL
DE/H/0566/001
RVG 33849
IPSEN FARMACEUTICA B.V.
NL
DE/H/0492/001
RVG 31138
IPSEN FARMACEUTICA B.V.
NL
DE/H/0492/002
RVG 103585
IPSEN FARMACEUTICA B.V.
NL
List of nationally authorised medicinal products EMA/173192/2017
Page 19/26
Product Name (in authorisation country) Decapeptyl-CR 3,75 mg, poeder en oplosmiddel voor suspensie voor injectie Decapeptyl, oplossing voor injectie 0,1 mg/ml Decapeptyl, oplossing voor injectie 0,5 mg/ml Gonapeptyl 0,1 mg/1 ml, oplossing voor injectie Gonapeptyl Depot, poeder en oplosmiddel voor suspensie voor injectie 3,75 mg Gonapeptyl 0,1 mg/ml injeksjonsvæske, oppløsning Salvapar 11,25 mg pulver og væske til depotinjeksjonsvæske, suspensjon Pamorelin 3,75 mg pulver og væske til depotinjeksjonsvæske, suspensjon Pamorelin 22,5 mg pulver og væske til depotinjeksjonsvæske, suspensjon Pamorelin 11,25 mg pulver og væske til depotinjeksjonsvæske, suspensjon Gonapeptyl 0,1 mg/ml injeksjonsvæske, oppløsning
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
RVG 12450
FERRING B.V.
NL
not available
RVG 11778
FERRING B.V.
NL
not available
RVG 11779
FERRING B.V.
NL
NL/H/1427/001
RVG 33462
FERRING B.V.
NL
NL/H/0263/001
RVG 25383
FERRING B.V.
NL
NL/H/1427/001
09-7253
FERRING LEGEMIDLER AS
NO
SE/H/0663/001
06-4553
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
NO
DE/H/0566/001
06-4035
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
NO
DE/H/0492/002
08-6248
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
NO
DE/H/0492/001
04-2772
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
NO
NL/H/1427/001
09-7253
FERRING LEGEMIDLER AS
NO
List of nationally authorised medicinal products EMA/173192/2017
Page 20/26
Product Name (in authorisation country) DECAPEPTYL 0,1 mg, 0,1 mg/ml, roztwór do wstrzykiwań Gonapeptyl Daily, 0,1 mg/1 ml, roztwór do wstrzykiwań DECAPEPTYL DEPOT, 3,75 mg, proszek i rozpuszczalnik do sporządzania zawiesiny do wstrzykiwań Diphereline SR 11,25 mg; 11,25 mg; proszek i rozpuszczalnik do sporzadzania zawiesiny o przedluzonym uwalnianiu do wstrzykiwan Diphereline SR 22,5 mg, proszek i rozpuszczalnik do sporządzenia zawiesiny o przedłużonym uwalnianiu do wstrzykiwań DECAPEPTYL 0,1 mg, 0,1 mg/ml, roztwór do wstrzykiwań DECAPEPTYL DEPOT, 3,75 mg, proszek i rozpuszczalnik do sporządzania zawiesiny do wstrzykiwań Gonapeptyl Daily, 0,1 mg/1 ml, roztwór do wstrzykiwań
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
9459
FERRING GMBH
PL
NL/H/1427/001
15578
FERRING GMBH
PL
not available
R/3661
FERRING GMBH
PL
not available
8944
IPSEN PHARMA
PL
DE/H/0492/002
17882
IPSEN PHARMA
PL
not available
9459
FERRING GMBH
PL
not available
R/3661
FERRING GMBH
PL
NL/H/1427/001
15578
FERRING GMBH
PL
List of nationally authorised medicinal products EMA/173192/2017
Page 21/26
Product Name (in authorisation country)
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
4869
IPSEN PHARMA
PL
not available
8869
IPSEN PHARMA
PL
NL/H/0263/001
386 20 83
PT
GONAPEPTYL DEPOT 3,75mg Pó e veículo para suspensão injectável
NL/H/0263/001
386 21 82
Fertipeptil 0,1 mg/1 ml solução injetável
NL/H/1427/001
5184106
Decapeptyl 0,1 mg, pó e solvente para solução injetável Decapeptyl LP 22,5 mg/2 ml pó e veículo para suspensão injetável Fertipeptil 0,1 mg/1 ml solução injetável
not available
3283587
FERRING PORTUGUESA – PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA. FERRING PORTUGUESA – PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA. FERRING PORTUGUESA – PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA. IPSEN PORTUGAL PRODUTOS FARMACÊUTICOS, S.A.
not available
5252770
IPSEN PORTUGAL PRODUTOS FARMACÊUTICOS, S.A.
PT
NL/H/1427/001
5184106
FERRING PORTUGUESA – PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA.
PT
Diphereline SR 3,75; 3,75 mg; proszek i rozpuszczalnik do sporządzania zawiesiny o przedłużonym uwalnianiu do wstrzykiwań Diphereline 0,1 mg 0,1 mg proszek i rozpuszczalnik do sporządzania roztworu do wstrzykiwań GONAPEPTYL DEPOT 3,75mg Pó e veículo para suspensão injectável
List of nationally authorised medicinal products EMA/173192/2017
PT
PT
PT
Page 22/26
Product Name (in authorisation country)
MRP/DCP Authorisation number NL/H/0263/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
386 20 83
PT
GONAPEPTYL DEPOT 3,75mg Pó e veículo para suspensão injectável
NL/H/0263/001
386 21 82
Decapeptyl LP 11,25 mg/2 ml pó e veículo para suspensão injetável Decapeptyl 3,75 mg/2 ml pó e veículo para suspensão injetável Gonapeptyl Zilnic 0,1 mg/1 ml soluţie injectabilă Gonapeptyl Zilnic 0,1 mg/1 ml soluţie injectabilă Gonapeptyl Zilnic 0,1 mg/1 ml soluţie injectabilă Diphereline 22,5 mg pulbere și solvent pentru suspensie injectabilă cu eliberare prelungită DIPHERELINE 0,1 mg, pulbere şi solvent pentru soluţie injectabilă Diphereline PR 11,25 mg pulbere şi solvent pentru suspensie injectabilă cu eliberare prelungită
not available
2891588
FERRING PORTUGUESA – PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA. FERRING PORTUGUESA – PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA. IPSEN PORTUGAL PRODUTOS FARMACÊUTICOS, S.A.
not available
2047280
IPSEN PORTUGAL PRODUTOS FARMACÊUTICOS, S.A.
PT
NL/H/1427/001
6319/2014/02
FERRING GMBH
RO
NL/H/1427/001
6319/2014/01
FERRING GMBH
RO
NL/H/1427/001
6319/2014/02
FERRING GMBH
RO
not available
8689/2016/01
IPSEN PHARMA
RO
not available
8209/2006/01
IPSEN PHARMA
RO
not available
2081/2009/01
IPSEN PHARMA
RO
GONAPEPTYL DEPOT 3,75mg Pó e veículo para suspensão injectável
List of nationally authorised medicinal products EMA/173192/2017
PT
PT
Page 23/26
Product Name (in authorisation country) Gonapeptyl Zilnic 0,1 mg/1 ml soluţie injectabilă Diphereline 3,75 mg, pulbere şi solvent pentru suspensie injectabilă cu eliberare prelungită Gonapeptyl Depot, 3,75 mg, pulver och vätska till injektionsvätska, suspension Gonapeptyl 0,1 mg/ml injektionsvätska, lösning Pamorelin 11,25 mg pulver och vätska till injektionsvätska, depotsuspension Pamorelin 3,75 mg pulver och vätska till injektionsvätska, suspension Pamorelin 22,5 mg pulver och vätska till injektionsvätska, depotsuspension Moapar 11,25 mg pulver och vätska till injektionsvätska, suspension Gonapeptyl Depot, 3,75 mg, pulver och vätska till injektionsvätska, suspension Gonapeptyl 0,1 mg/ml injektionsvätska, lösning Gonapeptyl 0,1 mg/1 ml raztopina za injiciranje
MRP/DCP Authorisation number NL/H/1427/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
6319/2014/01
FERRING GMBH
RO
not available
2080/2009/01
IPSEN PHARMA
RO
NL/H/0263/001
17299
FERRING LÄKEMEDEL AB
SE
NL/H/1427/001
43503
FERRING LÄKEMEDEL AB
SE
DE/H/0492/001
21201
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
SE
not available
12602
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
SE
DE/H/0492/002
44590
INSTITUT PRODUITS SYNTHÈSE (IPSEN) AB
SE
SE/H/0663/001
21964
SODIA
SE
NL/H/0263/001
17299
FERRING LÄKEMEDEL AB
SE
NL/H/1427/001
43503
FERRING LÄKEMEDEL AB
SE
NL/H/1427/001
5363-I-1515/13
FERRING GMBH
SI
List of nationally authorised medicinal products EMA/173192/2017
Page 24/26
Product Name (in authorisation country) Gonapeptyl 0,1 mg/1 ml raztopina za injiciranje Pamorelin 22,5 mg prašek in vehikel za suspenzijo za injiciranje s podaljšanim sproščanjem DIPHERELINE 0,1 mg prašek in vehikel za raztopino za injiciranje Gonapeptyl 0,1 mg/1 ml raztopina za injiciranje Gonapeptyl 0,1 mg/1 ml raztopina za injiciranje DIPHERELINE 3,75 mg prašek in vehikel za suspenzijo za injiciranje DIPHERELINE 11,25 mg prašek in vehikel za suspenzijo za injiciranje DECAPEPTYL DEPOT 3,75 mg Prášok a disperzné prostredie na injekčnú suspenziu DECAPEPTYL 0,1 mg injekcný roztok Diphereline S.R. 3,75 mg Prášok a disperzné prostredie na injekčnú suspenziu Diphereline S.R. 22,5 mg prášok a disperzné prostredie na injekčnú suspenziu s predĺženým uvoľňovaním Diphereline 0,1 mg Prášok a rozpúšťadlo na injekčný roztok
MRP/DCP Authorisation number NL/H/1427/001
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
5363-I-1516/13
FERRING GMBH
SI
DE/H/0492/002
H/11/01213/001
IPSEN PHARMA
SI
not available
H/02/00478/001
IPSEN PHARMA
SI
NL/H/1427/001
5363-I-1515/13
FERRING GMBH
SI
NL/H/1427/001
5363-I-1516/13
FERRING GMBH
SI
not available
H/02/00478/002
IPSEN PHARMA
SI
not available
H/02/00478/003
IPSEN PHARMA
SI
not available
44/0635/94-S
FERRING GMBH
SK
not available
44/0162/88-CS
FERRING GMBH
SK
not available
56/0194/00-S
IPSEN PHARMA
SK
DE/H/0492/002
56/0933/10-S
IPSEN PHARMA
SK
not available
56/0193/00-S
IPSEN PHARMA
SK
List of nationally authorised medicinal products EMA/173192/2017
Page 25/26
Product Name (in authorisation country) DECAPEPTYL 0,1 mg injekcný roztok DECAPEPTYL DEPOT 3,75 mg Prášok a disperzné prostredie na injekčnú suspenziu Diphereline S.R. 11,25 mg Prášok a disperzné prostredie na injekčnú suspenziu GONAPEPTYL DEPOT 3.75 mg Powder and solvent for suspension for injection GONAPEPTYL DEPOT 3.75 mg Powder and solvent for suspension for injection Decapeptyl SR 11.25 mg, powder and solvent for suspension for injection Salvacyl, 11.25 mg powder and solvent for prolonged-release suspension for injection Decapeptyl SR 22.5 mg powder and solvent for suspension for injection Decapeptyl SR 3 mg, powder for suspension for injection
MRP/DCP Authorisation number not available
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
44/0162/88-CS
FERRING GMBH
SK
not available
44/0635/94-S
FERRING GMBH
SK
not available
56/0069/01-S
IPSEN PHARMA
SK
NL/H/0263/001
PL 03194/0085
FERRING PHARMACEUTICALS LTD.
UK
NL/H/0263/001
PL 03194/0085
FERRING PHARMACEUTICALS LTD.
UK
not available
PL 34926/0019
IPSEN LTD
UK
SE/H/0663/001
PL 034926/0012
IPSEN LTD
UK
not available
PL 34926/0013
IPSEN LTD
UK
not available
PL 34926/0002
IPSEN LTD
UK
List of nationally authorised medicinal products EMA/173192/2017
Page 26/26
