natgillin/translations-raw huggingface dataset:
CHMP постигна съгласие относно окончателния текст в листовката.
The final PL wording was agreed by the CHMP.
Моля, вижте КХП за Seroquel и Seroquel XR в приложение III.
Please see SmPC for Seroquel and Seroquel XR in Annex III.
В началото на тази процедура формулировката по точка 4.6. беше обект на оценка в изменение тип II по ПВП.
At the start of this procedure, the wording on section 4.6 was under evaluation in an MRP type II variation.
В началото на настоящата процедура текстът по точка 4.9 беше обект на оценка в изменение тип II по ПВП.
At the start of this procedure, the wording on section 4.9 was under evaluation in an MRP type II variation.
„Лечението на шизофрения, включващо превенцията на рецидив при стабилни пациенти с шизофрения, които са на поддържащо лечение със Seroquel XR“ е изпуснат, в сравнение с КХП по ПВП.
Seroquel XR wording was disharmonised by one MS in which the following text: “Treatment of Schizophrenia, including preventing relapse in stable schizophrenic patients who have been maintained on Seroquel XR” was omitted in comparison with the MRP SmPC.
Ефекти върху черния дроб
Hepatic Effects
Бяха установени всички различия и беше прието, че хармонизираният текст ще бъде изменен според формулировката в КХП по ПВП за Seroquel и Seroquel XR. Моля, вижте КХП за Seroquel и Seroquel XR в приложение III.
All divergences have been identified and it was agreed that the harmonised text would be aligned with the wording of the MRP SmPC for Seroquel and Seroquel XR.
Бяха направени изменения в листовката на продукта в съответствие с измененията в КХП.
Following all the changes in the SmPC there were amendments made to the Package Leaflet.
В началото на настоящата процедура формулировката на тази точка беше обект на оценка в изменение тип II по ПВП.
At the start of this procedure, the wording on this section was under evaluation in an MRP type II variation.
Предложеният хармонизиран текст отразява по-точно настоящите данни и знания относно Seroquel и Seroquel XR. Моля, вижте КХП за Seroquel и Seroquel XR в приложение III.
The proposed, harmonised text more accurately reflects the current data and knowledge on Seroquel and Seroquel XR.
Беше постигнато съгласие хармонизираната формулировка, свързана с точка 4.5, да бъде вече одобрената КХП по ПВП за Seroquel и Seroquel XR. Моля вижте КХП за Seroquel и Seroquel XR в приложение III.
It was agreed that the harmonised wording related to section 4.5 is the already approved Seroquel and Seroquel XR MRP SmPC.
Моля, вижте КХП за Seroquel и Seroquel XR и свързани с тях имена в приложение III.
Please see Product Information for Seroquel and for Seroquel XR and associated names in Annex III.
„Пациентите следва да се наблюдават за признаци и симптоми на инфекция, както и да се проследява броят на неутрофилите, докато превиши 1,5 Х 109/l“.
Redundant text related to resolution of leucopenia and/or neutropenia following cessation of quetiapine treatment because recovery is implied later in the same paragraph i.e. “Patients should be observed for signs and symptoms of infection and neutrophil counts followed until they exceed 1.5 X 109/l” was removed.
Във всички държави членки формулировката, свързана с предклиничните данни за безопасност в КХП за Seroquel и Seroquel XR е еднаква или подобна.
All MSs have the same or similar wording in their Seroquel and Seroquel XR SmPCs with regards to preclinical safety data.
Окончателно одобрената формулировка е част от хармонизираната КХП за Seroquel и Serouqel XR. Моля, вижте приложение III
The final agreed wording is part of the harmonised SmPCs for Seroquel and for Seroquel XR.
Приложение I).
Please see Annex III.
Поради комбинирането на ПВП/ДЦП и разрешения за употреба, дадени на национално равнище, бяха открити различия в информацията за продукта (ИП) за Seroquel и Seroquel XR. Вследствие на това тези медицински продукти бяха включени в списъка на продукти за хармонизиране на информацията за продукта, изготвен от Координационната група за процедурата по взаимно признаване и за децентрализираната процедура - лекарствени продукти за хуманна употреба (CMD(h)) в съответствие с член 30, параграф 2 от Директива 2001/83/ЕО.
Hence, these medicinal products were included in the list of products for PI harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC.
169 27 Solna
169 27 Solna Sweden
75014 Paris- Франция
75014 Paris- France
94250 Gentilly- Франция
94250 Gentilly- France
FR - Франция NOVO NORDISK PHARMACEUTIQUE SAS Le Palatin
FR - France NOVO NORDISK PHARMACEUTIQUE SAS Le Palatin
ES - Испания LILLY, S.A. Avda.
ES - Spain LILLY, S.A. Avda.
de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas 28108
de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas 28108 MADRID
ES - Испания FERRING, S.A.U Gobelas, 11.
ES - Spain FERRING, S.A.U Gobelas, 11.
Lagoas Park, Edifício 10, 2740-271 Porto Salvo
Lagoas Park, Edifício 10, 2740-271 Porto Salvo Portugal
IS - Исландия Pfizer APS Lautrupvang 8
IS - Iceland Pfizer APS Lautrupvang 8
1100 Wien, Австрия
1100 Wien, Austria
IS - Исландия Novo Nordisk AS Novo Allé
IS - Iceland Novo Nordisk AS Novo Allé
s r.o., Stroupežnického 17, 150 00 Praha 5, Чешка република
s r.o., Stroupežnického 17, 150 00 Praha 5, Czech Republic
Via Valbondione 113 00188 Rome, Италия
Via Valbondione 113 00188 Rome Italy
AT - Австрия Pfizer Corporation Austria Gesellschaft m.b.H.
AT - Austria Pfizer Corporation Austria Gesellschaft m.b.H.
203 11 Malmö
203 11 Malmö Sweden
AT - Австрия Eli Lilly GmbH Kölblgasse 8- 10
AT - Austria Eli Lilly GmbH Kölblgasse 8- 10
Flemingweg 18, 2408 AV ALPHEN A/D RIJN
Flemingweg 18, 2408 AV ALPHEN A/D RIJN Nederland
ES - Испания MERCK S.L.Maria de Molina, 40 28006
ES - Spain MERCK S.L.Maria de Molina, 40 28006 Madrid
FR - Франция MERCK SANTE 37, rue Saint-Romain 69008 Lyon, Франция
FR - France MERCK SANTE 37, rue Saint-Romain 69008 Lyon France
28023 Madrid, Испания
28023 Madrid
Lisboa, Португалия
Lisboa, Portugal
Pfizer BV, Rivium Westlaan 142, 2909 LD CAPELLE A/D IJSSEL D
Pfizer BV, Rivium Westlaan 142, 2909 LD CAPELLE A/D IJSSEL D - Nederland
FR - Франция LILLY France 13, rue Pagès
FR - France LILLY France 13, rue Pagès
SE - Швеция Ferring Läkemedel AB Box 4041
Ferring Läkemedel AB Box 4041
- Франция FERRING SAS 7, rue Jean-Baptiste Clément
FR - France FERRING SAS 7, rue Jean-Baptiste Clément
Списък на имената, лекарствена/и форма/и, количество на активното вещество в дозова единица, в %, за даден обем или маса, път/ища на въвеждане на лекарствения/те продукт/и, притежател/и на разрешение за употреба в държавите членки
List of the invented name(s), pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
AT - Австрия Merck Gesellschaft mbH Zimbagasse 5
AT - Austria Merck Gesellschaft mbH Zimbagasse 5
SE - Швеция Eli Lilly Sweden AB Box 721
Eli Lilly Sweden AB Box 721
PT - Португалия Merck, S.A. Rua Alfredo da Silva, 3 C, 1300-040
Merck, S.A. Rua Alfredo da Silva, 3 C, 1300-040
- Франция SANOFI AVENTIS France 1-13, boulevard Romain Rolland
FR - France SANOFI AVENTIS France 1-13, boulevard Romain Rolland
DK 2750 Ballerup
DK 2750 Ballerup Denmark
- Финландия Pfizer Oy, Tietokuja 4, 00330 Helsinki,
FI - Finland Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finland
PFIZER SA Bld de la Plaine,17 1050 Brussels
PFIZER SA Bld de la Plaine,17 1050 Brussels Belgium
Rua Cesário Verde, nº 5, 4º Piso, Linda-a-Pastora, 2790-326 Queijas,
Rua Cesário Verde, nº 5, 4º Piso, Linda-a-Pastora, 2790-326 Queijas, Portugal
ELI LILLY ČR, s.r.o., Pobřežní 12, 180 00 Praha 8, Чешка република
ELI LILLY ČR, s.r.o., Pobřežní 12, 180 00 Praha 8, Czech Republic
Ferring Lægemidler A/S, Kay Fiskers Plads 11, DK-2300 Købenahvn S,
Ferring Lægemidler A/S, Kay Fiskers Plads 11, DK2300 Købenahvn S, Denmark
NOVO NORDISK HELLAS Panagouli 80 & Agias Triadas 65, Agia Paraskevi 15343,
EL - Greece NOVO NORDISK HELLAS Panagouli 80 & Agias Triadas 65, Agia Paraskevi
Ferring BV Polariavenue 132 2132JX
Ferring BV Polariavenue 132 2132JX HoofddorpNederland
- Исландия Eli Lilly Danmark Nybrovej 110
IS - Iceland Eli Lilly Danmark Nybrovej 110
BAKER ITALIA SpA VIA DI PORTA PINCIANA, 6 00187
IT - Italy BAKER ITALIA SpA VIA DI PORTA PINCIANA, 6 00187 ROMA
Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, West Sussex RH11 9RT,
Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, West Sussex RH11 9RT, UK
Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup,
Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, Denmark
NO - Норвегия Pfizer AS, Postboks 3, 1324 Lysaker, Норвегия
Pfizer AS, Postboks 3, 1324 Lysaker, Norway
- Португалия Ferring PortuguesaProdutos Farmacêuticos, Sociedade Unipessoal, Lda.
Ferring PortuguesaProdutos Farmacêuticos, Sociedade Unipessoal, Lda.
- Словения Eli Lilly farmacevtska družba, d.o.o., Brnčičeva 41g, 1231 Ljubljana
Eli Lilly farmacevtska družba, d.o.o., Brnčičeva 41g, 1231 LjubljanaČrnuče, Slovenia
1138 Budapest
1138 Budapest Hungary
1113 Budapest
1113 Budapest Hungary
- Финландия Eli Lilly Finland Oy Ab, Rajatorpantie 41 C, PL 16, 01641 Vantaa,
FI - Finland Eli Lilly Finland Oy Ab, Rajatorpantie 41 C, PL 16, 01641 Vantaa, Finland
DE - Германия Lilly Deutschland GmbH Teichweg 3
Lilly Deutschland GmbH Teichweg 3
ROMA, Италия
Roma, Italy
NO - Норвегия Elly Lilly Norge AS, Grensevien 99, 0663
Elly Lilly Norge AS, Grensevien 99, 0663 Oslo, Norway
Ferring Phamraceuticals Limited, The Courtyard, Waterside Drive, Langley, Berkshire SL3
Ferring Phamraceuticals Limited, The Courtyard, Waterside Drive, Langley, Berkshire SL3 6EZ, UK
Bagsvaerd, Дания
Bagsvaerd, Denmark
DE - Германия Merck Serono GmbH Alsfelder Str. 17
Merck Serono GmbH Alsfelder Str. 17
ELI LILLY BENELUX SA Rue de l'Etuve 52/1 1000 Brussels
ELI LILLY BENELUX SA Rue de l'Etuve 52/1 1000 Brussels Belgium
Pfizer Health AB, Vetenskapsvagen 10,SE191 90 Sollentuna,
LV - Latvia Pfizer Health AB, Vetenskapsvagen 10,SE191 90 Sollentuna, Sweden
FERRING NV Hopmarkt 9 b3 9300 Aalst
FERRING NV Hopmarkt 9 b3 9300 Aalst Belgium
DE - Германия Pharmacia GmbH Linkstr.
Pharmacia GmbH Linkstr.
- Испания PFIZER, S.A.Avda.
ES - Spain PFIZER, S.A.Avda.
Hauptstraße 1
Floridsdorfer Hauptstraße 1
- Финландия Ferring Lääkkeet Oy, Piispansilta 11 A, PL 23, 02241 Espoo,
FI - Finland Ferring Lääkkeet Oy, Piispansilta 11 A, PL 23, 02241 Espoo, Finland
NO - Норвегия Ferring Legemidler AS, Postboks 4445, 0403
Ferring Legemidler AS, Postboks 4445, 0403 Oslo, Norway
FR - Франция PFIZER HOLDING France 23-25, avenue du
FR - France PFIZER HOLDING France 23-25, avenue du Docteur Lannelongue
PT - Португалия Lilly-Portugal, Produtos Farmacêuticos, Lda.
Lilly-Portugal, Produtos Farmacêuticos, Lda.
Pfizer Italia S.r.l.
IT - Italy Pfizer Italia S.r.l.
Merck Serono S.p.A., Via Casilina 125, I-00176
LV - Latvia Merck Serono S.p.A., Via Casilina 125, I-00176
FERRING HELLAS S.A. GKYZI 3, MAROUSI 15125, Гърция
EL - Greece FERRING HELLAS S.A. GKYZI 3, MAROUSI 15125
- Финландия Merck Oy, Pihatörmä 1 C, 02240 Espoo,
FI - Finland Merck Oy, Pihatörmä 1 C, 02240 Espoo, Finland
3991 RA HOUTEN
3991 RA HOUTEN Nederland
José - Piso 1, 2780-730 Paço d' Arcos,
Quinta da FonteEdifício D. José - Piso 1, 2780-730 Paço d' Arcos, Portugal
AT - Австрия Novo Nordisk Pharma GmbH
AT - Austria Novo Nordisk Pharma GmbH
D-24109 Kiel, Германия hGH-Ferring 12 (4 mg)
D-24109 Kiel hGH-Ferring 12 (4 mg) 4.32 mg
Wienerbergstr.
Brucknerstr.
00176 Roma, Италия
00176 Roma Italy
Pfizer Hellas S.A. 234, Messoghion Ave., Neo Psychiko 15451, Athens,
EL - Greece Pfizer Hellas S.A. Messoghion Ave., Neo Psychiko 15451, Athens, Greece
BG - България Pfizer Enterprises SARL, Rond-point du Kirchberg, 51, Avenue J.F.Kennedy, L-1855 Luxembourg,
Pfizer Enterprises SARL, Rond-point du Kirchberg, 51, Avenue J.F.Kennedy, L1855 Luxembourg, Luxembourg
HU - Унгария Merck Kft.
Merck Kft.
DK-2880 Bagsværd
DK-2880 Bagsværd Denmark
Serono Limted, Bedfont Cross, Stanwell Road, Feltham, Middlesex TW14 8NX,
Serono Limted, Bedfont Cross, Stanwell Road, Feltham, Middlesex TW14 8NX, UK
ZOMACTON 4 mg (12 UI)
ZOMACTON 4 mg (12UI) 4 mg (12UI)
FARMASERV LILLY AEBE 15TH Km NATIONAL HIGHWAY ATHENSLAMIA
EL - Greece FARMASERV LILLY AEBE 15TH Km NATIONAL HIGHWAY ATHENS-LAMIA KIFISSIA 14564, P.O.
ET - Естония Merck Serono S.p.A.
ET - Estonia Merck Serono S.p.A.
TW14 8NX, England,
8NX, England
Merck A.E. Hellas Kifisias Avenue 41-45 (Building B) Marousi 15123
EL - Greece Merck A.E. Hellas Kifisias Avenue 41-45 (Building B)
8 mg (24 NE) /1,5 ml
8mg (24 NE) /1,5ml parenteral use
NO - Норвегия Merck AB, 195 87 Stockholm, Швеция
Merck AB, 195 87 Stockholm, Sweden
SAIZEN (CLICK.EASY) 8 mg (5,83 mg/ml)
SAIZEN (CLICK.EASY) 8 mg (5,83 mgml)
IE - Ирландия Pharmacia Laboratories Limited, Ramsgate Road, Sandwich, Kent, CT13
IE - Ireland Pharmacia Laboratories Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Eli Lilly Holdings Limited, Lilly House Priestley Road Basingstoke Hampshire RG24 9NL,
Eli Lilly Holdings Limited, Lilly House Priestley Road Basingstoke Hampshire RG24 9NL, United Kingdom
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ,
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
6EZ, Великобритания
UK - United Kingdom
DE - Германия Novo Nordisk Pharma GmbH
Novo Nordisk Pharma GmbH
SE - Швеция Novo Nordisk A/S Novo Allé
Novo Nordisk A/S Novo Allé
Eli Lilly & Company Limited, Lilly House, Priestly Road, Basingstoke, Hampshire RG24 9NL,
Eli Lilly & Company Limited, Lilly House, Priestly Road, Basingstoke, Hampshire RG24 9NL, UK
DK-2880 Bagsvaerd
DK-2880 Bagsvaerd Denmark
Industria Farmaceutica Serono S.p. A Via Casilina, 125, Rome, 00176, Италия
Via Casilina, 125, Rome, 00176, Italy
Eli Lilly Danmark A/S, Nybrovej 110, DK-2800 Kongens Lyngby, Дания
Eli Lilly Danmark A/S, Nybrovej 110, DK-2800
- Словения NovoNordis A/S, Novo Alle, Basvaerd, Дания
NovoNordis A/S, Novo Alle, Basvaerd, DK
- Ирландия Serono Limited, Bedfont Cross, Stanwell Road, Feltham, Middlesex,
IE - Ireland Serono Limited, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14
SE - Швеция E. Merck AB 195 87 Stockholm
E. Merck AB 195 87 Stockholm Sweden
ZOMACTON 10 mg/ml, poudre et solvant pour solution injectable en seringue préremplie
ZOMACTON 10 mg/ml, poudre et solvant pour solution injectable en seringue préremplie subcutaneous
Белгия
BEBelgium
FERRING SpA VIA SENIGALLIA, 18/2 20161 MILANO, Италия
IT - Italy FERRING SpA VIA SENIGALLIA, 18/2
Инжекция
Injektionslösung
Pfizer Europe MA EEIG., Sandwich, Kent, CT13,
Pfizer Europe MA EEIG., Sandwich, Kent, CT13, 9NJ, United Kingdom
- Исландия Merck AB SE-195 87 Stockholm
IS - Iceland Merck AB SE-195 87 Stockholm Sweden
AT - Австрия Ferring Arzneimittel GmbH
AT - Austria Ferring Arzneimittel GmbH Wienerbergstr.
Magna Drive, Magna Business Park, Citywest Road, Dublin 24,
IE - Ireland Ferring Ireland Ltd., United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
SAIZEN CLICKEASY 8 mg, poudre et solvant pour solution injectable
SAIZEN CLICKEASY 8 mg, poudre et solvant pour solution injectable subcutaneous
SAIZEN 8 mg, poudre et solvant pour solution injectable
SAIZEN 8 mg, poudre et solvant pour solution injectable subcutaneous
DE - Германия Ferring GmbH Wittland 11
ET - Estonia Ferring GmbH Wittland 11
- Естония Ferring GmbH Wittland 11
Ferring GmbH Wittland 11
HU - Унгария Ferring Magyarország Kft.
Ferring Magyarország Kft. Váci út 140.
Нидерландия
NLNetherlands
ELI LILLY ITALIA SpA VIA GRAMSCI, 731/733 SESTO FIORENTINO 50019 FIRENZE, Италия
IT - Italy ELI LILLY ITALIA SpA VIA GRAMSCI, 731/733
ZOMACTON 4 mg, poudre et solvant pour solution injectable en multidose
ZOMACTON 4 mg, poudre et solvant pour solution injectable en multidose subcutaneous
30 rue de Valmy
30 rue de Valmy 92800 Puteaux-France
Zomacton 10 mg powder and solvent for solution for injection in pre-filled syringe
Zomacton 10 mg powder and solvent for solution for injection in pre-filled syringe powder and solvent for solution for injection in pre-filled syringe
Pfizer Europe MA EEIG Ramsgate Road, CT13 9 NJ, Sandwich, Kent,
PL - Poland Pfizer Europe MA EEIG Ramsgate Road, CT13 9 NJ, Sandwich, Kent, United Kingdom
MAXOMAT 1,3 mg, poudre et solvant pour solution injectable
MAXOMAT 1,3 mg, poudre et solvant pour solution injectable subcutaneous
ZOMACTON 4 mg polvo y disolvente en jeringa precargada para solución inyectable
ZOMACTON 4 mg polvo y disolvente en jeringa precargada para solución inyectable powder for solution Subcutaneous use
1123 Budapest
Alkotás u. 53 1123 Budapest Hungary
click easy 8 mg 8 mg
Saizen click easy 8 mg 8 mg s.c.
Humatrope 24 mg prašek in vehikel za raztopino
Humatrope 24 mg prašek in vehikel za raztopino in injiciranje
ZOMACTON 10 mg/ ml polvo y disolvente en jeringa precargada para solución inyectable
ZOMACTON 10 mg/ ml polvo y disolvente en jeringa precargada para solución inyectable powder for solution Subcutaneous use
HUMATROPE 72 NE (24 mg) injekció patronban
HUMATROPE 72 NE (24 mg) injekció patronban powder and solvent for injection
SAIZEN 8 mg click.easy polvo y disolvente para solución inyectable
SAIZEN 8 mg click.easy polvo y disolvente para solución inyectable powder for solution Subcutaneous use
HUMATROPE 18 NE (6 mg) injekció patronban
HUMATROPE 18 NE (6 mg) injekció patronban powder and solvent for injection
UMATROPE 24 mg/3 ml, poudre et solvant pour solution injectable
UMATROPE 24 mg/3 ml, poudre et solvant pour solution injectable subcutaneous
SK - Словакия Merck Serono S.p.A.
IT - Italy Merck Serono S.p.A.
SAIZEN 3,33 mg, poudre et solvant pour solution injectable
SAIZEN 3,33 mg, poudre et solvant pour solution injectable subcutaneous
Подкожно приложение, интрамускулно приложение
Subcutaneous use; Intramuscular use
Humatrope 6 mg prašek in vehikel za raztopino
Humatrope 6 mg prašek in vehikel za raztopino in injiciranje
UMATROPE 6 mg/3 ml, poudre et solvant pour solution injectable
UMATROPE 6 mg/3 ml, poudre et solvant pour solution injectable subcutaneous
2795-240 Linda-a-Velha,
Rua Alexandre HerculanoEdifício 1, Piso 6, 2795-240 Linda-a-Velha, Portugal
Bedfont Cross, Stanwell Road
MT - Malta Serono Ltd Bedfont Cross, Stanwell Road
Humatrope 12 mg For Injection
Humatrope 12mg For Injection powder for injection subcutaneous use
SAIZEN 1,33 mg, poudre et solvant pour solution injectable
SAIZEN 1,33 mg, poudre et solvant pour solution injectable subcutaneous
15 mg/1,5 ml oldatos injekció
15MG/1.5ML SOLUTION FOR INJECTION
Novo Nordisk A/S Novo Alle, Bagsvaerd, DK-2880, Дания
PL - Poland Novo Nordisk A/S Novo Alle, Bagsvaerd, DK2880, Denmark
UMATROPE 12 mg/3 ml, poudre et solvant pour solution injectable
UMATROPE 12 mg/3 ml, poudre et solvant pour solution injectable subcutaneous
Norditropin SimpleXx
Norditropin Simplex
Инжекционен разтвор в предварително напълнена писалка
Solution for injection in pre-filled pen
51,Avenue J.F.Kennedy L-1855
Pfizer Luxembourg SARL, 51 av. J.-F. Kennedy, 1855 Luxembourg
HUMATROPE 24 mg polvo y disolvente para solución inyectable
HUMATROPE 24 mg polvo y disolvente para solución inyectable powder for solution Subcutaneous use
ES - Испания NOVO NORDISK A/SNovo
ES - Spain NOVO NORDISK A/SNovo AlleBagsvaerdDK-2880
Humatrope 12 mg prašek in vehikel za raztopino
Humatrope 12 mg prašek in vehikel za raztopino in injiciranje
NOVO NORDISK PHARMA SA Boulevard international
NOVO NORDISK PHARMA SA
HUMATROPE 36 NE (12 mg) injekció patronban
HUMATROPE 36 NE (12 mg) injekció patronban powder and solvent for injection
Genotropin 36 IU (12 mg) powder and solvent for solution for injection
36 IU (12 mg) powder and solvent for solution for injection
RO - Румъния NOVO NORDISK A/S Novo Allé, DK-2880
IT - Italy NOVO NORDISK A/S Novo Allé DK-2880
Humatrope 24 mg For Injection
Humatrope 24mg For Injection powder for injection subcutaneous use
HUMATROPE 6 mg polvo y disolvente para solución inyectable
HUMATROPE 6 mg polvo y disolvente para solución inyectable powder for solution Subcutaneous use
Eli Lilly & Co. Ltd.
Eli Lilly ČR, s.r.o.
- Финландия Novo Nordisk A/S, Novo Allé, 2880 BAGSVAERD,
FI - Finland Novo Nordisk A/S, Novo Allé, 2880 BAGSVAERD, Denmark
CY - Кипър NOVO NORDISK A/S, Novo Allé, DK-2880
CY - Cyprus NOVO NORDISK A/S, Novo Allé, DK-2880 BAGSVAERD, DENMARK
HU - Унгария Pfizer Kft.
Pfizer Kft.
5 mg/ 1,5 mg Инжекционен разтвор в предварително напълнена писалка
5 mg/ 1,5 mg Solution for injection in pre-filled pen
in injiciranje
Subcutanous injection
Швеция
Denmark
HUMATROPE 12 mg polvo y disolvente para solución inyectable
HUMATROPE 12 mg polvo y disolvente para solución inyectable powder for solution Subcutaneous use
Ferring GmbH, Wittland 11, D-24109 Kiel,
Ferring GmbH,Wittland 11, D-24109 Kiel, Germany
Novo Nordisk A/S, Novo Allé, 2880 Bagsvaerd,
Novo Nordisk A/S, Novo Allé, 2880 Bagsvaerd, Denmark
LT - Литва
LTLithuania
NO - Норвегия NovoNordisk A/S, Novo Allé, 2880 Bagsværd,
NovoNordisk A/S, Novo Allé, 2880 Bagsværd, Danmark
FR
SC
Прах и разтворител за инфузионен разтвор
powder for injection intramuscular and subcutaneous use
Интрамускулно и подкожно приложение
Subcutaneous Intramuscular
ET - Естония Pfizer Enterprises SARL Round-Point du
ET - Estonia Pfizer Enterprises SARL Round-Point du Kirchberg 51,Avenue J.F.Kennedy L-1855
NOVO NORDISK A/S Novo Allé DK-2880 Bagsvaerd
Novo Nordisk A/S, Novo Allé DK-2880 Bagsværd, Denmark
Инжекционен разтвор в еднодозова опаковка
Solution for injection Single dose container s.c.
PT - Португалия Novo Nordisk - Comércio de Produtos
Novo Nordisk - Comércio de Produtos Farmacêuticos, Lda.
Norditropin Simplex 5 mg/1,5 ml solution for injection
Norditropin SimpleXx 5 mg / 1,5 mL solution for injection injection
186 00 Praha
20161 MILANO
Norditropin NordiFlex 10 mg/1.5 ml, solution for injection, in pre-filled pen
Norditropin NordiFlex 10 mg/1.5 mL Solution for injection, prefilled syringe
Norditropin NordiFlex 5 mg/1.5 ml, solution for injection, in pre-filled pen
Norditropin NordiFlex 5 mg/1,5 mlInjektionslösung in einem Fertigpen solution for injection, in pre-filled pen
10 mg/1,5 mL Инжекционен разтвор в предварително напълнена писалка
10MG/1.5ML SOLUTION FOR INJECTION IN A PREFILLED PEN
Прах и разтворител за инжекционен разтвор в предварително напълнена спринцовка
Powder and solvent for solution for injection in pre-filled syringe
15 mg/1,5 mL Инжекционен разтвор в предварително напълнена писалка
15MG/1.5ML SOLUTION FOR INJECTION IN A PREFILLED PEN
10 MG/1,5 ML Инжекционен разтвор
10MG/1.5ML SOLUTION FOR INJECTION
Norditropin NordiFlex 15 mg/1.5 ml, solution for injection, in pre-filled pen
Norditropin NordiFlex 15 mg/1.5 mL Solution for injection, prefilled syringe
Инжекционен разтвор в предварително напълнена спринцовка
solution for injection in pre-filled syringe
NORDITROPIN NORDIFLEX 5 mg / 1.5 ml solución inyectable
Norditropin Nordiflex 5mg/1,5ml solution for injection subcutaneous
Norditropin SimpleXx 10 mg / 1.5 ml, solution for injection
Norditropin SimpleXx 10 mg / 1,5 mL solution for injection injection
Norditropin Simplexx 15 mg/1,5 ml Injektionslösung
Norditropin SimpleXx 15 mg/ 1,5 mL solution for injection injection
36 IU (12 mg)
(12 mg)
Genotropin Miniquick 1,4 mg/0,25 ml Прах и разтворител за инжекционен разтвор
Genotropin Miniquick 1.4 mg/0.25 ml Powder and solvent for solution for injection
Genotropin Miniquick 1,6 mg/0,25 ml Прах и разтворител за инжекционен разтвор
Genotropin Miniquick 1.6 mg/0.25 ml Powder and solvent for solution for injection
Genotropin Miniquick 1,2 mg/0,25 ml Прах и разтворител за инжекционен разтвор
Genotropin Miniquick 1.2 mg/0.25 ml Powder and solvent for solution for injection
Kirchberg
LULuxembourg
BG - България Ferring GmbH, Wittland 11, D-24109 Kiel,
LV - Latvia Ferring GmbH, Wittland 11, 24109 Kiel, Germany
Kiel
sc
Norditropin FlexPro 10 mg/1,5 ml Injektionslösung in einem Fertigpen
NORDITROPIN FlexPro 10 mg/1,5 ml solution for injection in pen
NORDITROPIN NORDIFLEX 15 mg/1,5 ml solución inyectable
Norditropin Nordiflex 15mg/1,5ml solution for injection subcutaneous
Genotropin Miniquick 0,2 mg/0,25 ml Прах и разтворител за инжекционен разтвор
Genotropin Miniquick 0.2 mg/0.25 ml Powder and solvent for solution for injection
NORDITROPIN NORDIFLEX 10 mg/1,5 ml solución inyectable
Norditropin Nordiflex 10mg/1,5ml solution for injection subcutaneous