ISSN 1977-091X
Official Journal
of the European Union
C 218
English edition
Information and Notices
Volume 62
28 June 2019
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ISSN 1977-091X |
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Official Journal of the European Union |
C 218 |
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English edition |
Information and Notices |
Volume 62 |
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Contents |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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European Commission |
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2019/C 218/01 |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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2019/C 218/02 |
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EN |
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IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
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28.6.2019 |
EN |
Official Journal of the European Union |
C 218/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2019 to 31 May 2019
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2019/C 218/01)
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— |
Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
|
Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
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3.5.2019 |
Palynziq |
pegvaliase |
BioMarin International Limited Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland |
EU/1/19/1362 |
Solution for injection |
A16AB19 |
8.5.2019 |
|
3.5.2019 |
Waylivra |
volanesorsen |
Akcea Therapeutics Ireland Limited Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland |
EU/1/19/1360 |
Solution for injection |
Pending |
8.5.2019 |
|
6.5.2019 |
Lorviqua |
lorlatinib |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België |
EU/1/19/1355 |
Film-coated tablet |
L01XE44 |
8.5.2019 |
|
6.5.2019 |
Pazenir |
paclitaxel |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/18/1317 |
Powder for dispersion for infusion |
L01CD01 |
8.5.2019 |
|
29.5.2019 |
Zynteglo |
autologous CD34+ cells encoding βΑ-T87Q-globin gene |
bluebird bio (Netherlands) B.V. Stadsplateau 7, 3521 AZ Utrecht, Nederland |
EU/1/19/1367 |
Dispersion for infusion |
Pending |
4.6.2019 |
|
— |
Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
|
3.5.2019 |
Clopidogrel Krka d.d. |
Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/09/562 |
8.5.2019 |
|
3.5.2019 |
Episalvan |
Amryt AG Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland |
EU/1/15/1069 |
8.5.2019 |
|
3.5.2019 |
PREZISTA |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/06/380 |
8.5.2019 |
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3.5.2019 |
Ryzodeg |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark |
EU/1/12/806 |
8.5.2019 |
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3.5.2019 |
Symtuza |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/17/1225 |
8.5.2019 |
|
3.5.2019 |
Yondelis |
Pharma Mar S.A. Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España |
EU/1/07/417 |
8.5.2019 |
|
6.5.2019 |
Dupixent |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/17/1229 |
9.5.2019 |
|
6.5.2019 |
Rezolsta |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/14/967 |
8.5.2019 |
|
6.5.2019 |
Ritonavir Mylan |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/17/1242 |
9.5.2019 |
|
6.5.2019 |
Twynsta |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/10/648 |
8.5.2019 |
|
13.5.2019 |
Ferriprox |
Apotex B.V. Keizersgracht 311, 1016 EE, Amsterdam, Nederland |
EU/1/99/108 |
15.5.2019 |
|
13.5.2019 |
Imnovid |
Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland |
EU/1/13/850 |
15.5.2019 |
|
13.5.2019 |
Mozobil |
Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |
EU/1/09/537 |
15.5.2019 |
|
13.5.2019 |
Ozempic |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark |
EU/1/17/1251 |
15.5.2019 |
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13.5.2019 |
Pradaxa |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/08/442 |
15.5.2019 |
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13.5.2019 |
Ratiograstim |
ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland |
EU/1/08/444 |
15.5.2019 |
|
13.5.2019 |
Revlimid |
Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland |
EU/1/07/391 |
15.5.2019 |
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13.5.2019 |
Tevagrastim |
Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland |
EU/1/08/445 |
15.5.2019 |
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16.5.2019 |
Pemetrexed medac |
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland |
EU/1/15/1038 |
20.5.2019 |
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16.5.2019 |
Xeplion |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/11/672 |
20.5.2019 |
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20.5.2019 |
Bondronat |
Atnahs Pharma Netherlands B.V. Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland |
EU/1/96/012 |
22.5.2019 |
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20.5.2019 |
Epclusa |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/16/1116 |
22.5.2019 |
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20.5.2019 |
Kuvan |
BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland |
EU/1/08/481 |
22.5.2019 |
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20.5.2019 |
TachoSil |
Takeda Austria GmbH St.-Peter-Strasse 25, 4020 Linz, Österreich |
EU/1/04/277 |
22.5.2019 |
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22.5.2019 |
Adenuric |
Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg |
EU/1/08/447 |
27.5.2019 |
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22.5.2019 |
Blitzima |
Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |
EU/1/17/1205 |
27.5.2019 |
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22.5.2019 |
Bonviva |
Atnahs Pharma Netherlands B.V. Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland |
EU/1/03/265 |
28.5.2019 |
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22.5.2019 |
Competact |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/06/354 |
27.5.2019 |
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22.5.2019 |
Erbitux |
Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |
EU/1/04/281 |
27.5.2019 |
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22.5.2019 |
KEYTRUDA |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/15/1024 |
27.5.2019 |
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22.5.2019 |
Tyverb |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/07/440 |
27.5.2019 |
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27.5.2019 |
Opdivo |
Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |
EU/1/15/1014 |
29.5.2019 |
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27.5.2019 |
Tafinlar |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/13/865 |
29.5.2019 |
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27.5.2019 |
Tandemact |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/06/366 |
29.5.2019 |
|
27.5.2019 |
Trisenox |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/02/204 |
29.5.2019 |
|
27.5.2019 |
Xeloda |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/00/163 |
29.5.2019 |
|
27.5.2019 |
Xermelo |
Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |
EU/1/17/1224 |
29.5.2019 |
|
— |
Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
|
13.5.2019 |
Nonafact |
Sanquin Plasma Products B.V. Plesmanlaan 125, 1066 CX Amsterdam, Nederland |
EU/1/01/186 |
15.5.2019 |
|
— |
Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
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Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
|
20.5.2019 |
Afoxolaner MERIAL |
afoxolaner |
Merial 29 avenue Tony Garnier, 69007 Lyon, France |
EU/2/19/240 |
Chewable tablet |
QP53BE01 |
22.5.2019 |
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20.5.2019 |
Baycox Iron |
toltrazuril/gleptoferron |
Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland |
EU/2/19/239 |
Suspension for injection |
QP51AJ51 |
22.5.2019 |
|
— |
Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected |
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
|
13.5.2019 |
Horse Allo 20 |
Centauri Biotech SL Calle Asunción SN - 1oIzq (Meicende — Arteixo), 15142 A Coruña, España |
— |
15.5.2019 |
|
— |
Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorisation |
Number of the entry in the Community Register |
Date of notification |
|
13.5.2019 |
Cortavance |
VIRBAC S.A. 1ère Avenue - 2065 m — L.I.D., 06516 Carros Cedex, France |
EU/2/06/069 |
15.5.2019 |
|
27.5.2019 |
Innovax-ND-IBD |
Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/17/213 |
29.5.2019 |
|
27.5.2019 |
VEPURED |
Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España |
EU/2/17/214 |
29.5.2019 |
|
29.5.2019 |
Suvaxyn PCV |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/09/099 |
4.6.2019 |
|
29.5.2019 |
Versican Plus Pi/L4R |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/14/173 |
4.6.2019 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
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European Medicines Agency |
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Domenico Scarlattilaan 6 |
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1083 HS Amsterdam |
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The Netherlands |
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
|
28.6.2019 |
EN |
Official Journal of the European Union |
C 218/8 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2019 to 31 May 2019
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
(2019/C 218/02)
|
— |
Issuing, maintenance or modification of a national marketing authorisation |
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Date of the decision |
Name(s) of the medicinal product |
INN (International Non-Proprietary Name) |
Holder(s) of the marketing authorisation |
Member State concerned |
Date of notification |
|
20.5.2019 |
Closantel inj 50 mg |
closantel |
See Annex I |
See Annex I |
21.5.2019 |
|
16.5.2019 |
Syner-Kinase and associated names |
urokinase |
See Annex II |
See Annex II |
17.5.2019 |
|
27.5.2019 |
Septanest and associated names |
articaine (hydrochloride)/adrenaline (tartrate) |
See Annex III |
See Annex III |
28.5.2019 |
ANNEX I
List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, route of administration and marketing authorisation holders in the Member States
|
Member State EU/EEA |
Marketing authorisation holder |
Name |
INN |
Strength |
Pharmaceutical form |
Animal species |
Route of administration |
|
Bulgaria |
KRKA d.d. Šmarješka cesta 6 Novo mesto 8501 Slovenia |
Сантиола 50 mg/ml инжекционен разтвор за говеда и овце |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Bulgaria |
Industrial Veterinaria, S.A Esmeralda 19 Esplugues de Llobregat Barcelona 08950 Spain |
Роленол |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Croatia |
KRKA d.d. Šmarješka cesta 6 Novo mesto 8501 Slovenia |
Santiola, 50 mg/mL, otopina za injekciju, za goveda i ovce |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Czech Republic |
KRKA d.d. Šmarješka cesta 6 Novo mesto 8501 Slovenia |
Santiola 50 mg/ml injekční roztok pro skot a ovce |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Denmark |
KRKA d.d. Šmarješka cesta 6 Novo mesto 8501 Slovenia |
Santiola Vet |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Estonia |
KRKA d.d. Šmarješka cesta 6 Novo mesto 8501 Slovenia |
Santiola |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
France |
LILLY France 24 Boulevard Vital Bouhot 92200 Neuilly Sur Seine France |
FLUKIVER |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Hungary |
KRKA d.d. Šmarješka cesta 6 Novo mesto 8501 Slovenia |
Santiola 50 mg/ml oldatos injekció szarvasmarhák és juhok részére A.U.V. |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Ireland |
KRKA d.d. Šmarješka cesta 6 Novo mesto 8501 Slovenia |
Santiola 50 mg/ml solution for injection for cattle and sheep |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Latvia |
KRKA d.d. Šmarješka cesta 6 Novo mesto 8501 Slovenia |
Santiola |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Lithuania |
KRKA d.d. Šmarješka cesta 6 Novo mesto 8501 Slovenia |
Santiola 50 mg/ml injekcinis tirpalas galvijams ir avims |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Romania |
KRKA d.d. Šmarješka cesta 6 Novo mesto 8501 Slovenia |
Santiola 50 mg/ml raztopina za injiciranje za govedo in ovce |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Slovenia |
KRKA d.d. Šmarješka cesta 6 Novo mesto 8501 Slovenia |
Santiola 50 mg/ml raztopina za injiciranje za govedo in ovce |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Spain |
Laboratorios e Industrias Iven, S.A. Luis I, 56. Poligono Industrial Vallecas 28031 Madrid Spain |
Endoectiven |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Spain |
CENAVISA, S.L. Cami Pedra Estela s/n Reus (Tarragona) 43205 Spain |
TELCEN |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Spain |
S.P. VETERINARIA, S.A. Ctra. Reus-Vinyols, KM.4,1 Riudoms (Tarragona) 43330 Spain |
ENDOEX 50 mg/ml SOLUCION INYECTABLE |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Spain |
Industrial Veterinaria, S.A Esmeralda 19 Esplugues de Llobregat Barcelona 08950 Spain |
ROLENOL |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
Sweden |
KRKA d.d. Šmarješka cesta 6 Novo mesto 8501 Slovenia |
Santiola vet. |
Closantel |
50 mg/ml |
solution for injection |
cattle, sheep |
sheep: subcutaneous |
|
United Kingdom |
KRKA d.d. Šmarješka cesta 6 Novo mesto 8501 Slovenia |
Santiola 50 mg/ml Solution for Injection for Cattle and Sheep |
Closantel |
50 mg/ml |
solution for injection |
sheep |
sheep: subcutaneous |
ANNEX II
List of medicinal products and presentations
|
Member State EU/EEA |
Marketing authorisation holder |
Applicant |
(Invented) Name |
Strength |
Pharmaceutical form |
Route of administration |
|
France |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
10,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
France |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
25,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
France |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
100,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
France |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
250,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
France |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
500,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
Germany |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
10,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
Germany |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
25,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
Germany |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
100,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
Germany |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
250,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
Germany |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
500,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
The Netherlands |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Urokinase Devrimed 10.000 IE, poeder voor oplossing voor injectie/infusie |
10,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
The Netherlands |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Urokinase Devrimed 25.000 IE, poeder voor oplossing voor injectie/infusie |
25,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
The Netherlands |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Urokinase Devrimed 100.000 IE, poeder voor oplossing voor injectie/infusie |
100,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
The Netherlands |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Urokinase Devrimed 250.000 IE, poeder voor oplossing voor injectie/infusie |
250,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
The Netherlands |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Urokinase Devrimed 500.000 IE, poeder voor oplossing voor injectie/infusie |
500,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
Spain |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
10,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
Spain |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
25,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
Spain |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
100,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
Spain |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
250,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
Spain |
|
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
Syner-KINASE |
500,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
United Kingdom |
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
|
Syner-KINASE |
10,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
United Kingdom |
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
|
Syner-KINASE |
25,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
United Kingdom |
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
|
Syner-KINASE |
100,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
United Kingdom |
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
|
Syner-KINASE |
250,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
|
United Kingdom |
Syner-Medica Ltd Syner-Med House, 120 High Street, Purley, Surrey, CR8 2AD, United Kingdom |
|
Syner-KINASE |
500,000 IU |
Powder for solution for injection/infusion |
Intravenous Use |
ANNEX III
List of medicinal products and presentations
|
Member State EU/EEA |
Marketing Authorisation Holder |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
Content (concentration) |
||||
|
Austria |
|
Septanest mit Epinephrin 1:200 000 |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Submucosal use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Austria |
|
Septanest mit Epinephrin 1:100 000 |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Submucosal use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Belgium |
|
Septanest Normal |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Dental use Submucosal use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Belgium |
|
Septanest Special |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Dental use Submucosal use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Bulgaria |
|
Септанест с Адреналин 1/200 000 |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Dental use Submucosal use |
Articaine hydrochloride 40 mg/ml Epinephrine 0,005 mg/ml |
||||
|
Bulgaria |
|
Септанест с Адреналин 1/100 000 |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Dental use Submucosal use |
Articaine hydrochloride 40 mg/ml Epinephrine 0,01 mg/ml |
||||
|
Croatia |
|
Septanest |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Croatia |
|
Septanest Forte |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Cyprus |
|
Septanest |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Cyprus |
|
Septanest Forte |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Czech Republic |
|
Septanest s adrenalinem 1:200 000 |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Czech Republic |
|
Septanest s adrenalinem 1:100 000 |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Denmark |
|
Septanest |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Denmark |
|
Septocaine |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Estonia |
|
Septanest |
40 mg/ml + 0,005 mg/ml |
Solution for injection in cartridge |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Estonia |
|
Septanest Forte |
40 mg/ml + 0,01 mg/ml |
Solution for injection in cartridge |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Finland |
|
Septocaine |
40 mg/ml + 5 microg/ml |
Solution for injection |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 5 microg/ml |
||||
|
Finland |
|
Septocaine Forte |
40 mg/ml + 10 microg/ml |
Solution for injection |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 10 microg/ml |
||||
|
France |
|
Septanest 40 mg/ml Adrenalinée au 1/200 000 , solution injectable à usage dentaire |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Local or regional injection intra-oral Submucosal use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml adrénaline (tartrate d’): non précisé |
||||
|
France |
|
Chlorhydrate d’Articaïne Septodont 40 mg/ml Adrénaline 1/200 000 , solution injectable |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Dental use Infiltration and perineural use in the oral cavity |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml adrénaline (tartrate d’): non précisé |
||||
|
France |
|
Septanest 40 mg/ml Adrenalinée au 1/100 000 , solution injectable à usage dentaire |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Local or regional injection intra-oral Submucosal use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml adrénaline (tartrate d’): non précisé |
||||
|
France |
|
Chlorhydrate d’Articaïne Septodont 40 mg/ml Adrénaline 1/100 000 , solution injectable |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Dental use Infiltration and perineural use in the oral cavity |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml adrénaline (tartrate d’): non précisé |
||||
|
Germany |
|
Septanest mit Epinephrin 1:200 000 - 40 mg/ml + 0,005 mg/ml Injektionslösung |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Epinephrine 0,005 mg/ml |
||||
|
Germany |
|
Septanest mit Adrenalin 1/200 000 |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Submucosal use |
Articaine hydrochloride 40 mg/ml Epinephrine 0,005 mg/ml |
||||
|
Germany |
|
Septanest mit Epinephrin 1:100 000 - 40 mg/ml + 0,01 mg/ml Injektionslösung |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Epinephrine 0,01 mg/ml |
||||
|
Germany |
|
Septanest mit Adrenalin 1/100 000 |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Submucosal use |
Articaine hydrochloride 40 mg/ml Epinephrine 0,01 mg/ml |
||||
|
Greece |
|
Septanest Ενέσιμο διάλυμα 4 % + 1:200 000 |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Infiltration Periodontal use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Greece |
|
Septanest Ενέσιμο διάλυμα 4 % + 1:100 000 |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Infiltration Periodontal use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Hungary |
|
Septanest |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Submucosal use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Italy |
|
Septanest |
40 mg/ml + 0,005 mg/ml |
Solution for injection in cartridge |
Infiltration |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Italy |
|
Septanest |
40 mg/ml + 0,01 mg/ml |
Solution for injection in cartridge |
Infiltration |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Latvia |
|
Septanest 40 mg/5 mikrogrami/ml šķīdums injekcijām kārtridžā |
40 mg/ml + 0,005 mg/ml |
Solution for injection in cartridge |
Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Latvia |
|
Septanest Forte 40 mg/10 mikrogrami/ml šķīdums injekcijām kārtridžā |
40 mg/ml + 0,01 mg/ml |
Solution for injection in cartridge |
Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Lithuania |
|
Septanest |
40 mg/ml + 0,005 mg/ml |
Solution for injection in cartridge |
Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Lithuania |
|
Septanest Forte |
40 mg/ml + 0,01 mg/ml |
Solution for injection in cartridge |
Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Luxembourg |
|
Septanest-N 1*200.000 |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Dental use Submucosal use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Luxembourg |
|
Septanest Adrenaline 1:100 000 |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Dental use Submucosal use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Malta |
|
Septanest with adrenaline 1/200 000 |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Malta |
|
Septanest with adrenaline 1/100 000 |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Netherlands |
|
Septanest N |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Netherlands |
|
Septanest SP |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Norway |
|
Septocaine |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Dental use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Norway |
|
Septocaine Forte |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Dental use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Poland |
|
Septanest Z Adrenaliną 1: 200 000 |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Poland |
|
Septanest Z Adrenaliną 1: 100 000 |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Portugal |
|
Septanest 1/200 000 |
68 mg/1.7 ml + 0.015 mg/1.7 ml |
Solução injetável |
Via bucal |
Articaína, cloridrato 40 mg/ml Adrenalina, tartarato 0,0091 mg/ml |
||||
|
Portugal |
|
Septanest 1/100 000 |
68 mg/1.7 ml + 0.031 mg/1.7 ml |
Solução injetável |
Via bucal |
Articaína, cloridrato 40 mg/ml Adrenalina, tartarato 0,0182 mg/ml |
||||
|
Romania |
|
Septanest Cu Adrenalină 1/200 000 |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Dental use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Romania |
|
Septanest Cu Adrenalină 1/100 000 |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Dental use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Slovak Republic |
|
Septanest |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Slovak Republic |
|
Septanest Forte |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Slovenia |
|
Septanestepi 40 mg/0,005 mg v 1 ml raztopina za injiciranje |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Dental use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Slovenia |
|
Septanestepi 40 mg/0,01 mg v 1 ml raztopina za injiciranje |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Dental use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |
||||
|
Spain |
|
Septanest con adrenalina 1/200 000 |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline bitartrate 0,005 mg/ml |
||||
|
Spain |
|
Septanest con adrenalina 1/100 000 |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline bitartrate 0,01 mg/ml |
||||
|
Sweden |
|
Septocaine |
40 mg/ml + 0,005 mg/ml |
Solution for injection |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,005 mg/ml |
||||
|
Sweden |
|
Septocaine Forte |
40 mg/ml + 0,01 mg/ml |
Solution for injection |
Dental use Infiltration and perineural use |
Articaine hydrochloride 40 mg/ml Adrenaline 0,01 mg/ml |