EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document C:2022:496:FULL
Official Journal of the European Union, C 496, 29 December 2022
Official Journal of the European Union, C 496, 29 December 2022
Official Journal of the European Union, C 496, 29 December 2022
ISSN 1977-091X |
||
Official Journal of the European Union |
C 496 |
|
![]() |
||
English edition |
Information and Notices |
Volume 65 |
Contents |
page |
|
|
IV Notices |
|
|
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
|
|
European Commission |
|
2022/C 496/01 |
||
2022/C 496/02 |
EN |
|
IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
29.12.2022 |
EN |
Official Journal of the European Union |
C 496/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2022 to 30 November 2022
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (2))
(2022/C 496/01)
— 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 |
||
7.11.2022 |
Melatonin Neurim |
melatonin |
|
EU/1/22/1694 |
Prolonged-release tablet |
N05CH01 |
8.11.2022 |
||
9.11.2022 |
LIVTENCITY |
maribavir |
|
EU/1/22/1672 |
Film-coated tablet |
J05AX10 |
10.11.2022 |
||
9.11.2022 |
Pyrukynd |
mitapivat |
|
EU/1/22/1662 |
Film-coated tablet |
B06AX04 |
10.11.2022 |
||
9.11.2022 |
Rubraca |
rucaparib |
|
EU/1/17/1250 |
Film-coated tablet |
L01XK03 |
10.11.2022 |
||
9.11.2022 |
Sorafenib Accord |
sorafenib |
|
EU/1/22/1696 |
Film-coated tablet |
L01EX02 |
10.11.2022 |
||
9.11.2022 |
Teriflunomide Accord |
teriflunomide |
|
EU/1/22/1693 |
Film-coated tablet |
L04AA31 |
10.11.2022 |
||
9.11.2022 |
Teriflunomide Mylan |
teriflunomide |
|
EU/1/22/1698 |
Film-coated tablet |
L04AA31 |
10.11.2022 |
||
9.11.2022 |
Ximluci |
ranibizumab |
|
EU/1/22/1691 |
Solution for injection |
S01LA04 |
11.11.2022 |
||
15.11.2022 |
Enjaymo |
sutimlimab |
|
EU/1/22/1687 |
Solution for infusion |
L04AA55 |
23.11.2022 |
||
18.11.2022 |
Teriparatide SUN |
teriparatide |
|
EU/1/22/1697 |
Solution for injection |
H05AA02 |
22.11.2022 |
||
28.11.2022 |
Caprelsa |
vandetanib |
|
EU/1/11/749 |
Film-coated tablet |
L01EX04 |
30.11.2022 |
— 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 |
||
7.11.2022 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka |
|
EU/1/17/1263 |
9.11.2022 |
||
7.11.2022 |
EXPAREL liposomal |
|
EU/1/20/1489 |
9.11.2022 |
||
9.11.2022 |
Aclasta |
|
EU/1/05/308 |
11.11.2022 |
||
9.11.2022 |
Adempas |
|
EU/1/13/907 |
10.11.2022 |
||
9.11.2022 |
ADYNOVI |
|
EU/1/17/1247 |
10.11.2022 |
||
9.11.2022 |
Alkindi |
|
EU/1/17/1260 |
10.11.2022 |
||
9.11.2022 |
Darunavir Krka |
|
EU/1/17/1249 |
15.11.2022 |
||
9.11.2022 |
Dexmedetomidine Accord |
|
EU/1/19/1418 |
10.11.2022 |
||
9.11.2022 |
Elaprase |
|
EU/1/06/365 |
10.11.2022 |
||
9.11.2022 |
Eylea |
|
EU/1/12/797 |
10.11.2022 |
||
9.11.2022 |
GHRYVELIN |
|
EU/1/18/1337 |
16.11.2022 |
||
9.11.2022 |
Hycamtin |
|
EU/1/96/027 |
11.11.2022 |
||
9.11.2022 |
Incruse Ellipta |
|
EU/1/14/922 |
10.11.2022 |
||
9.11.2022 |
Isturisa |
|
EU/1/19/1407 |
10.11.2022 |
||
9.11.2022 |
Kentera |
|
EU/1/03/270 |
14.11.2022 |
||
9.11.2022 |
Laventair Ellipta |
|
EU/1/14/899 |
10.11.2022 |
||
9.11.2022 |
Lucentis |
|
EU/1/06/374 |
11.11.2022 |
||
9.11.2022 |
Memantine ratiopharm |
|
EU/1/13/836 |
11.11.2022 |
||
9.11.2022 |
Rilutek |
|
EU/1/96/010 |
14.11.2022 |
||
9.11.2022 |
Rolufta Ellipta |
|
EU/1/17/1174 |
14.11.2022 |
||
9.11.2022 |
Segluromet |
|
EU/1/18/1265 |
11.11.2022 |
||
9.11.2022 |
Stelara |
|
EU/1/08/494 |
10.11.2022 |
||
9.11.2022 |
Stocrin |
|
EU/1/99/111 |
11.11.2022 |
||
9.11.2022 |
Talzenna |
|
EU/1/19/1377 |
10.11.2022 |
||
9.11.2022 |
Torisel |
|
EU/1/07/424 |
10.11.2022 |
||
9.11.2022 |
Vargatef |
|
EU/1/14/954 |
10.11.2022 |
||
9.11.2022 |
Vyndaqel |
|
EU/1/11/717 |
10.11.2022 |
||
10.11.2022 |
Comirnaty |
|
EU/1/20/1528 |
11.11.2022 |
||
10.11.2022 |
Spikevax |
|
EU/1/20/1507 |
11.11.2022 |
||
11.11.2022 |
JCOVDEN |
|
EU/1/20/1525 |
14.11.2022 |
||
15.11.2022 |
Brukinsa |
|
EU/1/21/1576 |
16.11.2022 |
||
15.11.2022 |
Caprelsa |
|
EU/1/11/749 |
18.11.2022 |
||
15.11.2022 |
IMBRUVICA |
|
EU/1/14/945 |
16.11.2022 |
||
15.11.2022 |
Lamivudine Teva |
|
EU/1/09/566 |
21.11.2022 |
||
15.11.2022 |
Mylotarg |
|
EU/1/18/1277 |
16.11.2022 |
||
15.11.2022 |
Riluzole Zentiva |
|
EU/1/12/768 |
18.11.2022 |
||
15.11.2022 |
Steglatro |
|
EU/1/18/1267 |
17.11.2022 |
||
15.11.2022 |
Tecartus |
|
EU/1/20/1492 |
22.11.2022 |
||
15.11.2022 |
Xevudy |
|
EU/1/21/1562 |
16.11.2022 |
||
18.11.2022 |
Anoro Ellipta |
|
EU/1/14/898 |
22.11.2022 |
||
18.11.2022 |
Aripiprazole Accord |
|
EU/1/15/1045 |
22.11.2022 |
||
18.11.2022 |
Byfavo |
|
EU/1/20/1505 |
22.11.2022 |
||
18.11.2022 |
Fasturtec |
|
EU/1/00/170 |
22.11.2022 |
||
18.11.2022 |
Kevzara |
|
EU/1/17/1196 |
22.11.2022 |
||
18.11.2022 |
Latuda |
|
EU/1/14/913 |
22.11.2022 |
||
18.11.2022 |
LIBTAYO |
|
EU/1/19/1376 |
21.11.2022 |
||
18.11.2022 |
Lyumjev |
|
EU/1/20/1422 |
22.11.2022 |
||
18.11.2022 |
Matever |
|
EU/1/11/711 |
22.11.2022 |
||
18.11.2022 |
Methylthioninium chloride Proveblue |
|
EU/1/11/682 |
23.11.2022 |
||
18.11.2022 |
Vaborem |
|
EU/1/18/1334 |
23.11.2022 |
||
18.11.2022 |
Yselty |
|
EU/1/21/1606 |
23.11.2022 |
||
18.11.2022 |
Zeposia |
|
EU/1/20/1442 |
21.11.2022 |
||
21.11.2022 |
Aldara |
|
EU/1/98/080 |
22.11.2022 |
||
21.11.2022 |
Anagrelide Mylan |
|
EU/1/17/1256 |
22.11.2022 |
||
21.11.2022 |
AUBAGIO |
|
EU/1/13/838 |
22.11.2022 |
||
21.11.2022 |
Biktarvy |
|
EU/1/18/1289 |
22.11.2022 |
||
21.11.2022 |
Eucreas |
|
EU/1/07/425 |
22.11.2022 |
||
21.11.2022 |
Imatinib Teva |
|
EU/1/12/808 |
22.11.2022 |
||
21.11.2022 |
Jylamvo |
|
EU/1/17/1172 |
24.11.2022 |
||
21.11.2022 |
Lumykras |
|
EU/1/21/1603 |
23.11.2022 |
||
21.11.2022 |
Multaq |
|
EU/1/09/591 |
22.11.2022 |
||
21.11.2022 |
Obiltoxaximab SFL |
|
EU/1/20/1485 |
28.11.2022 |
||
21.11.2022 |
Qtern |
|
EU/1/16/1108 |
22.11.2022 |
||
21.11.2022 |
Skyrizi |
|
EU/1/19/1361 |
22.11.2022 |
||
21.11.2022 |
Tasmar |
|
EU/1/97/044 |
22.11.2022 |
||
21.11.2022 |
Veklury |
|
EU/1/20/1459 |
21.11.2022 |
||
21.11.2022 |
Voncento |
|
EU/1/13/857 |
22.11.2022 |
||
21.11.2022 |
ZALTRAP |
|
EU/1/12/814 |
22.11.2022 |
||
25.11.2022 |
COVID-19 Vaccine (inactivated, adjuvanted) Valneva |
|
EU/1/21/1624 |
25.11.2022 |
||
28.11.2022 |
Adenuric |
|
EU/1/08/447 |
29.11.2022 |
||
28.11.2022 |
Beromun |
|
EU/1/99/097 |
29.11.2022 |
||
28.11.2022 |
Deferasirox Mylan |
|
EU/1/19/1386 |
29.11.2022 |
||
28.11.2022 |
Dengvaxia |
|
EU/1/18/1338 |
29.11.2022 |
||
28.11.2022 |
Dimethyl fumarate Polpharma |
|
EU/1/22/1635 |
2.12.2022 |
||
28.11.2022 |
Docetaxel Accord |
|
EU/1/12/769 |
30.11.2022 |
||
28.11.2022 |
IKERVIS |
|
EU/1/15/990 |
30.11.2022 |
||
28.11.2022 |
Kivexa |
|
EU/1/04/298 |
30.11.2022 |
||
28.11.2022 |
Mircera |
|
EU/1/07/400 |
30.11.2022 |
||
28.11.2022 |
Nityr |
|
EU/1/18/1290 |
29.11.2022 |
||
28.11.2022 |
Nordimet |
|
EU/1/16/1124 |
29.11.2022 |
||
28.11.2022 |
Olanzapine Mylan |
|
EU/1/08/475 |
29.11.2022 |
||
28.11.2022 |
Onpattro |
|
EU/1/18/1320 |
2.12.2022 |
||
28.11.2022 |
Paxlovid |
|
EU/1/22/1625 |
28.11.2022 |
||
28.11.2022 |
Pegasys |
|
EU/1/02/221 |
29.11.2022 |
||
28.11.2022 |
Potactasol |
|
EU/1/10/660 |
29.11.2022 |
||
28.11.2022 |
Praluent |
|
EU/1/15/1031 |
29.11.2022 |
||
28.11.2022 |
Sixmo |
|
EU/1/19/1369 |
29.11.2022 |
||
28.11.2022 |
Stivarga |
|
EU/1/13/858 |
29.11.2022 |
||
28.11.2022 |
Taltz |
|
EU/1/15/1085 |
2.12.2022 |
||
28.11.2022 |
Zessly |
|
EU/1/18/1280 |
29.11.2022 |
||
28.11.2022 |
Zoely |
|
EU/1/11/690 |
6.12.2022 |
— Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
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 |
||
18.11.2022 |
Hepsera |
|
EU/1/03/251 |
22.11.2022 |
— Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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 |
||
22.11.2022 |
Mometamax Ultra |
gentamicin, posaconazole, mometasone furoate |
|
EU/2/22/289 |
Ear drops, suspension |
Pending |
24.11.2022 |
||
30.11.2022 |
DogStem |
equine umbilical cord mesenchymal stem cells |
|
EU/2/22/285 |
Suspension for injection |
QM09AX90 |
1.12.2022 |
— Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 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 |
||
9.11.2022 |
BROADLINE |
|
EU/2/13/157 |
11.11.2022 |
||
9.11.2022 |
Purevax RCPCh FeLV |
|
EU/2/04/047 |
10.11.2022 |
||
9.11.2022 |
Zuprevo |
|
EU/2/11/124 |
10.11.2022 |
||
11.11.2022 |
Bravecto Plus |
|
EU/2/18/224 |
15.11.2022 |
||
11.11.2022 |
Librela |
|
EU/2/20/261 |
14.11.2022 |
||
11.11.2022 |
Rheumocam |
|
EU/2/07/078 |
15.11.2022 |
||
11.11.2022 |
Simparica |
|
EU/2/15/191 |
15.11.2022 |
||
18.11.2022 |
Bravecto Plus |
|
EU/2/18/224 |
21.11.2022 |
||
18.11.2022 |
CircoMax Myco |
|
EU/2/20/264 |
22.11.2022 |
||
18.11.2022 |
MiPet Easecto |
|
EU/2/17/220 |
21.11.2022 |
||
30.11.2022 |
Arti-Cell Forte |
|
EU/2/18/228 |
1.12.2022 |
||
30.11.2022 |
CircoMax |
|
EU/2/21/281 |
1.12.2022 |
||
30.11.2022 |
Meloxoral |
|
EU/2/10/111 |
1.12.2022 |
||
30.11.2022 |
ProZinc |
|
EU/2/13/152 |
8.12.2022 |
||
30.11.2022 |
Simparica Trio |
|
EU/2/19/243 |
2.12.2022 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
European Medicines Agency |
Domenico Scarlattilaan 6 |
1083 HS Amsterdam |
NETHERLANDS |
29.12.2022 |
EN |
Official Journal of the European Union |
C 496/12 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2022 to 30 November 2022
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1), Article 38 of Directive 2001/82/EC (2) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (3))
(2022/C 496/02)
— |
Issuing, maintenance or modification of a national marketing authorisation |
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 |
9.11.2022 |
Toltrazuril oral 25 mg/ml for chickens |
Toltrazuril |
See Annex I |
See Annex I |
10.11.2022 |
28.11.2022 |
Synchron Research Services |
Synchron Research Services |
See Annex II |
See Annex II |
28.11.2022 |
— Suspension of a national marketing authorisation
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 |
28.11.2022 |
Synchron Research Services |
Synchron Research Services |
See Annex II |
See Annex II |
28.11.2022 |
(1) OJ L 311, 28.11.2001, p. 67.
ANNEX I
List of the names, pharmaceutical forms, strength of the veterinary medicinal products, animal species, routes of administration, marketing authorisation holders in the Member States
Member State EU/EEA |
Marketing authorisation holders |
Name |
INN |
Strength |
Pharmaceutical form |
Animal species |
Route of administration |
Austria |
Laboratorios Calier, S.A. Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Vallès (Barcelona) Spain |
Zuritol 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Austria |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox Direct 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Belgium |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 25mg/ml, solution pour administration dans l’eau de boisson pour poulets et dindes / oplossing voor gebruik in drinkwater voor kippen en kalkoenen toltrazuril / Lösung zum Eingeben über das Trinkwasser für Hühner und Puten |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Belgium |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 2,5 % 25 mg/ml, solution buvable / drank / Lösung zum Einnehmen |
Toltrazuril |
25 mg/ml |
Oral solution |
Chicken, turkey |
Oral use |
Belgium |
Avimedical B.V. Abbinkdijk 1, 7255 LX Hengelo Gld The Netherlands |
Coccinox |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Belgium |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Bulgaria |
Pharma Vet Ltd Shumen, ul. ‘Otec Paisij’ № 40, Bulgaria |
Фармакокс разтвор Pharmacox liquid |
Toltrazuril |
2.5 g/ 100 ml |
Oral solution |
Chicken, turkey |
Oral use |
Bulgaria |
Interchemie Werken De Adelaar BV Metaalweg 8, 5804 CG Venray, The Netherlands |
Intracox oral |
Toltrazuril |
25 mg/ml |
Oral solution |
Chicken, turkey |
Oral use |
Bulgaria |
Kepro B.V. Maagdenburgstraat 17, 7421 ZA Deventer The Netherlands |
Кепкокс 2.5 % орал /Kepcox 2.5 % oral |
Toltrazuril |
25 mg/ml |
Oral solution |
Chicken, turkey |
Oral use |
Bulgaria |
Ceva Santé Animale 10, Av. de La Ballastière 33500 Libourne France |
Севазурил/Cevazuril |
Toltrazuril |
25 mg/ml |
Oral solution |
Broilers, growing parents of chickens, bright, turkeys |
Oral use |
Bulgaria |
Bayer Animal Health 51368 Leverkusen, Germany |
Байкокс 2,5 % разтвор/Baycox 2,5 % solution |
Toltrazuril |
25 mg/ml |
Oral solution |
Chicken, turkey |
Oral use |
Bulgaria |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril 25 mg/ml разтвор за перорална употреба с питейната вода при пилета / Dozuril 25 mg/ml solution for use in drinking water for chicken |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Croatia |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 25 mg/ml, otopina za primjenu u vodi za piće, za kokoši i purane |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Cyprus |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 2,5 % w/v Πόσιμο διάλυμα για ορνίθια κρεοπαραγωγής και ινδορνίθια. |
Toltrazuril |
25 mg/ml |
Oral solution |
Broiler, turkey |
Oral use |
Czech Republic |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 2,5 % (w/v) perorální roztok |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (broiler), turkey |
Oral use |
Denmark |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Estonia |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Estonia |
Interchemie Werken De Adelaar Eesti AS Vanapere tee 14, Puunsi Village, Viimsi Rural Municipality, Harju County, 74013 Estonia |
Intracox Oral |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (broilers, pullets, breeders), turkey |
Oral use |
Estonia |
Laboratorios Calier, S.A. Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Vallès (Barcelona) Spain |
Zuritol |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
France |
Ceva Santé Animale 10, Av. de La Ballastière 33500 Libourne France |
Cevazuril 25 mg/ml solution buvable pour poulets de chair, poulettes et reproducteurs |
Toltrazuril |
25 mg/ml |
Oral solution |
Chicken (broilers, pullets, breeders) |
Oral use |
France |
Virbac 1ere avenue, 2065 m, LID, 06516 Carros, France |
Toltracox 2,5 % |
Toltrazuril |
25 mg/ml |
Oral solution |
Chicken (broilers, pullets, breeders) |
Oral use |
France |
Laboratorios Calier, S.A. Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Vallès (Barcelona) Spain |
Zuritol 25 mg/ml solution buvable pour poulets |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
France |
VetPharma Animal Health S.L. Les Corts 23, 08028 Barcelona, Spain |
Zorabel 25 mg/ml solution pour administration dans l'eau de boisson pour poulets et dindes |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders), turkey |
Oral use |
France |
Elanco GmbH Heinz-Lohmann-Straße 4 27472 Cuxhaven Germany |
Baycox 25 mg/ml solution pour administration dans l'eau de boisson des poules et des dindes |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (broilers, pullets, breeders), turkey |
Oral use |
France |
Avimedical B.V. Abbinkdijk 1, 7255 LX Hengelo Gld The Netherlands |
Coccinox 25 mg/ml solution orale pour administration dans l'eau de boisson pour poulets et dindes |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (broilers, pullets, breeders), turkey, pigeon |
Oral use |
France |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Cozuril CT 25 mg/ml solution pour administration dans l'eau de boisson pour poulets et dindes |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders), turkey |
Oral use |
Germany |
VetPharma Animal Health S.L. Les Corts 23, 08028 Barcelona, Spain |
Zorabel 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Germany |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril CT |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders), turkey |
Oral use |
Germany |
Laboratorios Calier, S.A. Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Vallès (Barcelona) Spain |
Zuritol 25 mg/ml Lösung zum Eingeben über das Trinkwasser |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Germany |
Elanco GmbH Heinz-Lohmann-Straße 4 27472 Cuxhaven Germany |
Baycox 25 mg/ml, Lösung zum Eingeben über das Trinkwasser für Hühner und Puten |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Germany |
Laboratorios Karizoo, S.A. Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui, 08140 Barcelona Spain |
Toltra-K 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Germany |
Bremer Pharma GmbH, Werkstr. 42, D-34414 Warburg, Scherfede, Germany |
Bremacox 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner und Puten |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders), turkey |
Oral use |
Germany |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril 25 mg/ml Lösung zum Eingeben über das Trinkwasser für Hühner |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Greece |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 2,5 % |
Toltrazuril |
25 mg/ml |
Oral solution |
Broiler, turkey |
Oral use |
Greece |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Greece |
VetPharma Animal Health S.L. Les Corts 23, 08028 Barcelona, Spain |
Zorabel |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders), turkey |
Oral use |
Greece |
Laboratorios Calier, S.A. Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Vallès (Barcelona) Spain |
Zuritol, Διάλυμα για χoρήyηση με πόσιμο νερό 25 mg/ml |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Hungary |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 2,5 % koncentrátum belsőleges oldathoz A.U.V. |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Hungary |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril 25 mg/ml, oldat ivóvízbe keveréshez házityúkoknak A.U.V. |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Hungary |
Laboratorios Calier, S.A. Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Vallès (Barcelona) Spain |
Zuritol 25 mg/ml oldat ivóvízbe keveréshez házityúkok részére A.U.V. |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Hungary |
Laboratorios Karizoo, S.A. Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui, 08140 Barcelona Spain |
Toltra-K 25 mg/ml oldat ivóvízbe keveréshez házityúkok és pulykák számára A.U.V. |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Ireland |
Elanco GmbH Heinz-Lohmann-Straße 4 27472 Cuxhaven Germany |
Baycox 25 mg/ml, solution for use in drinking water for chickens and turkeys |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (broilers, pullets, breeders), turkey |
Oral use |
Ireland |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril 25 mg/ml solution for use in drinking water for chickens |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Ireland |
Laboratorios Calier, S.A. Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Vallès (Barcelona) Spain |
Zuritol 25 mg/ml solution for use in drinking water for chickens |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Italy |
Elanco Italia S.p.A Via dei Colatori, 12 50019 Sesto Fiorentino (FI) Italy |
Baycox PT 25 mg/ml soluzione per uso in acqua di bevanda per polli da carne e tacchini |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (broilers, pullets, breeders), turkey |
Oral use |
Italy |
Elanco Italia S.p.A Via dei Colatori, 12 50019 Sesto Fiorentino (FI) Italy |
Baycox Soluzione orale 25 mg/ml per polli da carne e tacchini |
Toltrazuril |
25 mg/ml |
Oral solution |
Broiler, turkey |
Oral use |
Italy |
Ceva Salute Animale S.p.A. Viale Colleoni 15 20864 Agrate Brianza (MB) Italy |
Cevazuril, 25 mg/ml, soluzione orale, per polli da carne e tacchini, da somministrare diluita in acqua da bere. |
Toltrazuril |
25 mg/ml |
Oral solution |
Broiler, turkey |
Oral use |
Italy |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril CT 25 mg/ml, soluzione per l'uso in acqua da bere per polli e tacchini |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders), turkey |
Oral use |
Italy |
Laboratorios Karizoo, S.A. Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui, 08140 Barcelona Spain |
Toltra-K-25 Soluzione da usare nell’acqua di bevanda per polli e tacchini |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders), turkey |
Oral use |
Italy |
Industria Italiana Integratori Trei S.p.A. Viale Corassori, 62 41100 Modena Italy |
Treizuril, 25 mg/ml, soluzione orale per polli da carne e tacchini |
Toltrazuril |
25 mg/ml |
Oral solution |
Broiler, turkey |
Oral use |
Italy |
Laboratorios Calier, S.A. Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Vallès (Barcelona) Spain |
Zuritol 25 mg/ml soluzione per uso in acqua da bere per polli |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Latvia |
Interchemie Werken De Adelaar Eesti AS Vanapere tee 14, Puunsi Village, Viimsi Rural Municipality, Harju County, 74013 Estonia |
LV Intracox Oral 25 mg/ml šķīdums iekšķīgai lietošanai tītariem un vistām |
Toltrazuril |
25 mg/ml |
Oral solution |
Chicken, turkey |
Oral use |
Latvia |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril 25 mg/ml šķīdums lietošanai ar dzeramo ūdeni vistām |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Latvia |
Laboratorios Calier, S.A. Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Vallès (Barcelona) Spain |
Zuritol 25 mg/ml šķīdums lietošanai ar dzeramo ūdeni vistām |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Lithuania |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril 25 mg/ml, tirpalas naudoti su geriamuoju vandeniu vištoms |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Lithuania |
Laboratorios Calier, S.A. Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Vallès (Barcelona) Spain |
Zuritol 25 mg/ml, tirpalas, naudoti su geriamuoju vandeniu vištoms |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Lithuania |
UAB Interchemie werken De Adelaar LT, Terminalo str. 13, Biruliškes, 54469, Kaunas distr. Lithuania |
Intracox oral, 25 mg/ml tirpalas naudoti su ger. vandeniu vištoms ir kalakutams |
Toltrazuril |
25 mg/ml |
Oral solution |
Chicken (broiler), turkey |
Oral use |
Luxembourg |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 25 mg/m, solution pour administration dans l’eau de boisson pour poulets et dindes / Lösung zum Eingeben über das Trinkwasser für Hühner und Puten |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Luxembourg |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 2,5 % 25 mg/ml, solution buvable / Lösung zum Einnehmen |
Toltrazuril |
25 mg/ml |
Oral solution |
Chicken, turkey |
Oral use |
Luxembourg |
Avimedical B.V. Abbinkdijk 1, 7255 LX Hengelo Gld The Netherlands |
Coccinox |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Luxembourg |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Malta |
Kepro B.V. Maagdenburgstraat 17, 7421 ZA Deventer The Netherlands |
Kepcox 2.5 % |
Toltrazuril |
25 mg/ml |
Oral solution |
Chicken (pullets, breeders), turkey |
Oral use |
Netherlands |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 25 mg/ml, oplossing voor gebruik in drinkwater voor kippen en kalkoenen |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (broilers, pullets, breeders), turkey |
Oral use |
Netherlands |
Avimedical B.V. Abbinkdijk 1, 7255 LX Hengelo Gld The Netherlands |
Coccinox 25 mg/ml orale oplossing voor gebruik in drinkwater voor kippen, kalkoenen, duiven en konijnen |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (broilers, pullets, breeders), turkey, pigeon |
Oral use |
Netherlands |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril CT 25 mg/ml oplossing voor toediening in drinkwater voor kippen en kalkoenen |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders), turkey |
Oral use |
Netherlands |
Pantex Holland B.V. Smaragdweg 15 5525 LA Hapert The Netherlands |
Toltrapan 25 mg/ml, oplossing voor gebruik in drinkwater voor kippen en kalkoenen |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (broilers, pullets, breeders), turkey |
Oral use |
Netherlands |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril 25 mg/ml oplossing voor toediening in drinkwater voor kippen |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Poland |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 2,5 %, (2,5 g/100 ml, roztwór doustny dla kur i indyków) |
Toltrazuril |
2.5 g/ 100 ml |
Oral solution |
Chicken (pullets), turkey |
Oral use |
Poland |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Poland |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril CT |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (broilers, pullets, breeders), turkey |
Oral use |
Poland |
Biofaktor Sp. z o. o. Czysta 4 st., 96-100 Skierniewice, Poland |
Endocox |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Poland |
Lovapharm Consulting B.V. Rijsven 3 5645 KH Eindhoven The Netherlands |
Lovacox oral |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (broilers, pullets, breeders), turkey |
Oral use |
Poland |
Laboratorios Karizoo, S.A. Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui, 08140 Barcelona Spain |
Toltra-K |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders), turkey |
Oral use |
Poland |
VetPharma Animal Health S.L. Les Corts 23, 08028 Barcelona, Spain |
Zorabel |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders), turkey |
Oral use |
Poland |
Laboratorios Calier, S.A. Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Vallès (Barcelona) Spain |
Zuritol |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Portugal |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 25 mg/ml, solução para administração na água de bebida para galinhas e perus |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Portugal |
VetPharma Animal Health S.L. Les Corts 23, 08028 Barcelona, Spain |
Zorabel 25 mg/ml solução para administração na água de bebida para galinhas e perus |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Portugal |
Laboratorios Karizoo, S.A. Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui, 08140 Barcelona Spain |
Toltra-K 25 mg/ml solução para administração na água de bebida para galinhas e perus |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
Portugal |
Calier Portugal, S.A. Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro Estrada de Albarraque 2710 — 335 Sintra Portugal |
Zuritol 25 mg/ml solução para administração na água de bebida para galinhas |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Romania |
Ceva Santé Animale 10, Av. de La Ballastière 33500 Libourne France |
Cevazuril |
Toltrazuril |
25 mg/ml |
Oral solution |
Broilers, replacements, pullets, turkeys |
Oral use |
Romania |
Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands |
Dozuril 25 mg/ml |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
Romania |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox |
Toltrazuril |
25 mg/ml |
Oral solution |
Chicken, turkey |
Oral use |
Slovak Republic |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 2,5 % (w/v) perorálny roztok |
Toltrazuril |
25 mg/ml |
Oral solution |
Chicken, turkey |
Oral use |
Slovenia |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 25 mg/ml peroralna raztopina za piščance in purane |
Toltrazuril |
25 mg/ml |
Oral solution |
Chicken, turkey |
Oral use |
Spain |
Bayer Animal Health 51368 Leverkusen, Germany |
Baycox 25 mg/ml solución para administración en agua de bebida para aves |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (broilers, chick for replacement), turkey |
Oral use |
Spain |
Laboratorios Karizoo, S.A. Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui, 08140 Barcelona Spain |
Toltra-K 25 mg/ml solución para administración en agua de bebida para pollos y pavos |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders), turkey |
Oral use |
Spain |
VetPharma Animal Health S.L. Les Corts 23, 08028 Barcelona, Spain |
Zorabel 25 mg/ml solucion para administracion en agua de bebida para pollos y pavos |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders), turkey |
Oral use |
Spain |
Laboratorios Calier, S.A. Barcelonès, 26 (Pla del Ramassà) 08520 Les Franqueses del Vallès (Barcelona) Spain |
Zuritol 25 mg/ml solucion para uso en agua de bebida para pollos |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken (pullets, breeders) |
Oral use |
UK (Northern Ireland) (1) |
Elanco Europe Ltd, Form 2, Bartley Way, Bartley Wood Business Park, Hook, RG 27 9XA, United Kingdom |
Baycox 25 mg/ml, solution for use in drinking water for chickens and turkeys |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
UK (Northern Ireland) (1) |
Laboratorios Karizoo, S.A. Mas Pujades, 11-12, Pol. Ind. La Borda, Caldes de Montbui, 08140 Barcelona Spain |
Toltra-K 25 mg/ml solution for use in drinking water for chickens and turkeys |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
UK (Northern Ireland) (1) |
VetPharma Animal Health S.L. Les Corts 23, 08028 Barcelona, Spain |
Zorabel 25 mg/ml solution for use in drinking water for chickens and turkeys |
Toltrazuril |
25 mg/ml |
Solution for use in drinking water |
Chicken, turkey |
Oral use |
(1) For the United Kingdom, as from 1 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.
ANNEX II
List of nationally authorised medicinal products and marketing authorisation applications
Annex IA. Medicinal products for which the marketing authorisations are recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established or may continue to be assessed by the relevant national competent authorities
Member State EU/EEA |
Marketing Authorisation Holder |
Applicant |
Invented name |
INN |
Strength |
Pharmaceutical form |
Route of administration |
Austria |
Accord Healthcare B.V. |
|
Amlodipin Accord |
Amlodipine |
5 mg |
Tablet |
Oral use |
Austria |
Accord Healthcare B.V. |
|
Amlodipin Accord |
Amlodipine |
10 mg |
Tablet |
Oral use |
Belgium |
Eurogenerics N.V./S.A. |
|
Tramadol/Paracetamol EG 37,5 /325 mg filmomhulde tabletten |
Tramadol/paracetamol |
37,5 mg/325 mg |
Film-coated tablet |
Oral use |
Croatia |
Pliva Hrvatska d.o.o. |
|
Diuver 5 mg tablets |
Torasemide |
5 mg |
tablet |
Oral use |
Croatia |
Pliva Hrvatska d.o.o. |
|
Diuver 10 mg tablets |
Torasemide |
10 mg |
tablet |
Oral use |
Cyprus |
Accord Healthcare S.L.U |
|
Amlodipin Accord tablet 5mg |
Amlodipine |
5 mg |
Tablet |
Oral use |
Cyprus |
Accord Healthcare S.L.U |
|
Amlodipin Accord tablet 10mg |
Amlodipine |
10 mg |
Tablet |
Oral use |
Cyprus |
Delorbis Pharmaceutica LS LTD |
|
Zormid Eye Drops, Solution 20Mg/Ml |
Dorzolamide |
20 mg/ml |
Eye drops, solution |
Ocular use |
Czech Republic |
Accord Healthcare Polska Sp. z o.o. |
|
Amlodipin Accord |
Amlodipine |
5 mg |
Tablet |
Oral use |
Czech Republic |
Accord Healthcare Polska Sp. z o.o. |
|
Amlodipin Accord |
Amlodipine |
10 mg |
Tablet |
Oral use |
Czech Republic |
Mylan Ireland Limited |
|
TRAMYLPA |
Tramadol/paracetamol |
37,5 mg/325 mg |
Film-coated tablet |
Oral use |
Denmark |
Accord Healthcare B.V. |
|
Amlodipin Accord |
Amlodipine |
5 mg |
Tablet |
Oral use |
Denmark |
Accord Healthcare B.V. |
|
Amlodipin Accord |
Amlodipine |
5 mg |
Tablet |
Oral use |
Denmark |
Accord Healthcare B.V. |
|
Amlodipin Accord |
Amlodipine |
10 mg |
Tablet |
Oral use |
Denmark |
Accord Healthcare B.V. |
|
Amlodipin Accord |
Amlodipine |
10 mg |
Tablet |
Oral use |
Estonia |
Teva Pharma B.V. |
|
Torasemide Teva |
Torasemide |
5 mg |
Tablet |
Oral use |
Estonia |
Teva Pharma B.V. |
|
Torasemide Teva |
Torasemide |
10 mg |
Tablet |
Oral use |
Finland |
Accord Healthcare B.V. |
|
Amlodipin Accord |
Amlodipine |
5 mg |
Tablet |
Oral use |
Finland |
Accord Healthcare B.V. |
|
Amlodipin Accord |
Amlodipine |
10 mg |
Tablet |
Oral use |
France |
Mylan SAS |
|
TIANEPTINE MYLAN PHARMA 12,5 mg, comprimé enrobé |
Tianeptine |
12,5 mg |
Coated tablet |
Oral use |
Germany |
Heumann Pharma GmbH & Co. Generica KG |
|
Azithromycin Heumann |
Azithromycin |
250 mg |
Film-coated tablet |
Oral use |
Germany |
Heumann Pharma GmbH & Co. Generica KG |
|
Azithromycin Heumann |
Azithromycin |
500 mg |
Film-coated tablet |
Oral use |
Germany |
Heumann Pharma GmbH & Co. Generica KG |
|
Dorzolamid Heumann 20 mg/ml Augentropfen |
Dorzolamide |
20 mg/ml |
Eye drops, solution |
Ocular use |
Germany |
|
Hormosan Pharma |
Tianesan 12,5 mg Filmtabletten |
Tianeptine |
12,5 mg |
film-coated tablet |
Oral use |
Germany |
Aliud Pharma GmbH |
|
Torasemid AL 5 mg Tabletten |
Torasemide |
5 mg |
Tablet |
Oral use |
Germany |
Aliud Pharma GmbH |
|
Torasemid AL 10 mg Tabletten |
Torasemide |
10 mg |
Tablet |
Oral use |
Germany |
ratiopharm GmbH |
|
Torasemid-ratiopharm 5 mg Tabletten |
Torasemide |
5 mg |
Tablet |
Oral use |
Germany |
ratiopharm GmbH |
|
Torasemid-ratiopharm 10 mg Tabletten |
Torasemide |
10 mg |
Tablet |
Oral use |
Germany |
STADAPHARM GmbH |
|
Torasemid STADA 5 mg Tabletten |
Torasemide |
5 mg |
Tablet |
Oral use |
Germany |
STADAPHARM GmbH |
|
Torasemid STADA 10 mg Tabletten |
Torasemide |
10 mg |
Tablet |
Oral use |
Germany |
Abz-Pharma Gmbh |
|
Torasemid AbZ 5 mg Tabletten |
Torasemide |
5 mg |
Tablet |
Oral use |
Germany |
Abz-Pharma Gmbh |
|
Torasemid AbZ 10 mg Tabletten |
Torasemide |
10 mg |
Tablet |
Oral use |
Germany |
STADAPHARM |
|
Tramadolhydrochlorid/Paracetamol STADA 37,5 mg/325 mg Filmtabletten |
Tramadol/paracetamol |
37,5 mg/325 mg |
Film-coated tablet |
Oral use |
Greece |
Rafarm A.E.B.E |
|
Rexazon |
Dexamethasone |
2 mg |
Soluble tablet |
Oral use |
Greece |
Rafarm A.E.B.E |
|
Rexazon |
Dexamethasone |
4 mg |
Soluble tablet |
Oral use |
Greece |
Rafarm A.E.B.E |
|
Rexazon |
Dexamethasone |
8 mg |
Soluble tablet |
Oral use |
Ireland |
Accord Healthcare Ireland Ltd |
|
Amlodipine 5mg tablets |
Amlodipine |
5 mg |
Tablet |
Oral use |
Ireland |
Accord Healthcare Ireland Ltd |
|
Amlodipine 10mg tablets |
Amlodipine |
10 mg |
Tablet |
Oral use |
Ireland |
Clonmel Healthcare Ltd, |
|
Xymel Comp 37.5mg/325mg Film-Coated Tablets |
Tramadol/paracetamol |
37,5 mg/325 mg |
Film-coated tablet |
Oral use |
Italy |
Accord Healthcare S.L.U |
|
Amlodipina Accord |
Amlodipine |
5 mg |
Tablet |
Oral use |
Italy |
Accord Healthcare S.L.U |
|
Amlodipina Accord |
Amlodipine |
10 mg |
Tablet |
Oral use |
Italy |
Epionpharma S.r.l. |
|
Varcodes |
Dexamethasone |
2 mg |
Effervescent tablet |
Oral use |
Italy |
Epionpharma S.r.l. |
|
Varcodes |
Dexamethasone |
4 mg |
Effervescent tablet |
Oral use |
Italy |
Epionpharma S.r.l. |
|
Varcodes |
Dexamethasone |
8 mg |
Effervescent tablet |
Oral use |
Italy |
Aurora Biofarma Srl. |
|
AUROZEB |
Rosuvastatin/ezetimibe |
5 mg/10 mg |
Film-coated tablet |
Oral use |
Italy |
Aurora Biofarma Srl. |
|
AUROZEB |
Rosuvastatin/ezetimibe |
10 mg/10 mg |
Film-coated tablet |
Oral use |
Italy |
Aurora Biofarma Srl. |
|
AUROZEB |
Rosuvastatin/ezetimibe |
20 mg/10 mg |
Film-coated tablet |
Oral use |
Italy |
Aurora Biofarma Srl. |
|
AUROZEB |
Rosuvastatin/ezetimibe |
40 mg/10 mg |
Film-coated tablet |
Oral use |
Italy |
Teva Italia S.r.l. |
|
Torasemide Teva Italia 10 mg compresse |
Torasemide |
10 mg |
Tablet |
Oral use |
Latvia |
Teva Pharma B.V. |
|
Torasemide Teva 5 mg tabletes |
Torasemide |
5 mg |
Tablet |
Oral use |
Latvia |
Teva Pharma B.V. |
|
Torasemide Teva 10 mg tabletes |
Torasemide |
10 mg |
Tablet |
Oral use |
Lithuania |
Teva Pharma B.V. |
|
Torasemide Teva 5 mg tabletės |
Torasemide |
5 mg |
Tablet |
Oral use |
Lithuania |
Teva Pharma B.V. |
|
Torasemide Teva 10 mg tabletės |
Torasemide |
10 mg |
Tablet |
Oral use |
Luxembourg |
Eurogenerics N.V./S.A. |
|
Tramadol/Paracetamol EG 37,5 / 325mg comprimés pelliculés |
Tramadol/paracetamol |
37,5 mg/325 mg |
Film-coated tablet |
Oral use |
Norway |
Accord Healthcare B.V. |
|
Amlodipin Accord |
Amlodipine |
5 mg |
Tablet |
Oral use |
Norway |
Accord Healthcare B.V. |
|
Amlodipin Accord |
Amlodipine |
10 mg |
Tablet |
Oral use |
Poland |
Accord Healthcare Polska Sp. z o.o. |
|
Almiden |
Amlodipine |
5 mg |
Tablet |
Oral use |
Poland |
Accord Healthcare Polska Sp. z o.o. |
|
Almiden |
Amlodipine |
10 mg |
Tablet |
Oral use |
Poland |
Teva Pharmaceuticals Polska Sp. z o.o. |
|
Diuver |
Torasemide |
5 mg |
Tablet |
Oral use |
Poland |
Teva Pharmaceuticals Polska Sp. z o.o. |
|
Diuver |
Torasemide |
10 mg |
Tablet |
Oral use |
Portugal |
Accord Healthcare B.V. |
|
Amlodipin Accord |
Amlodipine |
5 mg |
Tablet |
Oral use |
Portugal |
Accord Healthcare B.V. |
|
Amlodipin Accord |
Amlodipine |
10 mg |
Tablet |
Oral use |
Portugal |
Mylan, Lda. |
|
Tianeptina Mylan |
Tianeptine |
12,5 mg |
Film-coated tablet |
Oral use |
Portugal |
Lupin Europe GmbH |
|
Neluptin |
Tianeptine |
12,5 mg |
Film-coated tablet |
Oral use |
Portugal |
Mylan, Lda. |
|
Tramadol + Paracetamol Mylan |
Tramadol/paracetamol |
37,5 mg/325 mg |
Film-coated tablet |
Oral use |
Romania |
Antibiotice S.A |
|
NOBIXAL 12,5 mg |
Tianeptine |
12,5 mg |
Film-coated tablet |
Oral use |
Slovakia |
Mylan Ireland Limited |
|
Tianeptin Mylan 12,5 mg |
Tianeptine |
12,5 mg |
Film-coated tablet |
Oral use |
Slovakia |
Mylan Ireland Limited |
|
Tramylpa 37,5 mg/325 mg |
Tramadol/paracetamol |
37,5 mg/325 mg |
Film-coated tablet |
Oral use |
Slovenia |
Pliva Ljubljana d.o.o. |
|
Diuver |
Torasemide |
5 mg |
Tablet |
Oral use |
Slovenia |
Pliva Ljubljana d.o.o. |
|
Diuver |
Torasemide |
10 mg |
Tablet |
Oral use |
Spain |
Accord Healthcare S.L.U |
|
AMLODIPINO ACCORD 5 mg comprimidos EFG |
Amlodipine |
5 mg |
Tablet |
Oral use |
Spain |
Accord Healthcare S.L.U |
|
AMLODIPINO ACCORD 10 mg comprimidos EFG |
Amlodipine |
10 mg |
Tablet |
Oral use |
Spain |
|
Laboratorios Alter, S.A. |
ARROX PLUS 10 mg/10 mg comprimidos recubiertos con película |
Rosuvastatin/ezetimibe |
10 mg/10 mg |
Film-coated tablet |
Oral use |
Spain |
|
Laboratorios Alter, S.A. |
ARROX PLUS 20 mg/10 mg comprimidos recubiertos con película |
Rosuvastatin/ezetimibe |
20 mg/10 mg |
Film-coated tablet |
Oral use |
Spain |
|
Laboratorios Alter, S.A. |
ARROX PLUS 40 mg/10 mg comprimidos recubiertos con película |
Rosuvastatin/ezetimibe |
40 mg/10 mg |
Film-coated tablet |
Oral use |
Spain |
|
Laboratorios Alter, S.A. |
ROSUVASTATINA/EZETIMIBA ALTER 10 mg/10mg comprimidos recubiertos con película |
Rosuvastatin/ezetimibe |
10 mg/10 mg |
Film-coated tablet |
Oral use |
Spain |
|
Laboratorios Alter, S.A. |
ROSUVASTATINA/EZETIMIBA ALTER 20 mg/10mg comprimidos recubiertos con película |
Rosuvastatin/ezetimibe |
20 mg/10 mg |
Film-coated tablet |
Oral use |
Spain |
Laboratorio STADA, S.L. |
|
Torasemida STADA 5 mg |
Torasemide |
5 mg |
Tablet |
Oral use |
Spain |
Laboratorio STADA, S.L. |
|
Torasemida STADA 10 mg |
Torasemide |
10 mg |
Tablet |
Oral use |
Spain |
Laboratorio Stada, S.L. |
|
TRAMADOL/PARACETAMOL STADA 37,5 mg/325 mg comprimidos recubiertos con película EFG |
Tramadol/paracetamol |
37,5 mg/325 mg |
Film-coated tablet |
Oral use |
Spain |
Mylan Pharmaceuticals, S.L. |
|
TRAMADOL/PARACETAMOL MYLAN PHARMACEUTICALS 37,5 mg/325 mg comprimidos recubiertos con película EFG |
Tramadol/paracetamol |
37,5 mg/325 mg |
Film-coated tablet |
Oral use |
Spain |
Laboratorios Alter, S.A. |
|
TRAMADOL/PARACETAMOL ALTER 37,5 mg/325 mg comprimidos recubiertos con película EFG |
Tramadol/paracetamol |
37,5 mg/325 mg |
Film-coated tablet |
Oral use |
Sweden |
Jubilant Pharmaceuticals N.V. |
|
Amlodipin Jubilant |
Amlodipine |
5 mg |
Tablet |
Oral use |
Sweden |
Jubilant Pharmaceuticals N.V. |
|
Amlodipin Jubilant |
Amlodipine |
10 mg |
Tablet |
Oral use |
Sweden |
Accord Healthcare B.V. |
|
Amlodipin Accord |
Amlodipine |
5 mg |
Tablet |
Oral use |
Sweden |
Accord Healthcare B.V. |
|
Amlodipin Accord |
Amlodipine |
10 mg |
Tablet |
Oral use |
Sweden |
Orifarm Generics A/S |
|
Hydrokortison Orifarm |
Hydrocortisone |
10 mg |
Tablet |
Oral use |
Sweden |
Orifarm Generics A/S |
|
Hydrokortison Orifarm |
Hydrocortisone |
20 mg |
Tablet |
Oral use |
The Netherlands |
Jubilant Pharmaceuticals N.V. |
|
Amlodipine (als besilaat) Jubilant 5 mg, tabletten |
Amlodipine |
5 mg |
Tablet |
Oral use |
The Netherlands |
Jubilant Pharmaceuticals N.V. |
|
Amlodipine (als besilaat) Jubilant 10 mg, tabletten |
Amlodipine |
10 mg |
Tablet |
Oral use |
The Netherlands |
Accord Healthcare B.V. |
|
Amlodipine (als besilaat) Accord 5 mg, tabletten |
Amlodipine |
5 mg |
Tablet |
Oral use |
The Netherlands |
Accord Healthcare B.V. |
|
Amlodipine (als besilaat) Accord 10 mg, tabletten |
Amlodipine |
10 mg |
Tablet |
Oral use |
The Netherlands |
Aurora Biofarma Srl. |
|
Rozemib 5 mg/10 mg, filmomhulde tabletten |
Rosuvastatin/ezetimibe |
5 mg/10 mg |
Film-coated tablet |
Oral use |
The Netherlands |
Aurora Biofarma Srl. |
|
Rozemib 10 mg/10 mg, filmomhulde tabletten |
Rosuvastatin/ezetimibe |
10 mg/10 mg |
Film-coated tablet |
Oral use |
The Netherlands |
Aurora Biofarma Srl. |
|
Rozemib 20 mg/10 mg, filmomhulde tabletten |
Rosuvastatin/ezetimibe |
20 mg/10 mg |
Film-coated tablet |
Oral use |
The Netherlands |
Aurora Biofarma Srl. |
|
Rozemib 40 mg/10 mg, filmomhulde tabletten |
Rosuvastatin/ezetimibe |
40 mg/10 mg |
Film-coated tablet |
Oral use |
United Kingdom (Northern Ireland) |
Accord Healthcare Limited |
|
Amlodipine 5 mg Tablets |
Amlodipine |
5 mg |
Tablet |
Oral use |
United Kingdom (Northern Ireland) |
Accord Healthcare Limited |
|
Amlodipine 10 mg Tablets |
Amlodipine |
10 mg |
Tablet |
Oral use |
United Kingdom (Northern Ireland) |
Teva UK Limited |
|
Torasemide 5 mg Tablets |
Torasemide |
5 mg |
Tablet |
Oral use |
United Kingdom (Northern Ireland) |
Teva UK Limited |
|
Torasemide 10 mg Tablets |
Torasemide |
10 mg |
Tablet |
Oral use |
Annex IB. Medicinal products for which the marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation
Member State EU/EEA |
Marketing Authorisation Holder |
Applicant |
Invented name |
INN |
Strength |
Pharmaceutical form |
Route of administration |
Austria |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides 200 mg Filmtabletten |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Austria |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides 400 mg |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Austria |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides 600 mg |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Austria |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides 800 mg |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
Austria |
|
Fair-med Healthcare GmbH |
Ibuprofen FMH 200 mg Filmtabletten |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Austria |
|
Fair-med Healthcare GmbH |
Ibuprofen FMH 400 mg Filmtabletten |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Austria |
|
Fair-med Healthcare GmbH |
Ibuprofen FMH 600 mg Filmtabletten |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Austria |
|
Fair-med Healthcare GmbH |
Ibuprofen FMH 800 mg Filmtabletten |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
Austria |
Aziende Chimiche Riunite Angelini Francesco S.p.A |
|
BoxaGrippal 200 mg/30 mg Weichkapseln |
Ibuprofen/pseudoephedrine |
200 mg/30 mg |
Capsule, soft |
Oral use |
Belgium |
Mylan S.P.R.L.-B.V.B.A. |
|
Atorvastatine Mylan 10 mg filmomhulde tabletten |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Belgium |
Mylan S.P.R.L.-B.V.B.A. |
|
Atorvastatine Mylan 20 mg filmomhulde tabletten |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Belgium |
Mylan S.P.R.L.-B.V.B.A. |
|
Atorvastatine Mylan 40 mg filmomhulde tabletten |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Belgium |
Mylan S.P.R.L.-B.V.B.A. |
|
Atorvastatine Mylan 80 mg filmomhulde tabletten |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Belgium |
Mylan S.P.R.L.-B.V.B.A. |
|
AtorvastaMylan 10 mg filmomhulde tabletten |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Belgium |
Mylan S.P.R.L.-B.V.B.A. |
|
AtorvastaMylan 20 mg filmomhulde tabletten |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Belgium |
Mylan S.P.R.L.-B.V.B.A. |
|
AtorvastaMylan 40 mg filmomhulde tabletten |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Belgium |
Mylan S.P.R.L.-B.V.B.A. |
|
AtorvastaMylan 80 mg filmomhulde tabletten |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Belgium |
Mylan S.P.R.L.-B.V.B.A. |
|
Mylanatorvastigen 10 mg [Film-coated tablet] |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Belgium |
Mylan S.P.R.L.-B.V.B.A. |
|
Mylanatorvastigen 20 mg [Film-coated tablet] |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Belgium |
Mylan S.P.R.L.-B.V.B.A. |
|
Mylanatorvastigen 40 mg [Film-coated tablet] |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Belgium |
Mylan S.P.R.L.-B.V.B.A. |
|
Mylanatorvastigen 80 mg [Film-coated tablet] |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Belgium |
JOHNSON & JOHNSON CONSUMER N.V./S.A. |
|
Bronchosedal Dextromethorphan Unidose 15 mg oral solution in sachet |
Dextromethorphan |
15 mg/5 ml |
Oral solution in sachet |
Oral use |
Belgium |
Mylan bvba/sprl |
|
Efavirenz Mylan |
Efavirenz |
600 mg |
Film-coated tablet |
Oral use |
Belgium |
|
Tillomed Pharma GmbH |
Paliperidon Tillomed 3 mg, tabletten met verlengde afgifte |
Paliperidone |
3 mg |
Prolonged-release tablet |
Oral use |
Belgium |
|
Tillomed Pharma GmbH |
Paliperidon Tillomed 6 mg, tabletten met verlengde afgifte |
Paliperidone |
6 mg |
Prolonged-release tablet |
Oral use |
Belgium |
|
Tillomed Pharma GmbH |
Paliperidon Tillomed 9 mg, tabletten met verlengde afgifte |
Paliperidone |
9 mg |
Prolonged-release tablet |
Oral use |
Belgium |
|
Theramex Ireland Limited |
Ovalute 100 mg, zachte capsule |
Progesterone |
100 mg |
Capsule, soft |
Oral use |
Belgium |
|
Theramex Ireland Limited |
Ovalute 200 mg, zachte capsule |
Progesterone |
200 mg |
Capsule, soft |
Oral use |
Belgium |
Mylan bvba/sprl |
|
Zolmitriptan ODIS Mylan |
Zolmitriptan |
2,5 mg |
Orodispersible tablet |
Oral use |
Belgium |
Mylan bvba/sprl |
|
Zolmitriptan ODIS Mylan |
Zolmitriptan |
5 mg |
Orodispersible tablet |
Oral use |
Bulgaria |
Mylan Ireland Limited |
|
Atorgen 10 mg film — coated tablets |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Bulgaria |
Mylan Ireland Limited |
|
Atorgen 20 mg film — coated tablets |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Bulgaria |
|
STADA Arzneimittel AG |
Parabol |
Ibuprofen/paracetamol |
200 mg/500 mg |
Capsule, soft |
Oral use |
Bulgaria |
STADA Arzneimittel AG |
|
Grippostad StopCold |
Ibuprofen/pseudoephedrine |
200 mg/30 mg |
Capsule, soft |
Oral use |
Croatia |
|
STADA Arzneimittel AG |
Combodolor 200 mg/500 mg meke kapsule |
Ibuprofen/paracetamol |
200 mg/500 mg |
Capsule, soft |
Oral use |
Cyprus |
Generics Pharma Hellas Ltd |
|
Atorvastatin Generics 10 mg film-coated tablets |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Cyprus |
Generics Pharma Hellas Ltd |
|
Atorvastatin Generics 20 mg film-coated tablets |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Cyprus |
Generics Pharma Hellas Ltd |
|
Atorvastatin Generics 40 mg film-coated tablets |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Cyprus |
Hellas Ltd |
|
Cencipral Tablet, Film Coated 30Mg |
Cinacalcet |
30 mg |
Film-coated tablet |
Oral use |
Cyprus |
Remedica LTD |
|
Cencipral Tablet, Film Coated 60Mg |
Cinacalcet |
60 mg |
Film-coated tablet |
Oral use |
Cyprus |
Remedica LTD |
|
Cencipral Tablet, Film Coated 90Mg |
Cinacalcet |
90 mg |
Film-coated tablet |
Oral use |
Cyprus |
Nassington LTD |
|
Zircos Tablet, Film Coated 5Mg |
Rosuvastatin |
5 mg |
Film-coated tablet |
Oral use |
Cyprus |
Nassington LTD |
|
Zircos Tablet, Film Coated 10Mg |
Rosuvastatin |
10 mg |
Film-coated tablet |
Oral use |
Cyprus |
Nassington LTD |
|
Zircos Tablet, Film Coated 20Mg |
Rosuvastatin |
20 mg |
Film-coated tablet |
Oral use |
Czech Republic |
Mylan Ireland Limited |
|
Atorvastatin Mylan 10 mg potahované tablety |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Czech Republic |
Mylan Ireland Limited |
|
Atorvastatin Mylan 20 mg potahované tablety |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Czech Republic |
Mylan Ireland Limited |
|
Atorvastatin Mylan 40 mg potahované tablety |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Czech Republic |
|
Strides Pharma (Cyprus) Limited |
IBUPROFEN STRIDES |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Czech Republic |
|
Strides Pharma (Cyprus) Limited |
IBUPROFEN STRIDES |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Czech Republic |
|
Strides Pharma (Cyprus) Limited |
IBUPROFEN STRIDES |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Czech Republic |
|
Strides Pharma (Cyprus) Limited |
IBUPROFEN STRIDES |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
Czech Republic |
|
PharmConsul s.r.o. |
Brumet (previously Ibuber) |
Ibuprofen |
400 mg |
Capsule, soft |
Oral use |
Czech Republic |
|
PharmConsul s.r.o. |
Ibamed (previously Ibuprofen Pharmconsul) |
Ibuprofen |
400 mg |
Capsule, soft |
Oral use |
Czech Republic |
|
PharmConsul s.r.o. |
Ibivil (previously Ibunex) |
Ibuprofen |
400 mg |
Capsule, soft |
Oral use |
Czech Republic |
|
STADA Arzneimittel AG |
STADALGEN |
Paracetamol/ibuprofen |
200 mg/500 mg |
Capsule, soft |
Oral use |
Czech Republic |
Actavis Group PTC ehf. |
|
FOXIS |
Tramadol/paracetamol |
37,5 mg/325 mg |
film-coated tablet |
oral use |
Czech republic |
Mylan Ireland Limited |
|
PIOGLITAZON MYLAN |
Pioglitazone |
15 mg |
Tablet |
Oral use |
Czech republic |
Mylan Ireland Limited |
|
PIOGLITAZON MYLAN |
Pioglitazone |
30 mg |
Tablet |
Oral use |
Denmark |
Orifarm Generics A/S |
|
Alfacalcidol ‘Orifarm’ |
Alfacalcidol |
0,25 mcg |
Capsule, soft |
Oral use |
Denmark |
Orifarm Generics A/S |
|
Alfacalcidol ‘Orifarm’ |
Alfacalcidol |
0,5 mcg |
Capsule, soft |
Oral use |
Denmark |
Orifarm Generics A/S |
|
Alfacalcidol ‘Orifarm’ |
Alfacalcidol |
1 mcg |
Capsule, soft |
Oral use |
Denmark |
Mylan AB |
|
Atorvastatin ‘Mylan’ |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Denmark |
Mylan AB |
|
Atorvastatin ‘Mylan’ |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Denmark |
Mylan AB |
|
Atorvastatin ‘Mylan’ |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Denmark |
Mylan AB |
|
Atorvastatin ‘Mylan’ |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Denmark |
|
Amarox Pharma B.V. |
Atorvastatin ‘Amarox’ |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Denmark |
|
Amarox Pharma B.V. |
Atorvastatin ‘Amarox’ |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Denmark |
|
Amarox Pharma B.V. |
Atorvastatin ‘Amarox’ |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Denmark |
|
Amarox Pharma B.V. |
Atorvastatin ‘Amarox’ |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Denmark |
2care4 Generics Aps |
|
Carexarit |
Clonidine |
25 mcg |
Coated tablet |
Oral use |
Denmark |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen ‘Strides’ |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Denmark |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen ‘Strides’ |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Denmark |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen ‘Strides’ |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Denmark |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen ‘Strides’ |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
Denmark |
Bristol Laboratories Ltd. |
|
Ibuprofen ‘Bril’ |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Denmark |
Bristol Laboratories Ltd. |
|
Ibuprofen ‘Bril’ |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Denmark |
Bristol Laboratories Ltd. |
|
Ibuprofen ‘Bril’ |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Denmark |
Orifarm Generics A/S |
|
Farmidur |
Isosorbide mononitrate |
30 mg |
Prolonged-release tablet |
Oral use |
Denmark |
Aristo Pharma GmbH |
|
Kagitz |
Quetiapine |
50 mg |
Prolonged-release tablet |
Oral use |
Denmark |
Aristo Pharma GmbH |
|
Kagitz |
Quetiapine |
300 mg |
Prolonged-release tablet |
Oral use |
Denmark |
Aristo Pharma GmbH |
|
Kagitz |
Quetiapine |
400 mg |
Prolonged-release tablet |
Oral use |
Finland |
Orifarm Generics A/S |
|
Alfacalcidol Orifarm |
Alfacalcidol |
0,25 mcg |
Capsule, soft |
Oral use |
Finland |
Orifarm Generics A/S |
|
Alfacalcidol Orifarm |
Alfacalcidol |
0,5 mcg |
Capsule, soft |
Oral use |
Finland |
Orifarm Generics A/S |
|
Alfacalcidol Orifarm |
Alfacalcidol |
1 mcg |
Capsule, soft |
Oral use |
Finland |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Finland |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Finland |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Finland |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
Finland |
|
Fair-med Healthcare GmbH |
Ibuprofen Fmh |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Finland |
|
Fair-med Healthcare GmbH |
Ibuprofen Fmh |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Finland |
|
Fair-med Healthcare GmbH |
Ibuprofen Fmh |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Finland |
|
Fair-med Healthcare GmbH |
Ibuprofen Fmh |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
France |
Viatris Santé |
|
Atorvastatine Viatris 10mg, comprimé pelliculé |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
France |
Viatris Santé |
|
Atorvastatine Viatris 20mg, comprimé pelliculé |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
France |
Viatris Santé |
|
Atorvastatine Viatris 40mg, comprimé pelliculé |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
France |
Viatris Santé |
|
Atorvastatine Viatris 80mg, comprimé pelliculé |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
France |
Mylan SAS |
|
EFAVIRENZ MYLAN 600 mg, comprimé pelliculé |
Efavirenz |
600 mg |
Film-coated tablet |
Oral use |
France |
|
Fair-Med Healthcare GmbH |
IBUPROFÈNE FMH 200 mg, comprimé pelliculé |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
France |
|
Fair-Med Healthcare GmbH |
IBUPROFÈNE FMH 400 mg, comprimé pelliculé |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
France |
|
Fair-Med Healthcare GmbH |
IBUPROFÈNE FMH 600 mg, comprimé pelliculé |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
France |
|
Fair-Med Healthcare GmbH |
IBUPROFÈNE FMH 800 mg, comprimé pelliculé |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
France |
|
Theramex Ireland Limited |
OVALUTE 100 mg, capsule molle |
Progesterone |
100 mg |
Capsule, soft |
Oral use |
France |
|
Theramex Ireland Limited |
OVALUTE 200 mg, capsule molle |
Progesterone |
200 mg |
Capsule, soft |
Oral use |
France |
Mylan SAS |
|
ZOLMITRIPTAN MYLAN 2,5 mg, comprimé pelliculé |
Zolmitriptan |
2,5 mg |
Film-coated tablet |
Oral use |
France |
Mylan SAS |
|
ZOLMITRIPTAN MYLAN 2,5 mg, comprimé orodispersible |
Zolmitriptan |
2,5 mg |
Orodispersible tablet |
Oral use |
Germany |
1 A Pharma GmbH |
|
Alfacalcidol — 1 A Pharma 0,25 mcg Weichkapseln |
Alfacalcidol |
0,25 mcg |
Capsule, soft |
Oral use |
Germany |
1 A Pharma GmbH |
|
Alfacalcidol — 1 A Pharma 0,5 mcg Weichkapseln |
Alfacalcidol |
0,5 mcg |
Capsule, soft |
Oral use |
Germany |
1 A Pharma GmbH |
|
Alfacalcidol — 1 A Pharma 1 mcg Weichkapseln |
Alfacalcidol |
1 mcg |
Capsule, soft |
Oral use |
Germany |
Hexal AG |
|
Alfacalcidol HEXAL 0.25 mcg Weichkapseln |
Alfacalcidol |
0,25 mcg |
Capsule, soft |
Oral use |
Germany |
Hexal AG |
|
Alfacalcidol HEXAL 0.5 mcg Weichkapseln |
Alfacalcidol |
0,5 mcg |
Capsule, soft |
Oral use |
Germany |
Hexal AG |
|
Alfacalcidol HEXAL 1 mcg Weichkapseln |
Alfacalcidol |
1 mcg |
Capsule, soft |
Oral use |
Germany |
|
Amarox Pharma B.V. |
Atorvastatin Amarox 10 mg Filmtabletten |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Germany |
|
Amarox Pharma B.V. |
Atorvastatin Amarox 20 mg Filmtabletten |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Germany |
|
Amarox Pharma B.V. |
Atorvastatin Amarox 40 mg Filmtabletten |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Germany |
|
Amarox Pharma B.V. |
Atorvastatin Amarox 80 mg Filmtabletten |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Germany |
Tillomed Pharma GmbH |
|
Ezetimib/Simvastatin Tillomed 10 mg/ 10 mg Tabletten |
Ezetimibe/simvastatin |
10 mg/10 mg |
Tablet |
Oral use |
Germany |
Tillomed Pharma GmbH |
|
Ezetimib/Simvastatin Tillomed 10 mg/ 20 mg Tabletten |
Ezetimibe/simvastatin |
10 mg/20 mg |
Tablet |
Oral use |
Germany |
Tillomed Pharma GmbH |
|
Ezetimib/Simvastatin Tillomed 10 mg/ 40 mg Tabletten |
Ezetimibe/simvastatin |
10 mg/40 mg |
Tablet |
Oral use |
Germany |
Tillomed Pharma GmbH |
|
Ezetimib/Simvastatin Tillomed 10 mg/ 80 mg Tabletten |
Ezetimibe/simvastatin |
10 mg/80 mg |
Tablet |
Oral use |
Germany |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides 200 mg Filmtabletten |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Germany |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides 400 mg Filmtabletten |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Germany |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides 600 mg Filmtabletten |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Germany |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides 800 mg Filmtabletten |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
Germany |
|
Fair-Med Healthcare GmbH |
Ibuprofen FMH 200 mg Filmtabletten |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Germany |
|
Fair-Med Healthcare GmbH |
Ibuprofen FMH 400 mg Filmtabletten |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Germany |
|
Fair-Med Healthcare GmbH |
Ibuprofen FMH 600 mg Filmtabletten |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Germany |
|
Fair-Med Healthcare GmbH |
Ibuprofen FMH 800 mg Filmtabletten |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
Germany |
Brillpharma (Ireland) Limited |
|
Ibuprofen Bril |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Germany |
Brillpharma (Ireland) Limited |
|
Ibuprofen Bril |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Germany |
Brillpharma (Ireland) Limited |
|
Ibuprofen Bril |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Germany |
Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco — A.C.R.A.F. S.P.A. |
|
BoxaGrippal 200 mg/30 mg Weichkapseln |
Ibuprofen/pseudoephedrine |
200 mg/30 mg |
Capsule, soft |
Oral use |
Germany |
|
PharmaMatch B.V. |
Ibuprofen 200 mg/ Pseudoephedrine 30 mg Kapsel |
Ibuprofen/pseudoephedrine |
200 mg/30 mg |
Capsule, soft |
Oral use |
Germany |
Infectopharm Arzneimittel und Consilium GmbH |
|
MetfoLiquid Geriasan 1 000 mg/5 ml, Lösung zum Einnehmen |
Metformin |
1 000 mg/5 ml |
Oral solution |
Oral use |
Germany |
Tillomed Pharma GmbH |
|
Oxybutyninhydrochlorid Creative 2,5 mg Tabletten |
Oxybutynin |
2,5 mg |
Tablet |
Oral use |
Germany |
Tillomed Pharma GmbH |
|
Oxybutyninhydrochlorid Creative 5 mg Tabletten |
Oxybutynin |
5 mg |
Tablet |
Oral use |
Germany |
|
PharmaMatch B.V. |
Progesteron PharmaMatch 100 mg Weichkapseln |
Progesterone |
100 mg |
Capsule, soft |
Oral use |
Germany |
|
PharmaMatch B.V. |
Progesteron PharmaMatch 200 mg Weichkapseln |
Progesterone |
200 mg |
Capsule, soft |
Oral use |
Germany |
|
Theramex Ireland Limited |
Ovalute 100 mg Weichkapseln |
Progesterone |
100 mg |
Capsule, soft |
Oral use |
Germany |
|
Theramex Ireland Limited |
Ovalute 200 mg Weichkapseln |
Progesterone |
200 mg |
Capsule, soft |
Oral use |
Germany |
|
Micro Labs GmbH |
Rosuvastatin Micro Labs 10 mg Filmtabletten |
Rosuvastatin |
10 mg |
Film-coated tablet |
Oral use |
Germany |
|
Micro Labs GmbH |
Rosuvastatin Micro Labs 20 mg Filmtabletten |
Rosuvastatin |
20 mg |
Film-coated tablet |
Oral use |
Germany |
|
Micro Labs GmbH |
Rosuvastatin Micro Labs 40 mg Filmtabletten |
Rosuvastatin |
40 mg |
Film-coated tablet |
Oral use |
Germany |
Mylan Germany GmbH |
|
Zolmitriptan dura Filmtabletten |
Zolmitriptan |
2,5 mg |
Film-coated tablet |
Oral use |
Germany |
Mylan Germany GmbH |
|
Zolmitriptan dura Filmtabletten |
Zolmitriptan |
5 mg |
Film-coated tablet |
Oral use |
Germany |
Mylan Germany GmbH |
|
Zolmitriptan dura Schmelztabletten |
Zolmitriptan |
2,5 mg |
Orodispersible tablet |
Oral use |
Germany |
Mylan Germany GmbH |
|
Zolmitriptan dura Schmelztabletten |
Zolmitriptan |
5 mg |
Orodispersible tablet |
Oral use |
Greece |
Mylan Ireland Limited |
|
Atorvastatin/Mylan Film-coated Tablets |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Greece |
Mylan Ireland Limited |
|
Atorvastatin/Mylan Film-coated Tablets |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Greece |
Mylan Ireland Limited |
|
Atorvastatin/Mylan Film-coated Tablets |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Greece |
Bennet Pharmaceutica L A.E. |
|
Memaben |
Memantine |
5 mg + 10 mg + 15 mg + 20 mg |
Soluble tablet |
Oral use |
Greece |
Bennet Pharmaceutica L A.E. |
|
Memaben |
Memantine |
10 mg |
Soluble tablet |
Oral use |
Greece |
Bennet Pharmaceutica L A.E. |
|
Memaben |
Memantine |
20 mg |
Soluble tablet |
Oral use |
Greece |
Vita Longa I.K.E. (Vita Longa P.C.) |
|
Lycis |
Metformin |
1 000 mg/5 ml |
Oral solution |
Oral use |
Greece |
|
Tillomed Pharma GmbH |
Paliperidone Tillomed |
Paliperidone |
3 mg |
Prolonged-release tablet |
Oral use |
Greece |
|
Tillomed Pharma GmbH |
Paliperidone Tillomed |
Paliperidone |
6 mg |
Prolonged-release tablet |
Oral use |
Greece |
|
Tillomed Pharma GmbH |
Paliperidone Tillomed |
Paliperidone |
9 mg |
Prolonged-release tablet |
Oral use |
Greece |
Nassington LTD |
|
Rosupose |
Rosuvastatin |
5 mg |
Film-coated tablet |
Oral use |
Greece |
Nassington LTD |
|
Rosupose |
Rosuvastatin |
10 mg |
Film-coated tablet |
Oral use |
Greece |
Nassington LTD |
|
Rosupose |
Rosuvastatin |
20 mg |
Film-coated tablet |
Oral use |
Greece |
Medicair Bioscience Laboratories CY LTD |
|
Rosuvanox |
Rosuvastatin |
5 mg |
Film-coated tablet |
Oral use |
Greece |
Medicair Bioscience Laboratories CY LTD |
|
Rosuvanox |
Rosuvastatin |
10 mg |
Film-coated tablet |
Oral use |
Greece |
Medicair Bioscience Laboratories CY LTD |
|
Rosuvanox |
Rosuvastatin |
20 mg |
Film-coated tablet |
Oral use |
Greece |
VELKA Hellas A.E.B.E. |
|
Rosuvastatin/Velka |
Rosuvastatin |
5 mg |
Film-coated tablet |
Oral use |
Greece |
VELKA Hellas A.E.B.E. |
|
Rosuvastatin/Velka |
Rosuvastatin |
10 mg |
Film-coated tablet |
Oral use |
Greece |
VELKA Hellas A.E.B.E. |
|
Rosuvastatin/Velka |
Rosuvastatin |
20 mg |
Film-coated tablet |
Oral use |
Greece |
Lavipharm AE |
|
Rovastine |
Rosuvastatin |
5 mg |
Film-coated tablet |
Oral use |
Greece |
Lavipharm AE |
|
Rovastine |
Rosuvastatin |
10 mg |
Film-coated tablet |
Oral use |
Greece |
Lavipharm AE |
|
Rovastine |
Rosuvastatin |
20 mg |
Film-coated tablet |
Oral use |
Greece |
Rafarm A.E.B.E |
|
Zircos |
Rosuvastatin |
5 mg |
Film-coated tablet |
Oral use |
Greece |
Rafarm A.E.B.E |
|
Zircos |
Rosuvastatin |
10 mg |
Film-coated tablet |
Oral use |
Greece |
Rafarm A.E.B.E |
|
Zircos |
Rosuvastatin |
20 mg |
Film-coated tablet |
Oral use |
Greece |
Nassington LTD |
|
Zolvara |
Rosuvastatin |
5 mg |
Film-coated tablet |
Oral use |
Greece |
Nassington LTD |
|
Zolvara |
Rosuvastatin |
10 mg |
Film-coated tablet |
Oral use |
Greece |
Nassington LTD |
|
Zolvara |
Rosuvastatin |
20 mg |
Film-coated tablet |
Oral use |
Greece |
|
Nassington LTD |
Mesi-2 |
Sitagliptin/metformin |
50 mg/850 mg |
Film-coated tablet |
Oral use |
Greece |
|
Nassington LTD |
Mesi-2 |
Sitagliptin/metformin |
50 mg/1 000 mg |
Film-coated tablet |
Oral use |
Greece |
|
Nassington LTD |
Metogline |
Vildagliptin/metformin |
50 mg/850 mg |
Film-coated tablet |
Oral use |
Greece |
|
Nassington LTD |
Metogline |
Vildagliptin/metformin |
50 mg/1 000 mg |
Film-coated tablet |
Oral use |
Greece |
|
Nassington LTD |
PERIVALE |
Sitagliptin/metformin |
50 mg/850 mg |
Film-coated tablet |
Oral use |
Greece |
|
Nassington LTD |
PERIVALE |
Sitagliptin/metformin |
50 mg/1 000 mg |
Film-coated tablet |
Oral use |
Greece |
|
Verisfield AE |
Toogluc |
Sitagliptin/metformin |
50 mg/850 mg |
Film-coated tablet |
Oral use |
Greece |
|
Verisfield AE |
Toogluc |
Sitagliptin/metformin |
50 mg/1 000 mg |
Film-coated tablet |
Oral use |
Hungary |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Hungary |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Hungary |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Hungary |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
Hungary |
|
STADA Arzneimittel AG |
Dolostad 200 mg/500 mg lágy kapszula |
Ibuprofen/paracetamol |
200 mg/500 mg |
Capsule, soft |
Oral use |
Hungary |
|
STADA Arzneimittel AG |
Dolostad 200 mg/500 mg lágy kapszula |
Ibuprofen/paracetamol |
200 mg/500 mg |
Capsule, soft |
Oral use |
Iceland |
Brillpharma (Ireland) Limited |
|
Ibuprofen Bril |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Iceland |
Brillpharma (Ireland) Limited |
|
Ibuprofen Bril |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Iceland |
Brillpharma (Ireland) Limited |
|
Ibuprofen Bril |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Ireland |
Bluefish Pharmaceuticals AB |
|
Co-amoxiclav Bluefish 500 mg/125 mg film- coated tablets |
Amoxicillin/ clavulanic acid |
500 mg/125 mg |
Film-coated tablet |
Oral use |
Ireland |
McDermott Laboratories Ltd |
|
Atorvastatin Mylan 10 mg film-coated tablets |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Ireland |
McDermott Laboratories Ltd |
|
Atorvastatin Mylan 20 mg film-coated tablets |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Ireland |
McDermott Laboratories Ltd |
|
Atorvastatin Mylan 40 mg film-coated tablets |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Ireland |
McDermott Laboratories Ltd |
|
Atorvastatin Mylan 80 mg film-coated tablets |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Ireland |
Pinewood Laboratories Limited |
|
Atorvastatin 10 mg Film-Coated Tablets |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Ireland |
Pinewood Laboratories Limited |
|
Atorvastatin 20 mg Film-Coated Tablets |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Ireland |
Pinewood Laboratories Limited |
|
Atorvastatin 40 mg Film-Coated Tablets |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Ireland |
Pinewood Laboratories Limited |
|
Atorvastatin 80 mg Film-Coated Tablets |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Ireland |
Brillpharma (Ireland) Limited |
|
Ibuprofen Bril |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Ireland |
Brillpharma (Ireland) Limited |
|
Ibuprofen Bril |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Ireland |
Brillpharma (Ireland) Limited |
|
Ibuprofen Bril |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Ireland |
|
Clonmel Healthcare Ltd |
Easofen Cold & Flu |
Ibuprofen/pseudoephedrine |
200 mg /20 mg |
Capsule, soft |
Oral use |
Ireland |
Clonmel Healthcare Ltd, |
|
Paralief 500 mg soft capsules |
Paracetamol |
500 mg |
Capsule, soft |
Oral use |
Ireland |
|
Theramex Ireland Limited |
Ovalute |
Progesterone |
100 mg |
Capsule, soft |
Oral use |
Ireland |
|
Theramex Ireland Limited |
Ovalute |
Progesterone |
200 mg |
Capsule, soft |
Oral use |
Italy |
Stewart Italia S.r.l. |
|
Stemox |
Amoxicillin/ clavulanic acid |
400 mg/5 ml + 57 mg/5 ml |
Powder for oral suspension |
Oral use |
Italy |
Mylan S.p.A. |
|
Atorvastatina Mylan Generics Italia |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Italy |
Mylan S.p.A. |
|
Atorvastatina Mylan Generics Italia |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Italy |
Mylan S.p.A. |
|
Atorvastatina Mylan Generics Italia |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Italy |
Mylan S.p.A. |
|
Atorvastatina Mylan Generics Italia |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Italy |
Mylan S.p.A. |
|
Efavirenz Mylan |
Efavirenz |
600 mg |
Film-coated tablet |
Oral use |
Italy |
|
Tillomed Pharma Gmbh |
Paliperidone Tillomed |
Paliperidone |
3 mg |
Prolonged-release tablet |
Oral use |
Italy |
|
Tillomed Pharma Gmbh |
Paliperidone Tillomed |
Paliperidone |
6 mg |
Prolonged-release tablet |
Oral use |
Italy |
|
Tillomed Pharma Gmbh |
Paliperidone Tillomed |
Paliperidone |
9 mg |
Prolonged-release tablet |
Oral use |
Italy |
Mylan S.p.A. |
|
Pioglitazone Mylan |
Pioglitazone |
15 mg |
Tablet |
Oral use |
Italy |
Mylan S.p.A. |
|
Pioglitazone Mylan |
Pioglitazone |
30 mg |
Tablet |
Oral use |
Italy |
Mylan S.p.A. |
|
Zolmitriptan Mylan Generics |
Zolmitriptan |
2,5 mg |
Film-coated tablet |
Oral use |
Italy |
Mylan S.p.A. |
|
Zolmitriptan Mylan Generics |
Zolmitriptan |
5 mg |
Film-coated tablet |
Oral use |
Luxembourg |
JOHNSON & JOHNSON CONSUMER N.V./S.A. |
|
Bronchosedal Dextromethorphan Unidose 15 mg oral solution en sachet |
Dextromethorphan |
15 mg/5 ml |
Oral solution in sachet |
Oral use |
Luxembourg |
|
PharmaMatch B.V. |
Progesteron PharmaMatch 100 mg Weichkapseln |
Progesterone |
100 mg |
Capsule, soft |
Oral use |
Luxembourg |
|
PharmaMatch B.V. |
Progesteron PharmaMatch 200 mg Weichkapseln |
Progesterone |
200 mg |
Capsule, soft |
Oral use |
Luxembourg |
Micro Labs GmbH |
|
Rosuvastatin Micro Labs 10 mg Filmtabletten |
Rosuvastatin |
10 mg |
Film-coated tablet |
Oral use |
Luxembourg |
Micro Labs GmbH |
|
Rosuvastatin Micro Labs 20 mg Filmtabletten |
Rosuvastatin |
20 mg |
Film-coated tablet |
Oral use |
Luxembourg |
Micro Labs GmbH |
|
Rosuvastatin Micro Labs 40 mg Filmtabletten |
Rosuvastatin |
40 mg |
Film-coated tablet |
Oral use |
Luxembourg |
Mylan bvba/sprl |
|
Zolmitriptan ODIS Mylan 2,5 mg comprimé orodispersible |
Zolmitriptan |
2,5 mg |
Orodispersible tablet |
Oral use |
Malta |
RIA Generics Ireland Limited |
|
Nefopam Hydrochloride 30 mg film-coated tablets |
Nefopam |
30 mg |
Film-coated tablet |
Oral use |
Norway |
Orifarm Generics A/S |
|
Alfacalcidol ‘Orifarm’ |
Alfacalcidol |
0,25 mcg |
Capsule, soft |
Oral use |
Norway |
Orifarm Generics A/S |
|
Alfacalcidol ‘Orifarm’ |
Alfacalcidol |
0,5 mcg |
Capsule, soft |
Oral use |
Norway |
Orifarm Generics A/S |
|
Alfacalcidol ‘Orifarm’ |
Alfacalcidol |
1 mcg |
Capsule, soft |
Oral use |
Norway |
Pensa Pharma AB |
|
Atorvastatin Pensa |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Norway |
Pensa Pharma AB |
|
Atorvastatin Pensa |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Norway |
Pensa Pharma AB |
|
Atorvastatin Pensa |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Norway |
Pensa Pharma AB |
|
Atorvastatin Pensa |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Norway |
2care4 Generics Aps |
|
Carexarit |
Clonidine |
25 mcg |
Coated tablet |
Oral use |
Norway |
Aristo Pharma GmbH |
|
Kagitz |
Quetiapine |
50 mg |
Prolonged-release tablet |
Oral use |
Norway |
Aristo Pharma GmbH |
|
Kagitz |
Quetiapine |
300 mg |
Prolonged-release tablet |
Oral use |
Norway |
Aristo Pharma GmbH |
|
Kagitz |
Quetiapine |
400 mg |
Prolonged-release tablet |
Oral use |
Poland |
Bluefish Pharmaceuticals AB |
|
Co-amoxiclav Bluefish 500 mg/125 mg film- coated tablets |
Amoxicillin/ clavulanic acid |
500 mg/125 mg |
Film-coated tablet |
Oral use |
Poland |
Mylan Ireland Limited |
|
Atorvagen |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Poland |
Mylan Ireland Limited |
|
Atorvagen |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Poland |
Mylan Ireland Limited |
|
Atorvagen |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Poland |
Artespharm Sp. z o.o. |
|
Atostat |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Poland |
Artespharm Sp. z o.o. |
|
Atostat |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Poland |
Artespharm Sp. z o.o. |
|
Atostat |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Poland |
Artespharm Sp. z o.o. |
|
Atostat |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Poland |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Poland |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Poland |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Poland |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
Poland |
Brillpharma (Ireland) Limited |
|
Ibuprofen Bril |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Poland |
US Pharmacia Sp. z o.o. |
|
Ibuprom Ultramax Sprint |
Ibuprofen |
600 mg |
Capsule, soft |
Oral use |
Poland |
US Pharmacia Sp. z o.o. |
|
Ibuprom Zatoki Sprint |
Ibuprofen/pseudoephedrine |
200 mg/30 mg |
Capsule, soft |
Oral use |
Poland |
|
Synoptis Pharma Sp. z o.o. |
Ifedrin ZATOKI APTEO MED |
Ibuprofen/pseudoephedrine |
200 mg/30 mg |
Capsule, soft |
Oral use |
Portugal |
Laboratórios Basi — Indústria Farmacêutica, S.A |
|
Amoxicilina + Ácido Clavulânico Basi |
Amoxicillin/ clavulanic acid |
250 mg/5 ml +62,5 mg/5 ml |
Powder for oral suspension |
Oral use |
Portugal |
Laboratórios Basi — Indústria Farmacêutica, S.A |
|
Amoxicilina + Ácido Clavulânico Basi |
Amoxicillin/ clavulanic acid |
400 mg/5 ml + 57 mg/5 ml |
Powder for oral suspension |
Oral use |
Portugal |
Mylan Lda |
|
Atorvastatine Mylan |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Portugal |
Mylan Lda |
|
Atorvastatine Mylan |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Portugal |
Mylan Lda |
|
Atorvastatine Mylan |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Portugal |
Mylan Lda |
|
Atorvastatine Mylan |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Portugal |
Mylan Lda |
|
Efavirenz Mylan |
Efavirenz |
600 mg |
Film-coated tablet |
Oral use |
Portugal |
Abdi Farma Unipessoal Limitada |
|
Etolyn |
Etodolac |
600 mg |
Prolonged-release tablet |
Oral use |
Portugal |
STADA Lda. |
|
Pramolix 500 mg cápsula mole |
Paracetamol |
500 mg |
Capsule, soft |
Oral use |
Portugal |
Laboratórios Azevedos — Indústria Farmacêutica, S.A. |
|
Algik Gripe |
Paracetamol/pseudoephedrine |
500 mg/30 mg |
Capsule, soft |
Oral use |
Portugal |
Mylan, Lda. |
|
Pioglitazona Mylan |
Pioglitazone |
15 mg |
Tablet |
Oral use |
Portugal |
Mylan, Lda. |
|
Pioglitazona Mylan |
Pioglitazone |
30 mg |
Tablet |
Oral use |
Portugal |
Mylan, Lda. |
|
Pioglitazona Mylan |
Pioglitazone |
45 mg |
Tablet |
Oral use |
Portugal |
Alter, S.A. |
|
Rosuvastatina + Ezetimiba Alter |
Rosuvastatin/ezetimibe |
5 mg/10 mg |
Film-coated tablet |
Oral use |
Portugal |
Alter, S.A. |
|
Rosuvastatina + Ezetimiba Alter |
Rosuvastatin/ezetimibe |
10 mg/10 mg |
Film-coated tablet |
Oral use |
Portugal |
Alter, S.A. |
|
Rosuvastatina + Ezetimiba Alter |
Rosuvastatin/ezetimibe |
20 mg/10 mg |
Film-coated tablet |
Oral use |
Portugal |
Alter, S.A. |
|
Rosuvastatina + Ezetimiba Alter |
Rosuvastatin/ezetimibe |
40 mg/10 mg |
Film-coated tablet |
Oral use |
Portugal |
Farmalter — Produtos Farmacêuticos e Dietéticos, Lda. |
|
Rosuvastatina + Ezetimiba Bistenibe |
Rosuvastatin/ezetimibe |
5 mg/10 mg |
Film-coated tablet |
Oral use |
Portugal |
Farmalter — Produtos Farmacêuticos e Dietéticos, Lda. |
|
Rosuvastatina + Ezetimiba Bistenibe |
Rosuvastatin/ezetimibe |
10 mg/10 mg |
Film-coated tablet |
Oral use |
Portugal |
Farmalter — Produtos Farmacêuticos e Dietéticos, Lda. |
|
Rosuvastatina + Ezetimiba Bistenibe |
Rosuvastatin/ezetimibe |
20 mg/10 mg |
Film-coated tablet |
Oral use |
Portugal |
Farmalter — Produtos Farmacêuticos e Dietéticos, Lda. |
|
Rosuvastatina + Ezetimiba Bistenibe |
Rosuvastatin/ezetimibe |
40 mg/10 mg |
Film-coated tablet |
Oral use |
Romania |
S.C. Sandoz SRL |
|
ALFACALCIDOL SANDOZ 0,25 μg |
Alfacalcidol |
0,25 mg |
Capsule, soft |
Oral use |
Romania |
S.C. Sandoz SRL |
|
ALFACALCIDOL SANDOZ 0,5 μg |
Alfacalcidol |
0,5 mg |
Capsule, soft |
Oral use |
Romania |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen STRIDES |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Romania |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen STRIDES |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Romania |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen STRIDES |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Romania |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen STRIDES |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
Romania |
|
STADA Arzneimittel AG |
IBUPROFEN/ PARACETAMOL 200 mg/500 mg |
Ibuprofen/paracetamol |
200 mg/500 mg |
Capsule, soft |
Oral use |
Romania |
|
PharmaMatch B.V. |
Buprofess raceala si Gripa |
Ibuprofen/pseudoephedrine |
200 mg/30 mg |
Capsule, soft |
Oral use |
Slovakia |
Sandoz Pharmaceuticals d.d. |
|
Alfakalcidol SANDOZ 1 mikrogram mäkké kapsuly |
Alfacalcidol |
1 mcg |
Capsule, soft |
Oral use |
Slovakia |
Mylan Ireland Limited |
|
Atorvastatine Mylan |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Slovakia |
Mylan Ireland Limited |
|
Atorvastatine Mylan |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Slovakia |
|
STADA Arzneimittel AG |
Ibumol |
Ibuprofen/paracetamol |
200 mg/500 mg |
Capsule, soft |
Oral use |
Slovakia |
STADA Arzneimittel AG |
|
Parastad mäkké kapsuly |
Paracetamol |
500 mg |
Capsule, soft |
Oral use |
Slovenia |
Mylan Ireland Limited |
|
Atorvastatin Mylan |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Slovenia |
Mylan Ireland Limited |
|
Atorvastatin Mylan |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Slovenia |
Mylan Ireland Limited |
|
Atorvastatin Mylan |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Slovenia |
|
STADA Arzneimittel AG |
Ibumol |
Ibuprofen/paracetamol |
200 mg/500 mg |
Capsule, soft |
Oral use |
Spain |
Mylan Pharmaceuticals, S.L. |
|
ATORVASTATINA MYLAN 10 mg comprimidos recubiertos con película EFG |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Spain |
Mylan Pharmaceuticals, S.L. |
|
ATORVASTATINA MYLAN 20 mg comprimidos recubiertos con película EFG |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Spain |
Mylan Pharmaceuticals, S.L. |
|
ATORVASTATINA MYLAN 40 mg comprimidos recubiertos con película EFG |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Spain |
Mylan Pharmaceuticals, S.L. |
|
ATORVASTATINA MYLAN 80 mg comprimidos recubiertos con película EFG |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Spain |
Tarbis Farma, S.L. |
|
ATORVASTATINA TARBIS FARMA 10 mg comprimidos recubiertos con película EFG |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Spain |
Tarbis Farma, S.L. |
|
ATORVASTATINA TARBIS FARMA 20 mg comprimidos recubiertos con película EFG |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Spain |
Tarbis Farma, S.L. |
|
ATORVASTATINA TARBIS FARMA 40 mg comprimidos recubiertos con película EFG |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Spain |
Tarbis Farma, S.L. |
|
ATORVASTATINA TARBIS FARMA 80 mg comprimidos recubiertos con película EFG |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Spain |
Johnson and Johnson, S.A. |
|
INISTON TUSIV 15 mg solución oral en sobre |
Dextromethorphan |
15 mg/5 ml |
Oral solution in sachet |
Oral use |
Spain |
Mylan Pharmaceutica LS, S.L. |
|
EFAVIRENZ MYLAN 600 mg comprimidos recubiertos con película EFG |
Efavirenz |
600 mg |
Film-coated tablet |
Oral use |
Spain |
|
Fair-med Healthcare GmbH |
IBUPROFEN FMH 200 mg comprimidos recubiertos con película EFG |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Spain |
|
Fair-med Healthcare GmbH |
IBUPROFEN FMH 400 mg comprimidos recubiertos con película EFG |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Spain |
|
Fair-med Healthcare GmbH |
IBUPROFEN FMH 600 mg comprimidos recubiertos con película EFG |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Spain |
|
Fair-med Healthcare GmbH |
IBUPROFEN FMH 800 mg comprimidos recubiertos con película EFG |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
Spain |
|
Laboratorios Tillomed Spain S.L.U. |
PALIPERIDONA TILLOMED 3 mg comprimidos de liberación controlada |
Paliperidone |
3 mg |
Prolonged-release tablet |
Oral use |
Spain |
|
Laboratorios Tillomed Spain S.L.U. |
PALIPERIDONA TILLOMED 6 mg comprimidos de liberación controlada |
Paliperidone |
6 mg |
Prolonged-release tablet |
Oral use |
Spain |
|
Laboratorios Tillomed Spain S.L.U. |
PALIPERIDONA TILLOMED 9 mg comprimidos de liberación controlada |
Paliperidone |
9 mg |
Prolonged-release tablet |
Oral use |
Spain |
|
Theramex Ireland Limited |
OVALUTE 100 mg cápsulas blandas |
Progesterone |
100 mg |
Capsule, soft |
Oral use |
Spain |
Aurovitas Spain, S.A.U. |
|
TRAMADOL/PARACETAMOL AUROVITAS SPAIN 37,5 mg/325 mg comprimidos recubiertos con película EFG |
Tramadol/paracetamol |
37,5 mg/325 mg |
Film-coated tablet |
Oral use |
Sweden |
Orifarm Generics A/S |
|
Alfacalcidol Orifarm |
Alfacalcidol |
0,25 mcg |
Capsule, soft |
Oral use |
Sweden |
Orifarm Generics A/S |
|
Alfacalcidol Orifarm |
Alfacalcidol |
0,5 mcg |
Capsule, soft |
Oral use |
Sweden |
Orifarm Generics A/S |
|
Alfacalcidol Orifarm |
Alfacalcidol |
1 mcg |
Capsule, soft |
Oral use |
Sweden |
Mylan AB |
|
Atorvastatin Mylan |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Sweden |
Mylan AB |
|
Atorvastatin Mylan |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Sweden |
Mylan AB |
|
Atorvastatin Mylan |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Sweden |
Mylan AB |
|
Atorvastatin Mylan |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Sweden |
Amarox Pharma B.V. |
|
Atorvastatin Amarox |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
Sweden |
Amarox Pharma B.V. |
|
Atorvastatin Amarox |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
Sweden |
Amarox Pharma B.V. |
|
Atorvastatin Amarox |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
Sweden |
Amarox Pharma B.V. |
|
Atorvastatin Amarox |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
Sweden |
Sandoz A/S |
|
Flucloxacillin Sandoz |
Flucloxacillin |
500 mg |
Film-coated tablet |
Oral use |
Sweden |
Sandoz A/S |
|
Flucloxacillin Sandoz |
Flucloxacillin |
750 mg |
Film-coated tablet |
Oral use |
Sweden |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Sweden |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Sweden |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Sweden |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
Sweden |
Brillpharma (Ireland) Limited |
|
Ibuprofen Bril |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Sweden |
Brillpharma (Ireland) Limited |
|
Ibuprofen Bril |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Sweden |
Brillpharma (Ireland) Limited |
|
Ibuprofen Bril |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Sweden |
Brillpharma (Ireland) Limited |
|
Ibuprofen BrillPharma |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
Sweden |
Brillpharma (Ireland) Limited |
|
Ibuprofen BrillPharma |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
Sweden |
Brillpharma (Ireland) Limited |
|
Ibuprofen BrillPharma |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
Sweden |
Orifarm Generics A/S |
|
Isonova |
Isosorbide mononitrate |
30 mg |
Prolonged-release tablet |
Oral use |
Sweden |
Orifarm Generics A/S |
|
Isonova |
Isosorbide mononitrate |
60 mg |
Prolonged-release tablet |
Oral use |
Sweden |
Aristo Pharma GmbH |
|
Kagitz |
Quetiapine |
50 mg |
Prolonged-release tablet |
Oral use |
Sweden |
Aristo Pharma GmbH |
|
Kagitz |
Quetiapine |
300 mg |
Prolonged-release tablet |
Oral use |
Sweden |
Aristo Pharma GmbH |
|
Kagitz |
Quetiapine |
400 mg |
Prolonged-release tablet |
Oral use |
The Netherlands |
Mylan B.V. |
|
Atorvastatine Mylan 10 mg, filmomhulde tabletten |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
The Netherlands |
Mylan B.V. |
|
Atorvastatine Mylan 20 mg, filmomhulde tabletten |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
The Netherlands |
Mylan B.V. |
|
Atorvastatine Mylan 40 mg, filmomhulde tabletten |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
The Netherlands |
Mylan B.V. |
|
Atorvastatine Mylan 80 mg, filmomhulde tabletten |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
The Netherlands |
Amarox Pharma B.V. |
|
Atorvastatine Amarox 10 mg filmomhulde tabletten |
Atorvastatin |
10 mg |
Film-coated tablet |
Oral use |
The Netherlands |
Amarox Pharma B.V. |
|
Atorvastatine Amarox 20 mg filmomhulde tabletten |
Atorvastatin |
20 mg |
Film-coated tablet |
Oral use |
The Netherlands |
Amarox Pharma B.V. |
|
Atorvastatine Amarox 40 mg filmomhulde tabletten |
Atorvastatin |
40 mg |
Film-coated tablet |
Oral use |
The Netherlands |
Amarox Pharma B.V. |
|
Atorvastatine Amarox 80 mg filmomhulde tabletten |
Atorvastatin |
80 mg |
Film-coated tablet |
Oral use |
The Netherlands |
Sandoz B.V. |
|
Clobazam Sandoz 10 mg, tabletten |
Clobazam |
10 mg |
Tablet |
Oral use |
The Netherlands |
TioFarma B.V. |
|
Clobazam Tiofarma 10 mg, tabletten |
Clobazam |
10 mg |
Tablet |
Oral use |
The Netherlands |
TioFarma B.V. |
|
Clobazam Tiofarma 20 mg, tabletten |
Clobazam |
20 mg |
Tablet |
Oral use |
The Netherlands |
Sandoz B.V. |
|
Clonazepam Sandoz 0,5 mg, tabletten |
Clonazepam |
0,5 mg |
Tablet |
Oral use |
The Netherlands |
Sandoz B.V. |
|
Clonazepam Sandoz 2 mg, tabletten |
Clonazepam |
2 mg |
Tablet |
Oral use |
The Netherlands |
TioFarma B.V. |
|
Clonazepam Tiofarma 0,5 mg, tabletten |
Clonazepam |
0,5 mg |
Tablet |
Oral use |
The Netherlands |
TioFarma B.V. |
|
Clonazepam Tiofarma 2 mg, tabletten |
Clonazepam |
2 mg |
Tablet |
Oral use |
The Netherlands |
Mylan B.V. |
|
Efavirenz Mylan 600 mg, filmomhulde tabletten |
Efavirenz |
600 mg |
Film-coated tablet |
Oral use |
The Netherlands |
Tillomed Pharma GmbH |
|
Ezetimibe/Simvastatine Tillomed 10 mg/10 mg, tabletten |
Ezetimibe/simvastatin |
10 mg/10 mg |
Tablet |
Oral use |
The Netherlands |
Tillomed Pharma GmbH |
|
Ezetimibe/Simvastatine Tillomed 10 mg/20 mg, tabletten |
Ezetimibe/simvastatin |
10 mg/20 mg |
Tablet |
Oral use |
The Netherlands |
Tillomed Pharma GmbH |
|
Ezetimibe/Simvastatine Tillomed 10 mg/40 mg, tabletten |
Ezetimibe/simvastatin |
10 mg/40 mg |
Tablet |
Oral use |
The Netherlands |
Tillomed Pharma GmbH |
|
Ezetimibe/Simvastatine Tillomed 10 mg/80 mg, tabletten |
Ezetimibe/simvastatin |
10 mg/80 mg |
Tablet |
Oral use |
The Netherlands |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides 200 mg, filmomhulde tabletten |
Ibuprofen |
200 mg |
Film-coated tablet |
Oral use |
The Netherlands |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides 200 mg, filmomhulde tabletten |
Ibuprofen |
400 mg |
Film-coated tablet |
Oral use |
The Netherlands |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides 200 mg, filmomhulde tabletten |
Ibuprofen |
600 mg |
Film-coated tablet |
Oral use |
The Netherlands |
|
Strides Pharma (Cyprus) Limited |
Ibuprofen Strides 200 mg, filmomhulde tabletten |
Ibuprofen |
800 mg |
Film-coated tablet |
Oral use |
The Netherlands |
RIA Generics Limited |
|
Nortriptyline RIA 10 mg tabletten |
Nortriptyline |
10 mg |
Tablet |
Oral use |
The Netherlands |
RIA Generics Limited |
|
Nortriptyline RIA 25 mg tabletten |
Nortriptyline |
25 mg |
Tablet |
Oral use |
The Netherlands |
|
Tillomed Pharma GmbH |
Paliperidon Tillomed 3 mg, tabletten met verlengde afgifte |
Paliperidone |
3 mg |
Prolonged-release tablet |
Oral use |
The Netherlands |
|
Tillomed Pharma GmbH |
Paliperidon Tillomed 6 mg, tabletten met verlengde afgifte |
Paliperidone |
6 mg |
Prolonged-release tablet |
Oral use |
The Netherlands |
|
Tillomed Pharma GmbH |
Paliperidon Tillomed 9 mg, tabletten met verlengde afgifte |
Paliperidone |
9 mg |
Prolonged-release tablet |
Oral use |
The Netherlands |
Healthypharm B.V. |
|
Paracetamol liquid caps HTP 500 mg, zachte capsules |
Paracetamol |
500 mg |
Capsule, soft |
Oral use |
The Netherlands |
MAE Holding B.V. |
|
Paracetamol Linn 500 mg liquid caps, zachte capsules |
Paracetamol |
500 mg |
Capsule, soft |
Oral use |
The Netherlands |
|
Socium Pharma B.V. |
Paracetamol/Ibuprofen Socium 500/200 mg zachte capsules |
Paracetamol/ibuprofen |
500 mg / 200 mg |
Capsule, soft |
Oral use |
The Netherlands |
|
Theramex Ireland Limited |
Ovalute 100 mg, zachte capsule |
Progesterone |
100 mg |
Capsule, soft |
Oral use |
The Netherlands |
|
Theramex Ireland Limited |
Ovalute 200 mg, zachte capsule |
Progesterone |
200 mg |
Capsule, soft |
Oral use |
The Netherlands |
RIA Generics Limited |
|
Sertraline RIA 50 mg, filmomhulde tabletten |
Sertraline |
50 mg |
Film-coated tablet |
Oral use |
The Netherlands |
RIA Generics Limited |
|
Sertraline RIA 100 mg, filmomhulde tabletten |
Sertraline |
100 mg |
Film-coated tablet |
Oral use |
The Netherlands |
Mylan B.V. |
|
Zolmitriptan Mylan 2,5 mg, orodispergeerbare tabletten |
Zolmitriptan |
2,5 mg |
Orodispersible tablet |
Oral use |
The Netherlands |
Mylan B.V. |
|
Zolmitriptan Mylan 5 mg, orodispergeerbare tabletten |
Zolmitriptan |
5 mg |
Orodispersible tablet |
Oral use |
United Kingdom (Northern Ireland) |
Strandhaven Limited |
|