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, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Date: 2022-12-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product








C_2022496EN.01001201.xml










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.

(2)  OJ L 311, 28.11.2001, p. 1.

(3)  OJ L 4, 7.1.2019, p. 43.




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


 


Amlodipine 5 mg Tablets


Amlodipine


5 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


Strandhaven Limited


 


Amlodipine 10 mg Tablets


Amlodipine


10 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


Wockhardt UK Limited


 


Amlodipine 5 mg Tablets


Amlodipine


5 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


Wockhardt UK Limited


 


Amlodipine 10 mg Tablets


Amlodipine


10 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


Accord Healthcare Limited


 


Amoxicillin 250 mg Capsules


Amoxicillin


250 mg


Capsule, hard


Oral use




United Kingdom (Northern Ireland)


Accord Healthcare Limited


 


Amoxicillin 500 mg Capsules


Amoxicillin


500 mg


Capsule, hard


Oral use




United Kingdom (Northern Ireland)


Medreich PLC


 


Amoxicillin 250 mg Capsules


Amoxicillin


250 mg


Capsule, hard


Oral use




United Kingdom (Northern Ireland)


Medreich PLC


 


Amoxicillin 500 mg Capsules


Amoxicillin


500 mg


Capsule, hard


Oral use




United Kingdom (Northern Ireland)


Medreich PLC


 


Co-Amoxiclav 250/62.5 mg Powder for Oral Suspension


Amoxicillin/ clavulanic acid


250 mg/62,5  mg


Powder for oral suspension


Oral use




United Kingdom (Northern Ireland)


Medreich PLC


 


Co-Amoxiclav 457/5 ml Suspension


Amoxicillin/ clavulanic acid


457 mg/5 ml


Powder for oral suspension


Oral use




United Kingdom (Northern Ireland)


Medreich PLC


 


Co-Amoxiclav 500/125 mg Tablets


Amoxicillin/ clavulanic acid


500 mg/125 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


Generics Ltd


 


Atorvastatine Mylan


Atorvastatin


10 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Generics Ltd


 


Atorvastatine Mylan


Atorvastatin


20 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Generics Ltd


 


Atorvastatine Mylan


Atorvastatin


40 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Generics Ltd


 


Atorvastatine Mylan


Atorvastatin


80 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Wockhardt UK Limited


 


Atorvastatin 80 mg film-coated Tablets


Atorvastatin


80 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Wockhardt UK Limited


 


Atorvastatin 10 mg film-coated Tablets


Atorvastatin


10 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Wockhardt UK Limited


 


Atorvastatin 20 mg film-coated Tablets


Atorvastatin


20 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Wockhardt UK Limited


 


Atorvastatin 40 mg film-coated Tablets


Atorvastatin


40 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Amarox Limited


 


Atorvastatin 10 mg film-coated Tablets


Atorvastatin


10 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Amarox Limited


 


Atorvastatin 20 mg film-coated Tablets


Atorvastatin


20 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Amarox Limited


 


Atorvastatin 40 mg film-coated Tablets


Atorvastatin


40 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Amarox Limited


 


Atorvastatin 80 mg film-coated Tablets


Atorvastatin


80 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Morningside Healthcare Limited


 


Clonidine hydrochloride 25 microgram Tablets


Clonidine


25 mcg


Tablet


Oral use




United Kingdom (Northern Ireland)


Generics Limited


 


Efavirenz 600 mg film-coated Tablets


Efavirenz


600 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Brown & Burk UK Limited


 


Ethambutol 100 mg film-coated Tablets


Ethambutol


100 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Brown & Burk UK Limited


 


Ethambutol 400 mg film-coated Tablets


Ethambutol


400 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Abdi Farma Unipessoal Limitada


 


Etolyn 600 mg Prolonged-Release Tablets


Etodolac


600 mg


Prolonged-release tablet


Oral use




United Kingdom (Northern Ireland)


Medreich PLC


 


Flucloxacillin 250 mg Capsules


Flucloxacillin


250 mg


Capsule, hard


Oral use




United Kingdom (Northern Ireland)


Medreich PLC


 


Flucloxacillin 500 mg Capsules


Flucloxacillin


500 mg


Capsule, hard


Oral use




United Kingdom (Northern Ireland)


Brown & Burk UK Limited


 


Gliclazide 30 mg Prolonged-Release Tablets


Gliclazide


30 mg


Prolonged-release tablet


Oral use




United Kingdom (Northern Ireland)


Brown & Burk UK Limited


 


Gliclazide 40 mg Prolonged-Release Tablets


Gliclazide


40 mg


Prolonged-release tablet


Oral use




United Kingdom (Northern Ireland)


Brown & Burk UK Limited


 


Gliclazide 60 mg Prolonged-Release Tablets


Gliclazide


60 mg


Prolonged-release tablet


Oral use




United Kingdom (Northern Ireland)


 


Blackrock Pharmaceuticals Limited


Hydrocortisone 10 mg Tablets


Hydrocortisone


10 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


 


Blackrock Pharmaceuticals Limited


Hydrocortisone 20 mg Tablets


Hydrocortisone


20 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


Silicon Pharma Limited


 


Hydrocortisone 10 mg Tablets


Hydrocortisone


10 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


Silicon Pharma Limited


 


Hydrocortisone 20 mg Tablets


Hydrocortisone


20 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


 


Strides Pharma UK Limited


Ibuprofen 200 mg film-coated Tablets


Ibuprofen


200 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


 


Strides Pharma UK Limited


Ibuprofen 400 mg film-coated Tablets


Ibuprofen


400 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


 


Strides Pharma UK Limited


Ibuprofen 600 mg film-coated Tablets


Ibuprofen


600 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


 


Socium Pharma B.V.


Ibuprofen/Pseudoephadrine HCl 200/30 mg Capsules, soft


Ibuprofen/pseudoephedrine


200 mg/30 mg


Capsule, soft


Oral use




United Kingdom (Northern Ireland)


 


Strides Pharma UK Limited


Liothyronine sodium 5 microgram Tablets


Liothyronine


5 mcg


Tablet


Oral use




United Kingdom (Northern Ireland)


 


Strides Pharma UK Limited


Liothyronine sodium 20 microgram Tablets


Liothyronine


20 mcg


Tablet


Oral use




United Kingdom (Northern Ireland)


Zentiva Pharma UK Limited


 


Memantine hydrochloride 5 mg + 10 mg + 15 mg + 20 mg Soluble Tablets


Memantine


5 mg + 10 mg + 15 mg + 20 mg


Soluble tablet


Oral use




United Kingdom (Northern Ireland)


Zentiva Pharma UK Limited


 


Memantine hydrochloride 10 mg Soluble Tablets


Memantine


10 mg


Soluble tablet


Oral use




United Kingdom (Northern Ireland)


Zentiva Pharma UK Limited


 


Memantine hydrochloride 20 mg Soluble Tablets


Memantine


20 mg


Soluble tablet


Oral use




United Kingdom (Northern Ireland)


Colonis Pharma Limited


 


Metformin Colonis 500mg/5ml Oral Solution


Metformin


500 mg


Oral solution


Oral use




United Kingdom (Northern Ireland)


Colonis Pharma Limited


 


Metformin Colonis 850mg/5ml Oral Solution


Metformin


850 mg


Oral solution


Oral use




United Kingdom (Northern Ireland)


Colonis Pharma Limited


 


Metformin Colonis 1 000  mg/5ml Oral Solution


Metformin


1 000  mg/5 ml


Oral solution


Oral use




United Kingdom (Northern Ireland)


Mercury Pharmaceuticals Limited


 


Nebivolol 2.5 mg Tablets


Nebivolol


2,5  mg


Tablet


Oral use




United Kingdom (Northern Ireland)


Mercury Pharmaceuticals Limited


 


Nebivolol 5 mg Tablets


Nebivolol


5 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


RIA Generics Limited


 


Nefopam hydrochloride 30 mg film-coated Tablets


Nefopam


30 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


RIA Generics Limited


 


Nefopam hydrochloride 30 mg film-coated Tablets


Nefopam


30 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Zentiva Pharma UK Limited


 


Nevirapine Amneal 400 mg Prolonged-Release Tablets


Nevirapine


400 mg


Prolonged-Release Tablet


Oral use




United Kingdom (Northern Ireland)


RIA Generics Limited


 


Nortriptyline 10 mg Tablets


Nortriptyline


10 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


RIA Generics Limited


 


Nortriptyline 25 mg Tablets


Nortriptyline


25 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


RIA Generics Limited


 


Nortriptyline 10 mg Tablets


Nortriptyline


10 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


RIA Generics Limited


 


Nortriptyline 25 mg Tablets


Nortriptyline


25 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


 


Pharmamatch B.V.


Paracetamol 500 mg Capsules, soft


Paracetamol


500 mg


Capsule, soft


Oral use




United Kingdom (Northern Ireland)


 


Interdos Pharma B.V.


Paracetamol/Ibuprofen interdos 500/200 mg Caspules, soft


Paracetamol/Ibuprofen


500 mg / 200 mg


Capsule, soft


Oral use




United Kingdom (Northern Ireland)


 


Pharmamatch B.V.


Paracetamol/Ibuprofen 500/200 mg Caspules, soft


Paracetamol/Ibuprofen


500 mg / 200 mg


Capsule, soft


Oral use




United Kingdom (Northern Ireland)


Generics Limited


 


Pioglitazone 15 mg Tablets


Pioglitazone


15 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


Generics Limited


 


Pioglitazone 30 mg Tablets


Pioglitazone


30 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


Generics Limited


 


Pioglitazone 45 mg Tablets


Pioglitazone


45 mg


Tablet


Oral use




United Kingdom (Northern Ireland)


Brown & Burk UK Limited


 


Rosuvastatin 10 mg film-coated Tablets


Rosuvastatin


10 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Brown & Burk UK Limited


 


Rosuvastatin 20 mg film-coated Tablets


Rosuvastatin


20 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Brown & Burk UK Limited


 


Rosuvastatin 40 mg film-coated Tablets


Rosuvastatin


40 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


RIA Generics Limited


 


Sertraline 50 mg film-coated Tablets


Sertraline


50 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


RIA Generics Limited


 


Sertraline 100 mg film-coated Tablets


Sertraline


100 mg


Film-coated tablet


Oral use




United Kingdom (Northern Ireland)


Generics Limited


 


Zolmitriptan 2.5 mg Orodispersible Tablets


Zolmitriptan


2,5  mg


Orodispersible tablet


Oral use




United Kingdom (Northern Ireland)


Generics Limited


 


Zolmitriptan 5 mg Orodispersible Tablets


Zolmitriptan


5 mg


Orodispersible tablet


Oral use




United Kingdom (Northern Ireland)


Athlone Pharmaceuticals Limited


 


Zopiclone 7.5 mg Tablets


Zopiclone


7,5  mg


Tablet


Oral use