Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2016-10-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug, withdrawal from the market








C_2016399EN.01000901.xml










28.10.2016   


EN


Official Journal of the European Union


C 399/9





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2016/C 399/02)






—



Issuing, maintenance or modification of a national marketing authorization















Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




8.9.2016


Alkem Art 31


Not applicable


See Annex II


See Annex II


9.9.2016




22.9.2016


Durogesic and associated names — Art 30


fentanyl


See Annex III


See Annex III


23.9.2016




22.9.2016


Semler Art 31


Not applicable


See Annex IV


See Annex IV


23.9.2016










—



Refusal of a national marketing authorization















Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




22.9.2016


Diclofenac epolamine 50 mg tablets — Art 29


diclofenac


See Annex I


See Annex I


23.9.2016










—



Suspension of a national marketing authorization















Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




8.9.2016


Alkem Art 31


Not applicable


See Annex II


See Annex II


9.9.2016




22.9.2016


Semler Art 31


Not applicable


See Annex IV


See Annex IV


23.9.2016






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, applicants in the member states










Member State EU/EEA


Applicant company name, address


Invented Name


Strength


Pharmaceutical form


Route of administration




Czech Republic


ALTERGON ITALIA S.r.L
Via dell’Industria
83030 Pietradefusi, Avellino, ITALY


DICLOFENAC ALTERGON 50 MG TABLETY


50 mg


tablet


Oral use




France


ALTERGON ITALIA S.r.L
Via dell’Industria
83030 Pietradefusi, Avellino, ITALY


DICLOFENAC ALTERGON


50 mg


tablet


Oral use




Slovak Republic


ALTERGON ITALIA S.r.L
Via dell’Industria
83030 Pietradefusi, Avellino, ITALY


Diclofenac ALTERGON 50 mg


50 mg


tablet


Oral use




United Kingdom


ALTERGON ITALIA S.r.L
Via dell’Industria
83030 Pietradefusi, Avellino, ITALY


DICLOFENAC EPOLAMINE ALTERGON 50 MG TABLETS


50 mg


tablet


Oral use







ANNEX II
List of nationally authorised medicinal products and marketing authorisation applications

Annex IA: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established













Member State EU/EEA


Marketing Authorisation Holder


Applicant


Invented name


Active Substance


Strength


Pharmaceutical Form


Route of Administration




Austria


Krka d.d., Novo mesto


 


Cefuroxim Krka 250 mg Filmtabletten


Cefuroxime


250 mg


Film-coated tablet


Oral use




Austria


Krka d.d., Novo mesto


 


Cefuroxim Krka 500 mg Filmtabletten


Cefuroxime


500 mg


Film-coated tablet


Oral use




Bulgaria


Krka d.d., Novo mesto


 


Furocef 250 mg film-coated tablets


Cefuroxime


250 mg


Film-coated tablet


Oral use




Bulgaria


Krka d.d., Novo mesto


 


Furocef 500 mg film-coated tablets


Cefuroxime


500 mg


Film-coated tablet


Oral use




Croatia


Krka — farma d.o.o.


 


Furocef 250 mg film-coated tablets


Cefuroxime


250 mg


Film-coated tablet


Oral use




Croatia


Krka — farma d.o.o.


 


Furocef 500 mg film-coated tablets


Cefuroxime


500 mg


Film-coated tablet


Oral use




Czech Republic


Krka d.d., Novo mesto


 


Ricefan 250 mg


Cefuroxime


250 mg


Film-coated tablet


Oral use




Czech Republic


Krka d.d., Novo mesto


 


Ricefan 500 mg


Cefuroxime


500 mg


Film-coated tablet


Oral use




Estonia


Krka d.d., Novo mesto


 


FUROCEF


Cefuroxime


250 mg


Film-coated tablet


Oral use




Estonia


Krka d.d., Novo mesto


 


FUROCEF


Cefuroxime


500 mg


Film-coated tablet


Oral use




France


Krka d.d., Novo mesto


 


CEFUROXIME KRKA 250 mg, comprimé pelliculé


Cefuroxime


250 mg


Film-coated tablet


Oral use




France


Krka d.d., Novo mesto


 


CEFUROXIME KRKA 500 mg, comprimé pelliculé


Cefuroxime


500 mg


Film-coated tablet


Oral use




Germany


Alkem Pharma GmbH


 


Cefuroxim Alkem 250 mg Filmtabletten


Cefuroxime axetil


250 mg


Film-coated tablet


Oral use




Germany


Alkem Pharma GmbH


 


Cefuroxim Alkem 500 mg Filmtabletten


Cefuroxime axetil


500 mg


Film-coated tablet


Oral use




Hungary


Krka d.d., Novo mesto


 


Furocef Krka 250 mg tablets


Cefuroxime


250 mg


Tablet


Oral use




Hungary


Krka d.d., Novo mesto


 


Furocef Krka 500 mg tablets


Cefuroxime


500 mg


Tablet


Oral use




Latvia


Krka d.d., Novo mesto


 


Ricefan 250 mg film-coated tablets


Cefuroxime


250 mg


Film-coated tablet


Oral use




Latvia


Krka d.d., Novo mesto


 


Ricefan 500 mg film-coated tablets


Cefuroxime


500 mg


Film-coated tablet


Oral use




Lithuania


Krka d.d., Novo mesto


 


Ricefan


Cefuroxime


250 mg


Film-coated tablet


Oral use




Lithuania


Krka d.d., Novo mesto


 


Ricefan


Cefuroxime


500 mg


Film-coated tablet


Oral use




Lithuania


 


SIA Ingen Pharma


Cefuroxime Ingen Pharma


Cefuroxime


250 mg


Film-coated tablet


Oral use




Lithuania


 


SIA Ingen Pharma


Cefuroxime Ingen Pharma


Cefuroxime


500 mg


Film-coated tablet


Oral use




Poland


Krka d.d., Novo mesto


 


Furocef


Cefuroxime


250 mg


Film-coated tablet


Oral use




Poland


Krka d.d., Novo mesto


 


Furocef


Cefuroxime


500 mg


Film-coated tablet


Oral use




Portugal


Krka d.d., Novo mesto


 


Cefuroxima Krka


Cefuroxime axetil


250 mg


Film-coated tablet


Oral use




Portugal


Krka d.d., Novo mesto


 


Cefuroxima Krka


Cefuroxime axetil


500 mg


Film-coated tablet


Oral use




Romania


Krka d.d., Novo mesto


 


CEFUROXIME KRKA 250 mg, comprimate


Cefuroxime


250 mg


Film-coated tablet


Oral use




Romania


Krka d.d., Novo mesto


 


CEFUROXIME KRKA 500 mg, comprimate


Cefuroxime


500 mg


Film-coated tablet


Oral use




Slovak Republic


Krka d.d., Novo mesto


 


Furocef 250 mg filmom obalené tablety


Cefuroxime


250 mg


Film-coated tablet


Oral use




Slovak Republic


Krka d.d., Novo mesto


 


Furocef 500 mg filmom obalené tablety


Cefuroxime


500 mg


Film-coated tablet


Oral use




Slovenia


Krka d.d., Novo mesto


 


Ricefan


Cefuroxime


250 mg


Film-coated tablet


Oral use




Slovenia


Krka d.d., Novo mesto


 


Ricefan


Cefuroxime


500 mg


Film-coated tablet


Oral use




Spain


Alkem Pharma GmbH


 


Cefuroxima 500 mg comprimidos recubiertos con película


Cefuroxime axetil


500 mg


Film-coated tablet


Oral use




Spain


Alkem Pharma GmbH


 


Cefuroxima Alkem 250 mg comprimidos recubiertos con película


Cefuroxime axetil


250 mg


Film-coated tablet


Oral use




Spain


Krka d.d., Novo mesto


 


Cefuroxima KRKA 250 mg comprimidos recubiertos con película


Cefuroxime


250 mg


Film-coated tablet


Oral use




Spain


Krka d.d., Novo mesto


 


Cefuroxima KRKA 500 mg comprimidos recubiertos con película


Cefuroxime


500 mg


Film-coated tablet


Oral use




United Kingdom


Alkem Pharma GmbH


 


Cefuroxime 250 mg film-coated tablets


Cefuroxime axetil


250 mg


Film-coated tablet


Oral use




United Kingdom


Alkem Pharma GmbH


 


Cefuroxime 500 mg film-coated tablets


Cefuroxime axetil


500 mg


Film-coated tablet


Oral use





Annex IB: 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


Active Substance


Strength


Pharmaceutical Form


Route of Administration




Czech Republic


Alkem Pharma GmbH


 


Riluzole Alkem 50 mg potahované tablety


Riluzole


50 mg


Film-coated tablet


Oral use




Denmark


 


Orion Corporation


Ibuprofen Orion


Ibuprofen


200 mg


Film-coated tablet


Oral use




Denmark


 


Orion Corporation


Ibuprofen Orion


Ibuprofen


400 mg


Film-coated tablet


Oral use




Denmark


 


Orion Corporation


Ibuprofen Orion


Ibuprofen


600 mg


Film-coated tablet


Oral use




Germany


Alkem Pharma GmbH


 


Riluzol Alkem 50 mg Filmtabletten


Riluzole


50 mg


Film-coated tablet


Oral use




Spain


Alkem Pharma GmbH


 


Riluzole 50 mg comprimidos recubiertos con película EFG


Riluzole


50 mg


Film-coated tablet


Oral use




Sweden


 


Orion Corporation


Ibuprofen Orion


Ibuprofen


200 mg


Film-coated tablet


Oral use




Sweden


 


Orion Corporation


Ibuprofen Orion


Ibuprofen


400 mg


Film-coated tablet


Oral use




Sweden


 


Orion Corporation


Ibuprofen Orion


Ibuprofen


600 mg


Film-coated tablet


Oral use




United Kingdom


Alkem Pharma GmbH


 


Riluzole alkem 50 mg film-coated tablets


Riluzole


50 mg


Film-coated tablet


Oral use







ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES











Member State EU/EEA


Marketing authorisation holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration


Content (concentration)




Austria


Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B
Austria


Durogesic


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Austria


Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B
Austria


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Austria


Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B
Austria


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Austria


Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B
Austria


Durogesic


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Austria


Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B
Austria


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Belgium


Janssen-Cilag N.V.
Antwerpseweg 15-17
B-2340 Beerse
Belgium


Durogesic


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Belgium


Janssen-Cilag N.V.
Antwerpseweg 15-17
B-2340 Beerse
Belgium


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Belgium


Janssen-Cilag N.V.
Antwerpseweg 15-17
B-2340 Beerse
Belgium


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Belgium


Janssen-Cilag N.V.
Antwerpseweg 15-17
B-2340 Beerse
Belgium


Durogesic


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Belgium


Janssen-Cilag N.V.
Antwerpseweg 15-17
B-2340 Beerse
Belgium


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Croatia


Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia


Durogesic


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Croatia


Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Croatia


Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Croatia


Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia


Durogesic


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Croatia


Johnson & Johnson S.E. d.o.o. Oreškovićeva 6H, 10010 Zagreb, Croatia


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Cyprus


Janssen-Cilag International NV Turnhoutseweg 30
2340 Beerse Belgium


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Cyprus


Janssen-Cilag International NV Turnhoutseweg 30
2340 Beerse Belgium


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Cyprus


Janssen-Cilag International NV Turnhoutseweg 30
2340 Beerse Belgium


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Czech Republic


Janssen-Cilag s.r.o.,
Karla Engliše 3201/6,
Prague 5, 150 00
Czech Republic


Durogesic 12 mcg/h


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Czech Republic


Janssen-Cilag s.r.o.,
Karla Engliše 3201/6,
Prague 5, 150 00
Czech Republic


Durogesic 25 mcg/h


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Czech Republic


Janssen-Cilag s.r.o.,
Karla Engliše 3201/6,
Prague 5, 150 00
Czech Republic


Durogesic 50 mcg/h


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Czech Republic


Janssen-Cilag s.r.o.,
Karla Engliše 3201/6,
Prague 5, 150 00
Czech Republic


Durogesic 75 mcg/h


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Czech Republic


Janssen-Cilag s.r.o.,
Karla Engliše 3201/6,
Prague 5, 150 00
Czech Republic


Durogesic 100 mcg/h


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Denmark


Janssen Cilag A/S
Bregnerødvej 133
3460 Birkerød
Denmark


Durogesic


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Denmark


Janssen Cilag A/S
Bregnerødvej 133
3460 Birkerød
Denmark


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Denmark


Janssen Cilag A/S
Bregnerødvej 133
3460 Birkerød
Denmark


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Denmark


Janssen Cilag A/S
Bregnerødvej 133
3460 Birkerød
Denmark


Durogesic


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Denmark


Janssen Cilag A/S
Bregnerødvej 133
3460 Birkerød
Denmark


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Finland


Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo
Finland


Durogesic


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Finland


Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo
Finland


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Finland


Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo
Finland


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Finland


Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo
Finland


Durogesic


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Finland


Janssen-Cilag Oy, Vaisalantie 2, 02130 Espoo
Finland


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




France


JANSSEN-CILAG
1, rue Camille Desmoulins
TSA 91003
92787 ISSY-LES-MOULINEAUX Cedex 9
France


Durogesic 12 microgrammes/heure, dispositif transdermique


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




France


JANSSEN-CILAG
1, rue Camille Desmoulins
TSA 91003
92787 ISSY-LES-MOULINEAUX Cedex 9
France


Durogesic 25 microgrammes/heure, dispositif transdermique


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




France


JANSSEN-CILAG
1, rue Camille Desmoulins
TSA 91003
92787 ISSY-LES-MOULINEAUX Cedex 9
France


Durogesic 50 microgrammes/heure, dispositif transdermique


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




France


JANSSEN-CILAG
1, rue Camille Desmoulins
TSA 91003
92787 ISSY-LES-MOULINEAUX Cedex 9
France


Durogesic 75 microgrammes/heure, dispositif transdermique


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




France


JANSSEN-CILAG
1, rue Camille Desmoulins
TSA 91003
92787 ISSY-LES-MOULINEAUX Cedex 9
France


Durogesic 100 microgrammes/heure, dispositif transdermique


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Germany


JANSSEN-CILAG GmbH
Johnson & Johnson Platz 1
41470 Neuss, Germany


Durogesic SMAT


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Germany


JANSSEN-CILAG GmbH
Johnson & Johnson Platz 1
41470 Neuss, Germany


Durogesic SMAT


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Germany


JANSSEN-CILAG GmbH
Johnson & Johnson Platz 1
41470 Neuss, Germany


Durogesic SMAT


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Germany


JANSSEN-CILAG GmbH
Johnson & Johnson Platz 1
41470 Neuss, Germany


Durogesic SMAT


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Germany


JANSSEN-CILAG GmbH
Johnson & Johnson Platz 1
41470 Neuss, Germany


Durogesic SMAT


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Greece


Janssen-Cilag Pharmaceutical S.A.C.I.
56 Eirinis Ave.,
151 21, Pefki,
Greece


Durogesic


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Greece


Janssen-Cilag Pharmaceutical S.A.C.I.
56 Eirinis Ave.,
151 21, Pefki,
Greece


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Greece


Janssen-Cilag Pharmaceutical S.A.C.I.
56 Eirinis Ave.,
151 21, Pefki,
Greece


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Greece


Janssen-Cilag Pharmaceutical S.A.C.I.
56 Eirinis Ave.,
151 21, Pefki,
Greece


Durogesic


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Greece


Janssen-Cilag Pharmaceutical S.A.C.I.
56 Eirinis Ave.,
151 21, Pefki,
Greece


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Hungary


Janssen-Cilag Kft.
1123 Budapest,
Nagyenyed utca 8-14
Magyarország
Hungary


Durogesic 12 mikrogramm/óra transzdermális tapasz


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Hungary


Janssen-Cilag Kft.
1123 Budapest,
Nagyenyed utca 8-14
Magyarország
Hungary


Durogesic 25 mikrogramm/óra transzdermális tapasz


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Hungary


Janssen-Cilag Kft.
1123 Budapest,
Nagyenyed utca 8-14
Magyarország
Hungary


Durogesic 50 mikrogramm/óra transzdermális tapasz


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Hungary


Janssen-Cilag Kft.
1123 Budapest,
Nagyenyed utca 8-14
Magyarország
Hungary


Durogesic 75 mikrogramm/óra transzdermális tapasz


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Hungary


Janssen-Cilag Kft.
1123 Budapest,
Nagyenyed utca 8-14
Magyarország
Hungary


Durogesic 100 mikrogramm/óra transzdermális tapasz


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Iceland


Janssen-Cilag AB
Box 7073
192 07 Sollentuna
Sweden


Durogesic


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Iceland


Janssen-Cilag AB
Box 7073
192 07 Sollentuna
Sweden


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Iceland


Janssen-Cilag AB
Box 7073
192 07 Sollentuna
Sweden


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Iceland


Janssen-Cilag AB
Box 7073
192 07 Sollentuna
Sweden


Durogesic


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Iceland


Janssen-Cilag AB
Box 7073
192 07 Sollentuna
Sweden


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Ireland


Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
United Kingdom


Durogesic DTrans


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Ireland


Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
United Kingdom


Durogesic DTrans


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Ireland


Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
United Kingdom


Durogesic DTrans


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Ireland


Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
United Kingdom


Durogesic DTrans


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Ireland


Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
United Kingdom


Durogesic DTrans


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Italy


JANSSEN-CILAG SpA
Via M. Buonarroti, 23
20093 COLOGNO MONZESE (MI), Italy


Durogesic


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Italy


JANSSEN-CILAG SpA
Via M. Buonarroti, 23
20093 COLOGNO MONZESE (MI), Italy


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Italy


JANSSEN-CILAG SpA
Via M. Buonarroti, 23
20093 COLOGNO MONZESE (MI), Italy


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Italy


JANSSEN-CILAG SpA
Via M. Buonarroti, 23
20093 COLOGNO MONZESE (MI), Italy


Durogesic


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Italy


JANSSEN-CILAG SpA
Via M. Buonarroti, 23
20093 COLOGNO MONZESE (MI), Italy


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Luxembourg


Janssen-Cilag N.V.
Antwerpseweg 15-17
B-2340 Beerse
Belgium


Durogesic


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Luxembourg


Janssen-Cilag N.V.
Antwerpseweg 15-17
B-2340 Beerse
Belgium


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Luxembourg


Janssen-Cilag N.V.
Antwerpseweg 15-17
B-2340 Beerse
Belgium


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Luxembourg


Janssen-Cilag N.V.
Antwerpseweg 15-17
B-2340 Beerse
Belgium


Durogesic


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Luxembourg


Janssen-Cilag N.V.
Antwerpseweg 15-17
B-2340 Beerse
Belgium


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Malta


Janssen-Cilag International NV
Turnhoutseweg 30, 2340
Beerse
Belgium


Durogesic DTrans


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Malta


Janssen-Cilag International NV
Turnhoutseweg 30, 2340
Beerse
Belgium


Durogesic DTrans


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Malta


Janssen-Cilag International NV
Turnhoutseweg 30, 2340
Beerse
Belgium


Durogesic DTrans


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Malta


Janssen-Cilag International NV
Turnhoutseweg 30, 2340
Beerse
Belgium


Durogesic DTrans


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Malta


Janssen-Cilag International NV
Turnhoutseweg 30, 2340
Beerse
Belgium


Durogesic DTrans


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Netherlands


Janssen-Cilag B.V.
Dr. Paul Janssenweg 150
5026 RH Tilburg
PO Box 90240
5000 LT Tilburg
Netherlands


Durogesic 12 μg/uur


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Netherlands


Janssen-Cilag B.V.
Dr. Paul Janssenweg 150
5026 RH Tilburg
PO Box 90240
5000 LT Tilburg
Netherlands


Durogesic 25 μg/uur


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Netherlands


Janssen-Cilag B.V.
Dr. Paul Janssenweg 150
5026 RH Tilburg
PO Box 90240
5000 LT Tilburg
Netherlands


Durogesic 50 μg/uur


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Netherlands


Janssen-Cilag B.V.
Dr. Paul Janssenweg 150
5026 RH Tilburg
PO Box 90240
5000 LT Tilburg
Netherlands


Durogesic 75 μg/uur


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Netherlands


Janssen-Cilag B.V.
Dr. Paul Janssenweg 150
5026 RH Tilburg
PO Box 90240
5000 LT Tilburg
Netherlands


Durogesic 100 μg/uur


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Norway


Janssen-Cilag AS
Drammensveien 288
NO-0283 Oslo
Norway


Durogesic


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Norway


Janssen-Cilag AS
Drammensveien 288
NO-0283 Oslo
Norway


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Norway


Janssen-Cilag AS
Drammensveien 288
NO-0283 Oslo
Norway


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Norway


Janssen-Cilag AS
Drammensveien 288
NO-0283 Oslo
Norway


Durogesic


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Norway


Janssen-Cilag AS
Drammensveien 288
NO-0283 Oslo
Norway


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Poland


Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium


Durogesic


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Poland


Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Poland


Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Poland


Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium


Durogesic


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Poland


Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Portugal


Janssen Farmacêutica Portugal, Lda.
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
2734-503 Barcarena
Portugal


Durogesic


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Portugal


Janssen Farmacêutica Portugal, Lda.
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
2734-503 Barcarena
Portugal


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Portugal


Janssen Farmacêutica Portugal, Lda.
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
2734-503 Barcarena
Portugal


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Portugal


Janssen Farmacêutica Portugal, Lda.
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
2734-503 Barcarena
Portugal


Durogesic


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Portugal


Janssen Farmacêutica Portugal, Lda.
Estrada Consiglieri Pedroso, 69 A
Queluz de Baixo
2734-503 Barcarena
Portugal


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Slovenia


Johnson & Johnson d.o.o.
Šmartinska cesta 53,
1000 Ljubljana
Slovenia


Durogesic


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Slovenia


Johnson & Johnson d.o.o.
Šmartinska cesta 53,
1000 Ljubljana
Slovenia


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Slovenia


Johnson & Johnson d.o.o.
Šmartinska cesta 53,
1000 Ljubljana
Slovenia


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Slovenia


Johnson & Johnson d.o.o.
Šmartinska cesta 53,
1000 Ljubljana
Slovenia


Durogesic


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Slovenia


Johnson & Johnson d.o.o.
Šmartinska cesta 53,
1000 Ljubljana
Slovenia


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Spain


JANSSEN-CILAG, S.A.
Paseo de Las Doce Estrellas, 5-7
28042, Madrid
Spain


Durogesic Matrix


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Spain


JANSSEN-CILAG, S.A.
Paseo de Las Doce Estrellas, 5-7
28042, Madrid
Spain


Durogesic Matrix


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Spain


JANSSEN-CILAG, S.A.
Paseo de Las Doce Estrellas, 5-7
28042, Madrid
Spain


Durogesic Matrix


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Spain


JANSSEN-CILAG, S.A.
Paseo de Las Doce Estrellas, 5-7
28042, Madrid
Spain


Durogesic Matrix


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Spain


JANSSEN-CILAG, S.A.
Paseo de Las Doce Estrellas, 5-7
28042, Madrid
Spain


Durogesic Matrix


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




Sweden


Janssen-Cilag AB
Box 7073
192 07 Sollentuna
Sweden


Durogesic


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




Sweden


Janssen-Cilag AB
Box 7073
192 07 Sollentuna
Sweden


Durogesic


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




Sweden


Janssen-Cilag AB
Box 7073
192 07 Sollentuna
Sweden


Durogesic


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




Sweden


Janssen-Cilag AB
Box 7073
192 07 Sollentuna
Sweden


Durogesic


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




Sweden


Janssen-Cilag AB
Box 7073
192 07 Sollentuna
Sweden


Durogesic


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour




United Kingdom


Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
United Kingdom


Durogesic DTrans


12 μg/h


Transdermal patch


Transdermal use


2,1  mg/5,25  cm2 which release 12,5  μg fentanyl per hour




United Kingdom


Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
United Kingdom


Durogesic DTrans


25 μg/h


Transdermal patch


Transdermal use


4,2  mg/10,5  cm2 which release 25 μg fentanyl per hour




United Kingdom


Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
United Kingdom


Durogesic DTrans


50 μg/h


Transdermal patch


Transdermal use


8,4  mg/21 cm2 which release 50 μg fentanyl per hour




United Kingdom


Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
United Kingdom


Durogesic DTrans


75 μg/h


Transdermal patch


Transdermal use


12,6  mg/31,5  cm2 which release 75 μg fentanyl per hour




United Kingdom


Janssen-Cilag Limited
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
United Kingdom


Durogesic DTrans


100 μg/h


Transdermal patch


Transdermal use


16,8  mg/42 cm2 which release 100 μg fentanyl per hour







ANNEX IV
List of nationally authorised medicinal products and marketing authorisation applications

Annex IA: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established













Member State EU/EEA


Marketing Authorisation Holder


Applicant


Invented name


Active Substance


Strength


Pharmaceutical Form


Route of Administration




Austria


 


Lupin (Europe) Ltd


Abacavir/Lamivudin Aristo 600 mg/300 mg Filmtabletten


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Austria


 


Lupin (Europe) Ltd


Abacavir/Lamivudin Sandoz 600 mg/300 mg — Filmtabletten


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Belgium


 


Lupin (Europe) Ltd


Abacavir/Lamivudin Sandoz


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Belgium


 


Mylan bvba


Abacavir/Lamivudin Mylan


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Bulgaria


Sandoz d.d.


 


Abacavir/Lamivudin Sandoz


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Croatia


 


Lupin (Europe) Ltd


Abakavir/Lamivudin Sandoz 600 mg/300 mg filmom obložene tablete


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Cyprus


 


Lupin (Europe) Ltd


Abacavir/Lamivudine Sandoz


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Denmark


 


Lupin (Europe) Ltd


Abacavir/Lamivudine Sandoz


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Denmark


 


Mylan AB


Abacavir/Lamivudine Mylan


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Estonia


 


Lupin (Europe) Ltd


ABACAVIR/LAMIVUDINE SANDOZ


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Finland


 


Lupin (Europe) Ltd


Abacavir/Lamivudine Sandoz


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Finland


 


Mylan AB


Abacavir/Lamivudine Mylan


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




France


 


Venipharm


BAMIVENI


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




France


 


Venipharm


BAMIVUDINE


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




France


 


Venipharm


VIRAMUDINE


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Germany


 


Lupin (Europe) Ltd


Abacavir/Lamivudin 600 mg/300 mg Filmtabletten


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Germany


 


Lupin (Europe) Ltd


Abacavir/Lamivudine Hormosan 600 mg/300 mg Filmtabletten


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Germany


 


Lupin (Europe) Ltd


Abacavir/Lamivudin HEXAL 600 mg/300 mg Filmtabletten


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Germany


 


Lupin (Europe) Ltd


Abacavir/Lamivudin Aristo 600 mg/300 mg Filmtabletten


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Germany


 


Lupin (Europe) Ltd


Abacavir/Lamivudin Klinge 600 mg/300 mg Filmtabletten


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Ireland


 


Generics (UK) Limited


Abacavir/Lamivudine


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Ireland


 


Lupin (Europe) Ltd


Abacavir/Lamivudine Rowex


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Italy


 


Lupin (Europe) Ltd


ABACAVIR E LAMIVUDINA LUPIN


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Italy


 


Lupin (Europe) Ltd


ABACAVIR E LAMIVUDINA SANDOZ


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Italy


 


Lupin (Europe) Ltd


ABACAVIR E LAMIVUDINA MYLAN


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Italy


 


Lupin (Europe) Ltd


ABACAVIR E LAMIVUDINA ARISTO


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Lithuania


 


Lupin (Europe) Ltd


Abacavir/Lamivudine Sandoz 600 mg/300 mg plėvele dengtos tabletės


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Norway


 


Mylan AB


Abacavir/Lamivudin Mylan


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Poland


 


Lupin (Europe) Ltd


Abacavir+Lamivudine Sandoz


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Poland


 


Lupin (Europe) Ltd


Abacavir + Lamivudine Mylan


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Portugal


 


Lupin (Europe) Ltd


Abacavir + Lamivudina Lupin


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Portugal


 


Lupin (Europe) Ltd


Abacavir + Lamivudina Sandoz


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Portugal


 


Mylan, Lda.


Abacavir + Lamivudina Mylan


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Romania


 


Lupin (Europe) Ltd


Abacavir/lamivudină Sandoz 600 mg/300 mg, film-coated tablets


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Slovenia


 


Lupin (Europe) Ltd


Abakavir/lamivudin Sandoz 600 mg/300 mg filmsko obložene tablete


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Spain


 


Lupin (Europe) Ltd


Abacavir/Lamivudina Amneal 600 mg/300 mg comprimidos recubiertos con película EFG


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Spain


 


Lupin (Europe) Ltd


Abacavir/Lamivudina Aristo 600 mg/300 mg comprimidos recubiertos con película EFG


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Spain


 


Sandoz B.V.


Abacavir/Lamivudina Sandoz 600 mg/300 mg comprimimidos recubiertos con película EFG


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Spain


Mylan Pharmaceuticals, S.L.


 


Abacavir/Lamivudina Mylan 600 mg/300 mg comprimidos recubiertos con película EFG


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Sweden


 


Lupin (Europe) Ltd


Abacavir/Lamivudine Sandoz


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




Sweden


 


Mylan AB


Abacavir/Lamivudine Mylan


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




The Netherlands


 


Lupin (Europe) Ltd


Abacavir/Lamivudine Aristo


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




The Netherlands


 


Lupin (Europe) Ltd


Abacavir/Lamivudine Lupin


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




The Netherlands


 


Lupin (Europe) Ltd


Abacavir/Lamivudine Lupin


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




United Kingdom


 


Aristo Pharma GmbH


Abacavir/lamivudine 600 mg/300 mg film-coated tablets


abacavir/lamivudine


600 mg/300 mg


Tablet


Oral use




United Kingdom


 


Lupin (Europe) Ltd


Abacavir/lamivudine 600 mg/300 mg film-coated tablets


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




United Kingdom


 


Lupin (Europe) Ltd


Abacavir/lamivudine 600 mg/300 mg film-coated tablets


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use




United Kingdom


 


Generics (UK) Limited


Abacavir/lamivudine 600 mg/300 mg film-coated tablets


abacavir/lamivudine


600 mg/300 mg


Film-coated tablet


Oral use





Annex IB: 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


Active Substance


Strength


Pharmaceutical Form


Route of Administration




Belgium


 


Sandoz NV


Erlotinib Sandoz


erlotinib


25 mg


Film-coated tablet


Oral use




Belgium


 


Sandoz NV


Erlotinib Sandoz


erlotinib


100 mg


Film-coated tablet


Oral use




Belgium


 


Sandoz NV


Erlotinib Sandoz


erlotinib


150 mg


Film-coated tablet


Oral use




Belgium


 


Teva Pharma Belgium NV


Erlotinib Ratiopharm


erlotinib


25 mg


Film-coated tablet


Oral use




Belgium


 


Teva Pharma Belgium NV


Erlotinib Ratiopharm


erlotinib


100 mg


Film-coated tablet


Oral use




Belgium


 


Teva Pharma Belgium NV


Erlotinib Ratiopharm


erlotinib


150 mg


Film-coated tablet


Oral use




Belgium


 


Accord Healthcare Ltd


Saquinavir Accord


saquinavir


500 mg


Film-coated tablet


Oral use




Belgium


Teva Pharma Belgium NV


 


Atovaquone/Proguanil Teva


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




Belgium


Teva Pharma Belgium NV


 


Atovaquone/Proguanil Teva


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Belgium


Sandoz NV


 


Malaprotec


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




Belgium


Sandoz NV


 


Malaprotec


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Belgium


Sandoz NV


 


Saquinavir Sandoz


saquinavir


500 mg


Film-coated tablet


Oral use




Bulgaria


 


Teva B.V.


Erlotinib Teva Pharma B.V


erlotinib


100 mg


Film-coated tablet


Oral use




Bulgaria


 


Teva B.V.


Erlotinib Teva Pharma B.V


erlotinib


150 mg


Film-coated tablet


Oral use




Bulgaria


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


100 mg


Film-coated tablet


Oral use




Bulgaria


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


150 mg


Film-coated tablet


Oral use




Bulgaria


 


Accord Healthcare Limited


Saquinavir Accord


saquinavir


500 mg


Film-coated tablet


Oral use




Croatia


 


Sandoz B.V.


Erlotinib Sandoz 25 mg filmom obložene tablete


erlotinib


25 mg


Film-coated tablet


Oral use




Croatia


 


Sandoz B.V.


Erlotinib Sandoz 100 mg filmom obložene tablete


erlotinib


100 mg


Film-coated tablet


Oral use




Croatia


 


Sandoz B.V.


Erlotinib Sandoz 150 mg filmom obložene tablete


erlotinib


150 mg


Film-coated tablet


Oral use




Croatia


 


Teva B.V.


Erlotinib Pliva Hrvatska 25 mg filmom obložene tablete


erlotinib


25 mg


Film-coated tablet


Oral use




Croatia


 


Teva B.V.


Erlotinib Pliva Hrvatska 100 mg filmom obložene tablete


erlotinib


100 mg


Film-coated tablet


Oral use




Croatia


 


Teva B.V.


Erlotinib Pliva Hrvatska 150 mg filmom obložene tablete


erlotinib


150 mg


Film-coated tablet


Oral use




Croatia


 


Edicta Pharm d.o.o.


Edinib 25 mg filmom obložene tablete


erlotinib


25 mg


Film-coated tablet


Oral use




Croatia


 


Edicta Pharm d.o.o.


Edinib 100 mg filmom obložene tablete


erlotinib


100 mg


Film-coated tablet


Oral use




Croatia


 


Edicta Pharm d.o.o.


Edinib 150 mg filmom obložene tablete


erlotinib


150 mg


Film-coated tablet


Oral use




Cyprus


 


Sandoz B.V.


Erlotinib Hydrochloride Sandoz


erlotinib


150 mg


Film-coated tablet


Oral use




Cyprus


 


Accord Healthcare Ltd


Saquinavir Accord


saquinavir


500 mg


Film-coated tablet


Oral use




Czech Republic


 


Sandoz B.V.


Erlotinib Sandoz 25 mg


erlotinib


25 mg


Film-coated tablet


Oral use




Czech Republic


 


Sandoz B.V.


Erlotinib Sandoz 100 mg


erlotinib


100 mg


Film-coated tablet


Oral use




Czech Republic


 


Sandoz B.V.


Erlotinib Sandoz 150 mg


erlotinib


150 mg


Film-coated tablet


Oral use




Czech Republic


 


Vipharm S.A.


Erlotinib Vipharm 25 mg potahovane tablety


erlotinib


25 mg


Film-coated tablet


Oral use




Czech Republic


 


Vipharm S.A.


Erlotinib Vipharm 100 mg potahovane tablety


erlotinib


100 mg


Film-coated tablet


Oral use




Czech Republic


 


Vipharm S.A.


Erlotinib Vipharm 150 mg potahovane tablety


erlotinib


150 mg


Film-coated tablet


Oral use




Denmark


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


25 mg


Film-coated tablet


Oral use




Denmark


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


100 mg


Film-coated tablet


Oral use




Denmark


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


150 mg


Film-coated tablet


Oral use




Denmark


Orifarm Generics A/S


 


Atovaquone/Proguanil Orifarm


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Denmark


ratiopharm GmBH


 


Atovaquone/Proguanil ratiopharm


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Denmark


Sandoz A/S


 


Horisto


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




Denmark


Sandoz A/S


 


Horisto


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Denmark


Mylan AB


 


Eletriptan Mylan


eletriptan


40 mg


Film-coated tablet


Oral use




Estonia


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


25 mg


Film-coated tablet


Oral use




Estonia


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


100 mg


Film-coated tablet


Oral use




Estonia


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


150 mg


Film-coated tablet


Oral use




Estonia


 


Teva B.V.


ERLOTINIB TEVA GENERICS


erlotinib


100 mg


Film-coated tablet


Oral use




Estonia


 


Teva B.V.


ERLOTINIB TEVA GENERICS


erlotinib


150 mg


Film-coated tablet


Oral use




Finland


ratiopharm GmbH


 


Atovaquone/Proguanil ratiopharm


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Finland


Sandoz A/S


 


Rumbabor


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




Finland


Sandoz A/S


 


Rumbabor


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Finland


Mylan AB


 


Eletriptan Mylan


eletriptan


40 mg


Film-coated tablet


Oral use




France


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


25 mg


Film-coated tablet


Oral use




France


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


100 mg


Film-coated tablet


Oral use




France


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


150 mg


Film-coated tablet


Oral use




France


 


Teva B.V.


Erlotinib Teva Pharma


erlotinib


25 mg


Film-coated tablet


Oral use




France


 


Teva B.V.


Erlotinib Teva Pharma


erlotinib


100 mg


Film-coated tablet


Oral use




France


 


Teva B.V.


Erlotinib Teva Pharma


erlotinib


150 mg


Film-coated tablet


Oral use




France


 


Sandoz B.V.


SAQUINAVIR SANDOZ


saquinavir


500 mg


Film-coated tablet


Oral use




France


 


Medipha Sante


AMOXICILLINE MEDIPHA 1 g


amoxicillin


1 g


Orodispersible tablet


Oral use




France


Medipha Sante


 


Amoxicilline Authou


amoxicillin


1 g


Orodispersible tablet


Oral use




France


Sandoz


 


Atovaquone/Proguanil Sandoz ENFANTS


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




France


Sandoz


 


Atovaquone/Proguanil Sandoz


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




France


Teva Sante


 


Atovaquone/Proguanil Teva ENFANTS


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




France


Teva Sante


 


Atovaquone/Proguanil Teva


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




France


Venipharm


 


EBACHOI


ebastine


10 mg


Orodispersible tablet


Oral use




France


Venipharm


 


EBARREN


ebastine


10 mg


Film-coated tablet


Oral use




France


Biogaran


 


EBASTINE BIOGARAN


ebastine


10 mg


Film-coated tablet


Oral use




France


Biogaran


 


EBASTINE BIOGARAN


ebastine


10 mg


Orodispersible tablet


Oral use




France


Mylan SAS


 


EBASTINE MYLAN


ebastine


10 mg


Orodispersible tablet


Oral use




France


Mylan SAS


 


EBASTINE MYLAN


ebastine


10 mg


Film-coated tablet


Oral use




France


Sanofi Aventis France


 


EBASTINE ZENTIVA


ebastine


10 mg


Film-coated tablet


Oral use




France


Sanofi Aventis France


 


EBASTINE ZENTIVA


ebastine


10 mg


Orodispersible tablet


Oral use




France


Venipharm


 


EBONDE


ebastine


10 mg


Film-coated tablet


Oral use




France


Venipharm


 


EBONTAN


ebastine


10 mg


Orodispersible tablet


Oral use




France


Venipharm


 


EBOUDA


ebastine


10 mg


Film-coated tablet


Oral use




France


Mylan SAS


 


Eletriptan Mylan


eletriptan


20 mg


Film-coated tablet


Oral use




France


Mylan SAS


 


Eletriptan Mylan


eletriptan


40 mg


Film-coated tablet


Oral use




France


Medipha Sante


 


Tramadol/Paracétamol Nialex


tramadol/paracetamol


37,5  mg/325 mg


Film-coated tablet


Oral use




France


Zydus France


 


Tramadol/Paracétamol Zydus France


tramadol/paracetamol


37,5  mg/325 mg


Film-coated tablet


Oral use




Germany


 


Pharma Resources GmbH


Etoricoxib PhaRes 30 mg Filmtabletten


etoricoxib


30 mg


Film-coated tablet


Oral use




Germany


 


Pharma Resources GmbH


Etoricoxib PhaRes 60 mg Filmtabletten


etoricoxib


60 mg


Film-coated tablet


Oral use




Germany


 


Pharma Resources GmbH


Etoricoxib PhaRes 90 mg Filmtabletten


etoricoxib


90 mg


Film-coated tablet


Oral use




Germany


 


Pharma Resources GmbH


Etoricoxib PhaRes 120 mg Filmtabletten


etoricoxib


120 mg


Film-coated tablet


Oral use




Germany


 


Bristol Laboratories Ltd.


Celecoxib axcount 100 mg Hartkapseln


celecoxib


100 mg


Capsule, hard


Oral use




Germany


 


Bristol Laboratories Ltd.


Celecoxib axcount 200 mg Hartkapseln


celecoxib


200 mg


Capsule, hard


Oral use




Germany


 


Micro Labs GmbH


Amoxicillin Micro Labs 250 mg


amoxicillin


250 mg


Film-coated tablet


Oral use




Germany


 


Micro Labs GmbH


Amoxicillin Micro Labs 500 mg


amoxicillin


500 mg


Film-coated tablet


Oral use




Germany


 


Micro Labs GmbH


Amoxicillin Micro Labs 750 mg


amoxicillin


750 mg


Film-coated tablet


Oral use




Germany


 


Micro Labs GmbH


Amoxicillin Micro Labs 1 000  mg


amoxicillin


1 000  mg


Film-coated tablet


Oral use




Germany


 


Micro Labs GmbH


Rasagilin Micro Labs 1 mg Tabletten


rasagiline


1 mg


Film-coated tablet


Oral use




Germany


 


Lupin (Europe) Ltd


Duloxetin-Hormosan 60 mg magensaftresistente Hartkapseln


duloxetine


60 mg


Capsule, hard


Oral use




Germany


 


Lupin (Europe) Ltd


Duloxetin-Hormosan 40 mg magensaftresistente Hartkapseln


duloxetine


40 mg


Capsule, hard


Oral use




Germany


 


Lupin (Europe) Ltd


Duloxetin-Hormosan 30 mg magensaftresistente Hartkapseln


duloxetine


30 mg


Capsule, hard


Oral use




Germany


 


Lupin (Europe) Ltd


Duloxetin-Hormosan 20 mg magensaftresistente Hartkapseln


duloxetine


20 mg


Capsule, hard


Oral use




Germany


 


Micro Labs GmbH


Irbesartan/Hydrochlorothiazide Micro Labs 150 mg/12,5  mg Filmtabletten


irbesartan/hydrochlorothiazide


150 mg/12,5  mg


Film-coated tablet


Oral use




Germany


 


Micro Labs GmbH


Irbesartan/Hydrochlorothiazide Micro Labs 300 mg/12,5  mg Filmtabletten


irbesartan/hydrochlorothiazide


300 mg/12,5  mg


Film-coated tablet


Oral use




Germany


 


Micro Labs GmbH


Irbesartan/Hydrochlorothiazide Micro Labs 300 mg/25 mg Filmtabletten


irbesartan/hydrochlorothiazide


300 mg/25 mg


Film-coated tablet


Oral use




Germany


 


Sandoz B.V.


Erlotinib HEXAL 25 mg Filmtabletten


erlotinib


25 mg


Film-coated tablet


Oral use




Germany


 


Sandoz B.V.


Erlotinib HEXAL 100 mg Filmtabletten


erlotinib


100 mg


Film-coated tablet


Oral use




Germany


 


Sandoz B.V.


Erlotinib HEXAL 150 mg Filmtabletten


erlotinib


150 mg


Film-coated tablet


Oral use




Germany


 


Sandoz B.V.


Erlotinib — 1 A Pharma 25 mg Filmtabletten


erlotinib


25 mg


Film-coated tablet


Oral use




Germany


 


Sandoz B.V.


Erlotinib — 1 A Pharma 100 mg Filmtabletten


erlotinib


100 mg


Film-coated tablet


Oral use




Germany


 


Sandoz B.V.


Erlotinib — 1 A Pharma 150 mg Filmtabletten


erlotinib


150 mg


Film-coated tablet


Oral use




Germany


 


Teva B.V.


Erlotinib-ratiopharm 25 mg Filmtabletten


erlotinib


25 mg


Film-coated tablet


Oral use




Germany


 


Teva B.V.


Erlotinib-ratiopharm 100 mg Filmtabletten


erlotinib


100 mg


Film-coated tablet


Oral use




Germany


 


Teva B.V.


Erlotinib-ratiopharm 150 mg Filmtabletten


erlotinib


150 mg


Film-coated tablet


Oral use




Germany


 


Teva B.V.


Erlotinib-ratiopharm 25 mg Filmtabletten


erlotinib


25 mg


Film-coated tablet


Oral use




Germany


 


Teva B.V.


Erlotinib-ratiopharm 100 mg Filmtabletten


erlotinib


100 mg


Film-coated tablet


Oral use




Germany


 


Teva B.V.


Erlotinib-ratiopharm 150 mg Filmtabletten


erlotinib


150 mg


Film-coated tablet


Oral use




Germany


 


Teva B.V.


Erlotinib-ratiopharm 25 mg Filmtabletten


erlotinib


25 mg


Film-coated tablet


Oral use




Germany


 


Teva B.V.


Erlotinib-ratiopharm 100 mg Filmtabletten


erlotinib


100 mg


Film-coated tablet


Oral use




Germany


 


Teva B.V.


Erlotinib-ratiopharm 150 mg Filmtabletten


erlotinib


150 mg


Film-coated tablet


Oral use




Germany


Hexal Aktiengesellschaft


 


Saquinavir HEXAL 500 mg Filmtabletten


saquinavir


500 mg


Film-coated tablet


Oral use




Germany


ratiopharm GmbH


 


Atovaquon/Proguanilhydrochlorid-ratiopharm 62,5  mg/25 mg Filmtabletten


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




Germany


ratiopharm GmbH


 


Atovaquon/Proguanilhydrochlorid-ratiopharm 250 mg/100 mg Filmtabletten


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Germany


1A Pharma GmbH


 


Atovaquon/Proguanilhydrochlorid — 1 A Pharma 250 mg/100 mg Filmtabletten


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Germany


1A Pharma GmbH


 


Atovaquon/Proguanilhydrochlorid — 1 A Pharma 62,5  mg/25 mg Filmtabletten


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




Germany


Hexal Aktiengesellschaft


 


Malacomp HEXAL


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Germany


Hexal Aktiengesellschaft


 


Malacomp HEXAL junior


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




Germany


Hormosan Pharma Gesellschaft mit beschränkter Haftung


 


Pregabalin-Hormosan 25 mg Hartkapseln


pregabalin


25 mg


Capsule, hard


Oral use




Germany


Aristo Pharma GmbH


 


Eprosartan Aristo 600 mg Filmtabletten


eprosartan


600 mg


Film-coated tablet


Oral use




Germany


Glenmark Arzneimittel GmbH


 


Celecoxib Glenmark 200 mg Hartkapseln


celecoxib


200 mg


Capsule, hard


Oral use




Germany


Glenmark Arzneimittel GmbH


 


Celecoxib Glenmark 100 mg Hartkapseln


celecoxib


100 mg


Capsule, hard


Oral use




Greece


 


Genepharm SA


ERLOTINIB/GENEPHARM


erlotinib


25 mg


Film-coated tablet


Oral use




Greece


 


Genepharm SA


ERLOTINIB/GENEPHARM


erlotinib


100 mg


Film-coated tablet


Oral use




Greece


 


Genepharm SA


ERLOTINIB/GENEPHARM


erlotinib


150 mg


Film-coated tablet


Oral use




Hungary


 


Vipharm S.A.


ERLOTINIB VIPHARM 100 mg filmtabletta


erlotinib


100 mg


Film-coated tablet


Oral use




Hungary


 


Vipharm S.A.


ERLOTINIB VIPHARM 150 mg filmtabletta


erlotinib


150 mg


Film-coated tablet


Oral use




Hungary


 


Vipharm S.A.


ERLOTINIB VIPHARM 25 mg filmtabletta


erlotinib


25 mg


Film-coated tablet


Oral use




Hungary


 


Sandoz B.V.


ERLOTINIB Sandoz 25 mg filmtabletta


erlotinib


25 mg


Film-coated tablet


Oral use




Hungary


 


Sandoz B.V.


ERLOTINIB Sandoz 100 mg filmtabletta


erlotinib


100 mg


Film-coated tablet


Oral use




Hungary


 


Sandoz B.V.


ERLOTINIB Sandoz 150 mg filmtabletta


erlotinib


150 mg


Film-coated tablet


Oral use




Hungary


 


Lupin (Europe) Ltd


Pregabalin Merck 25 mg kemény kapszula


pregabalin


25 mg


Capsule, hard


Oral use




Iceland


Lyfis ehf.


 


Celecoxib LYFIS


celecoxib


100 mg


Capsule, hard


Oral use




Iceland


Lyfis ehf.


 


Celecoxib LYFIS


celecoxib


200 mg


Capsule, hard


Oral use




Ireland


 


Sandoz B.V.


Erlotinib Rowex


erlotinib


25 mg


Film-coated tablet


Oral use




Ireland


 


Sandoz B.V.


Erlotinib Rowex


erlotinib


100 mg


Film-coated tablet


Oral use




Ireland


 


Sandoz B.V.


Erlotinib Rowex


erlotinib


150 mg


Film-coated tablet


Oral use




Italy


 


Teva B.V.


ERLOTINIB TEVA


erlotinib


25 mg


Film-coated tablet


Oral use




Italy


 


Teva B.V.


ERLOTINIB TEVA


erlotinib


100 mg


Film-coated tablet


Oral use




Italy


 


Teva B.V.


ERLOTINIB TEVA


erlotinib


150 mg


Film-coated tablet


Oral use




Italy


 


Sandoz B.V.


ERLOTINIB SANDOZ


erlotinib


100 mg


Film-coated tablet


Oral use




Italy


 


Sandoz B.V.


ERLOTINIB SANDOZ


erlotinib


150 mg


Film-coated tablet


Oral use




Italy


Sandoz S.p.A.


 


ATOVAQUONE E PROGUANILE SANDOZ


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Italy


Sandoz S.p.A.


 


ATOVAQUONE E PROGUANILE SANDOZ


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




Italy


Sandoz S.p.A.


 


SAQUINAVIR SANDOZ


saquinavir


500 mg


Film-coated tablet


Oral use




Italy


Mylan S.p.A.


 


ELETRIPTAN MYLAN


eletriptan


20 mg


Film-coated tablet


Oral use




Italy


Mylan S.p.A.


 


ELETRIPTAN MYLAN


eletriptan


40 mg


Film-coated tablet


Oral use




Latvia


 


PharmaSwiss Česká republika s.r.o.


Erlotinib PharmaSwiss 25 mg film-coated tablets


erlotinib


25 mg


Film-coated tablet


Oral use




Latvia


 


PharmaSwiss Česká republika s.r.o.


Erlotinib PharmaSwiss 100 mg film-coated tablets


erlotinib


100 mg


Film-coated tablet


Oral use




Latvia


 


PharmaSwiss Česká republika s.r.o.


Erlotinib PharmaSwiss 150 mg film-coated tablets


erlotinib


150 mg


Film-coated tablet


Oral use




Latvia


 


Sandoz B.V.


Erlotinib Sandoz 25 mg film-coated tablets


erlotinib


25 mg


Film-coated tablet


Oral use




Latvia


 


Sandoz B.V.


Erlotinib Sandoz 100 mg film-coated tablets


erlotinib


100 mg


Film-coated tablet


Oral use




Latvia


 


Sandoz B.V.


Erlotinib Sandoz 150 mg film-coated tablets


erlotinib


150 mg


Film-coated tablet


Oral use




Latvia


 


Accord Healthcare Ltd


Saquinavir Accord 500 mg film-coated tablets


saquinavir


500 mg


Film-coated tablet


Oral use




Lithuania


 


PharmaSwiss Česká republika s.r.o.


Erlotinib PharmaSwiss


erlotinib


25 mg


Film-coated tablet


Oral use




Lithuania


 


PharmaSwiss Česká republika s.r.o.


Erlotinib PharmaSwiss


erlotinib


100 mg


Film-coated tablet


Oral use




Lithuania


 


PharmaSwiss Česká republika s.r.o.


Erlotinib PharmaSwiss


erlotinib


150 mg


Film-coated tablet


Oral use




Lithuania


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


25 mg


Film-coated tablet


Oral use




Lithuania


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


100 mg


Film-coated tablet


Oral use




Lithuania


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


150 mg


Film-coated tablet


Oral use




Lithuania


 


Teva B.V.


Erlotinib Teva Generics


erlotinib


150 mg


Film-coated tablet


Oral use




Lithuania


 


Accord Healthcare Ltd


Saquinavir Accord 500 mg plėvele dengtos tabletės


saquinavir


500 mg


Film-coated tablet


Oral use




Luxembourg


 


Sandoz S.A.


Saquinavir


saquinavir


500 mg


Film-coated tablet


Oral use




Luxembourg


 


Micro Labs GmbH


Irbesartan/Hydrochlorothiazide Micro Labs 150 mg/12,5  mg Filmtabletten


irbesartan/hydrochlorothiazide


150 mg/12,5  mg


Film-coated tablet


Oral use




Luxembourg


 


Micro Labs GmbH


Irbesartan/Hydrochlorothiazide Micro Labs 300 mg/12,5  mg Filmtabletten


irbesartan/hydrochlorothiazide


300 mg/12,5  mg


Film-coated tablet


Oral use




Luxembourg


 


Micro Labs GmbH


Irbesartan/Hydrochlorothiazide Micro Labs 300 mg/25 mg Filmtabletten


irbesartan/hydrochlorothiazide


300 mg/25 mg


Film-coated tablet


Oral use




Luxembourg


 


Teva B.V.


Erlotinib-ratiopharm 25 mg Filmtabletten


erlotinib


25 mg


Film-coated tablet


Oral use




Luxembourg


 


Teva B.V.


Erlotinib-ratiopharm 100 mg Filmtabletten


erlotinib


100 mg


Film-coated tablet


Oral use




Luxembourg


 


Teva B.V.


Erlotinib-ratiopharm 150 mg Filmtabletten


erlotinib


150 mg


Film-coated tablet


Oral use




Luxembourg


 


Teva B.V.


Erlotinib Ratiopharm


erlotinib


25 mg


Film-coated tablet


Oral use




Luxembourg


 


Teva B.V.


Erlotinib Ratiopharm


erlotinib


100 mg


Film-coated tablet


Oral use




Luxembourg


 


Teva B.V.


Erlotinib Ratiopharm


erlotinib


150 mg


Film-coated tablet


Oral use




Luxembourg


 


Micro Labs GmbH


Rasagilin Micro Labs 1 mg Tabletten


rasagiline


1 mg


Film-coated tablet


Oral use




Luxembourg


Sandoz S.A.


 


Malaprotec


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




Luxembourg


Sandoz S.A.


 


Malaprotec


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Luxembourg


ratiopharm GmbH


 


Atovaquon/Proguanilhydrochlorid-ratiopharm 62,5  mg/25 mg Filmtabletten


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




Luxembourg


ratiopharm GmbH


 


Atovaquon/Proguanilhydrochlorid-ratiopharm 250 mg/100 mg Filmtabletten


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Malta


1A Pharma GmbH


 


Reprapog


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




Malta


1A Pharma GmbH


 


Reprapog


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Norway


Mylan AB


 


Eletriptan Mylan


eletriptan


40 mg


Film-coated tablet


Oral use




Norway


Mylan AB


 


Eletriptan Mylan


eletriptan


20 mg


Film-coated tablet


Oral use




Norway


Orifarm Generics A/S


 


Atovaquone/Proguanil Orifarm


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Poland


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


25 mg


Film-coated tablet


Oral use




Poland


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


100 mg


Film-coated tablet


Oral use




Poland


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


150 mg


Film-coated tablet


Oral use




Poland


 


Vipharm S.A.


Erlotinib Vipharm


erlotinib


25 mg


Film-coated tablet


Oral use




Poland


 


Vipharm S.A.


Erlotinib Vipharm


erlotinib


100 mg


Film-coated tablet


Oral use




Poland


 


Vipharm S.A.


Erlotinib Vipharm


erlotinib


150 mg


Film-coated tablet


Oral use




Poland


Sandoz GmbH


 


Saquinavir Sandoz


saquinavir


500 mg


Film-coated tablet


Oral use




Portugal


 


Brown & Burk UK, Ltd.


Amoxicilina Brown


amoxicillin


250 mg


Film-coated tablet


Oral use




Portugal


 


Brown & Burk UK, Ltd.


Amoxicilina Brown


amoxicillin


500 mg


Film-coated tablet


Oral use




Portugal


 


Brown & Burk UK, Ltd.


Amoxicilina Brown


amoxicillin


750 mg


Film-coated tablet


Oral use




Portugal


 


Brown & Burk UK, Ltd.


Amoxicilina Brown


amoxicillin


1 000  mg


Film-coated tablet


Oral use




Portugal


 


Teva Pharma — Produtos Farmacêuticos, Lda.


Erlotinib Zidrium


erlotinib


25 mg


Film-coated tablet


Oral use




Portugal


 


Teva Pharma — Produtos Farmacêuticos, Lda.


Erlotinib Zidrium


erlotinib


100 mg


Film-coated tablet


Oral use




Portugal


 


Teva Pharma — Produtos Farmacêuticos, Lda.


Erlotinib Zidrium


erlotinib


150 mg


Film-coated tablet


Oral use




Portugal


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


25 mg


Film-coated tablet


Oral use




Portugal


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


100 mg


Film-coated tablet


Oral use




Portugal


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


150 mg


Film-coated tablet


Oral use




Portugal


 


Hetero Europe, S.L.


Celecoxib Hetero


Celecoxib


100 mg


Capsule, hard


Oral use




Portugal


 


Hetero Europe, S.L.


Celecoxib Hetero


Celecoxib


200 mg


Capsule, hard


Oral use




Portugal


 


Lupin (Europe) Ltd


Pregabalina Merck


Pregabalin


25 mg


Capsule, hard


Oral use




Portugal


Hetero Europe, S.L.


 


Eprosartan Hetero


eprosartan


600 mg


Film-coated tablet


Oral use




Portugal


Farmoz — Sociedade Técnico Medicinal, S.A.


 


Saquinavir Farmoz


saquinavir


500 mg


Film-coated tablet


Oral use




Portugal


Lupin (Europe) Ltd


 


Pregabalina Lupin


pregabalin


25 mg


Capsule, hard


Oral use




Romania


 


PharmaSwiss Česká republika s.r.o.


Erlotinib PharmaSwiss 25 mg film-coated tablets


erlotinib


25 mg


Film-coated tablet


Oral use




Romania


 


PharmaSwiss Česká republika s.r.o.


Erlotinib PharmaSwiss 100 mg film-coated tablets


erlotinib


100 mg


Film-coated tablet


Oral use




Romania


 


PharmaSwiss Česká republika s.r.o.


Erlotinib PharmaSwiss 150 mg film-coated tablets


erlotinib


150 mg


Film-coated tablet


Oral use




Romania


 


Teva B.V.


Erlotinib Teva Pharma 25 mg, film-coated tablets


erlotinib


25 mg


Film-coated tablet


Oral use




Romania


 


Teva B.V.


Erlotinib Teva Pharma 100 mg, film-coated tablets


erlotinib


100 mg


Film-coated tablet


Oral use




Romania


 


Teva B.V.


Erlotinib Teva Pharma 150 mg, film-coated tablets


erlotinib


150 mg


Film-coated tablet


Oral use




Romania


 


Sandoz B.V.


Erlotinib Sandoz 25 mg, film-coated tablets


erlotinib


25 mg


Film-coated tablet


Oral use




Romania


 


Sandoz B.V.


Erlotinib Sandoz 100 mg, film-coated tablets


erlotinib


100 mg


Film-coated tablet


Oral use




Romania


 


Sandoz B.V.


Erlotinib Sandoz 150 mg, film-coated tablets


erlotinib


150 mg


Film-coated tablet


Oral use




Slovakia


 


Sandoz B.V.


Erlotinib Sandoz 100 mg, 150 mg


erlotinib


100 mg


Film-coated tablet


Oral use




Slovakia


 


Sandoz B.V.


Erlotinib Sandoz 100 mg, 150 mg


erlotinib


150 mg


Film-coated tablet


Oral use




Slovakia


 


Vipharm S.A.


Erlotinib Vipharm 25 mg, 100 mg, 150 mg


erlotinib


25 mg


Film-coated tablet


Oral use




Slovakia


 


Vipharm S.A.


Erlotinib Vipharm 25 mg, 100 mg, 150 mg


erlotinib


100 mg


Film-coated tablet


Oral use




Slovakia


 


Vipharm S.A.


Erlotinib Vipharm 25 mg, 100 mg, 150 mg


erlotinib


150 mg


Film-coated tablet


Oral use




Slovakia


 


PharmaSwiss Česká republika s.r.o.


ERLOTIB 25 mg, 100 mg, 150 mg


erlotinib


25 mg


Film-coated tablet


Oral use




Slovakia


 


PharmaSwiss Česká republika s.r.o.


ERLOTIB 25 mg, 100 mg, 150 mg


erlotinib


100 mg


Film-coated tablet


Oral use




Slovakia


 


PharmaSwiss Česká republika s.r.o.


ERLOTIB 25 mg, 100 mg, 150 mg


erlotinib


150 mg


Film-coated tablet


Oral use




Slovenia


 


Sandoz B.V.


Erlotinib Sandoz 25 mg flmsko obložene tablete


erlotinib


25 mg


Film-coated tablet


Oral use




Slovenia


 


Sandoz B.V.


Erlotinib Sandoz 100 mg filmsko obložene tablete


erlotinib


100 mg


Film-coated tablet


Oral use




Slovenia


 


Sandoz B.V.


Erlotinib Sandoz 150 mg filmsko obložene tablete


erlotinib


150 mg


Film-coated tablet


Oral use




Spain


 


Sandoz B.V.


Erlotinib Sandoz 25 mg, 100 mg and 150 mg comprimidos recubiertos con película EFG


erlotinib


25 mg


Film-coated tablet


Oral use




Spain


 


Sandoz B.V.


Erlotinib Sandoz 25 mg, 100 mg and 150 mg comprimidos recubiertos con película EFG


erlotinib


100 mg


Film-coated tablet


Oral use




Spain


 


Sandoz B.V.


Erlotinib Sandoz 25 mg, 100 mg and 150 mg comprimidos recubiertos con película EFG


erlotinib


150 mg


Film-coated tablet


Oral use




Spain


 


Brill Pharma, S.L.


Celecoxib Brill Pharma 100 mg and 200 mg cápsulas duras


celecoxib


100 mg


Capsule, hard


Oral use




Spain


 


Brill Pharma, S.L.


Celecoxib Brill Pharma 100 mg and 200 mg cápsulas duras


celecoxib


200 mg


Capsule, hard


Oral use




Spain


 


Accord Healthcare Ltd


Saquinavir Accord 500 mg comprimidos recubiertos con película EFG


saquinavir


500 mg


Film-coated tablet


Oral use




Spain


Teva Pharma, S.L.U.


 


Atovacuona/Hidrocloruro de Proguanil Teva 250 mg/100 mg comprimidos recubiertos con película EFG


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Spain


Sandoz Farmaceutica, S.A.


 


Atovacuona/Hidrocloruro de Proguanil Sandoz 250 mg/100 mg comprimidos recubiertos con película EFG


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Spain


Pensa Pharma, S.A.U.


 


Eprosartan Pensa 600 mg comprimidos recubiertos con película EFG


eprosartan


600 mg


Film-coated tablet


Oral use




Spain


Industria Química Y Farmacéutica VIR, S.A.


 


Celecoxib VIR 200 mg cápsulas duras EFG


celecoxib


200 mg


Capsule, hard


Oral use




Sweden


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


25 mg


Film-coated tablet


Oral use




Sweden


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


100 mg


Film-coated tablet


Oral use




Sweden


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


150 mg


Film-coated tablet


Oral use




Sweden


Sandoz A/S


 


Horisto


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




Sweden


Sandoz A/S


 


Horisto


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Sweden


Mylan AB


 


Eletriptan Mylan


eletriptan


20 mg


Film-coated tablet


Oral use




Sweden


Mylan AB


 


Eletriptan Mylan


eletriptan


40 mg


Film-coated tablet


Oral use




Sweden


Orifarm Generics A/S


 


Atovaquone/Proguanil Orifarm


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




Sweden


Medical Valley Invest AB


 


Celecoxib Medical Valley


celecoxib


100 mg


Capsule, hard


Oral use




Sweden


Medical Valley Invest AB


 


Celecoxib Medical Valley


celecoxib


200 mg


Capsule, hard


Oral use




The Netherlands


 


PharmaSwiss Česká republika s.r.o.


ERLOTIB


erlotinib


25 mg


Film-coated tablet


Oral use




The Netherlands


 


PharmaSwiss Česká republika s.r.o.


ERLOTIB


erlotinib


100 mg


Film-coated tablet


Oral use




The Netherlands


 


PharmaSwiss Česká republika s.r.o.


ERLOTIB


erlotinib


150 mg


Film-coated tablet


Oral use




The Netherlands


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


25 mg


Film-coated tablet


Oral use




The Netherlands


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


100 mg


Film-coated tablet


Oral use




The Netherlands


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


150 mg


Film-coated tablet


Oral use




The Netherlands


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


25 mg


Film-coated tablet


Oral use




The Netherlands


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


100 mg


Film-coated tablet


Oral use




The Netherlands


 


Sandoz B.V.


Erlotinib Sandoz


erlotinib


150 mg


Film-coated tablet


Oral use




The Netherlands


 


Accord Healthcare Ltd


Saquinavir Accord


saquinavir


500 mg


Film-coated tablet


Oral use




The Netherlands


 


Teva B.V.


Erlotinib PCH


erlotinib


25 mg


Film-coated tablet


Oral use




The Netherlands


 


Teva B.V.


Erlotinib PCH


erlotinib


100 mg


Film-coated tablet


Oral use




The Netherlands


 


Teva B.V.


Erlotinib PCH


erlotinib


150 mg


Film-coated tablet


Oral use




The Netherlands


Teva Nederland B.V.


 


Atovaquon/Proguanil HCl Teva


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




The Netherlands


Teva Nederland B.V.


 


Atovaquon/Proguanil HCl Teva


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




The Netherlands


Sandoz B.V.


 


Atovaquon/Proguanil HCl Sandoz


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




The Netherlands


Sandoz B.V.


 


Atovaquon/Proguanil HCl Sandoz


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




The Netherlands


Sandoz B.V.


 


Atovaquon/Proguanil HCl Sandoz


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




The Netherlands


Sandoz B.V.


 


Atovaquon/Proguanil HCl Sandoz


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




The Netherlands


Sandoz B.V.


 


Saquinavir Sandoz


saquinavir


500 mg


Film-coated tablet


Oral use




The Netherlands


Sandoz B.V.


 


Saquinavir Sandoz


saquinavir


500 mg


Film-coated tablet


Oral use




The Netherlands


Hetero Europe, S.L.


 


Celecoxib Hetero


celecoxib


100 mg


Capsule, hard


Oral use




The Netherlands


Hetero Europe, S.L.


 


Celecoxib Hetero


celecoxib


200 mg


Capsule, hard


Oral use




United Kingdom


 


Brown & Burk UK, Ltd.


ROSUVASTATIN 5 MG FILM-COATED TABLETS


rosuvastatin


5 mg


Film-coated tablet


Oral use




United Kingdom


 


Brown & Burk UK, Ltd.


ROSUVASTATIN 10 MG FILM-COATED TABLETS


rosuvastatin


10 mg


Film-coated tablet


Oral use




United Kingdom


 


Brown & Burk UK, Ltd.


ROSUVASTATIN 20 MG FILM-COATED TABLETS


rosuvastatin


20 mg


Film-coated tablet


Oral use




United Kingdom


 


Brown & Burk UK, Ltd.


ROSUVASTATIN 40 MG FILM-COATED TABLETS


rosuvastatin


40 mg


Film-coated tablet


Oral use




United Kingdom


 


Brown & Burk UK, Ltd.


TRAMADOL/PARACETAMOL BROWN & BURK 37,5  MG/325 MG FILM-COATED TABLETS


tramadol/paracetamol


37,5  mg/325 mg


Film-coated tablet


Oral use




United Kingdom


 


Brown & Burk UK, Ltd.


Irbesartan/Hydrochlorothiazide Brown & Burk 150 mg/12,5  mg Film-coated tablets


irbesartan/hydrochlorothiazide


150 mg/12,5  mg


Film-coated tablet


Oral use




United Kingdom


 


Brown & Burk UK, Ltd.


Irbesartan/Hydrochlorothiazide Brown & Burk 300 mg/12,5  mg Film-coated tablets


irbesartan/hydrochlorothiazide


300 mg/12,5  mg


Film-coated tablet


Oral use




United Kingdom


 


Brown & Burk UK, Ltd.


Irbesartan/Hydrochlorothiazide Brown & Burk 300 mg/25 mg Film-coated tablets


irbesartan/hydrochlorothiazide


300 mg/25 mg


Film-coated tablet


Oral use




United Kingdom


 


Brown & Burk UK, Ltd.


Rasagiline Brown & Burk 1 mg Tablets


rasagiline


1 mg


Film-coated tablet


Oral use




United Kingdom


 


Lupin (Europe) Ltd


Duloxetine Lupin 20 mg GR capsules


duloxetine


20 mg


Capsule


Oral use




United Kingdom


 


Lupin (Europe) Ltd


Duloxetine Lupin 30 mg GR capsules


duloxetine


30 mg


Capsule


Oral use




United Kingdom


 


Lupin (Europe) Ltd


Duloxetine Lupin 40 mg GR capsules


duloxetine


40 mg


Capsule


Oral use




United Kingdom


 


Lupin (Europe) Ltd


Duloxetine Lupin 60 mg GR capsules


duloxetine


60 mg


Capsule


Oral use




United Kingdom


Teva UK Limited


 


MAFAMOZ 250 MG/100 MG FILM-COATED TABLETS


atovaquone/proguanil


250 mg/100 mg


Tablet


Oral use




United Kingdom


Teva UK Limited


 


MAFAMOZ 62,5  MG/25 MG FILM-COATED TABLETS


atovaquone/proguanil


62,5  mg/25 mg


Tablet


Oral use




United Kingdom


Sandoz Limited


 


REPRAPOG 62,5  MG/25 MG FILM-COATED TABLETS


atovaquone/proguanil


62,5  mg/25 mg


Film-coated tablet


Oral use




United Kingdom


Sandoz Limited


 


REPRAPOG 250 MG/100 MG FILM-COATED TABLETS


atovaquone/proguanil


250 mg/100 mg


Film-coated tablet


Oral use




United Kingdom


Brown & Burk UK Limited


 


AMOXICILLIN SUGAR FREE 3 G POWDER FOR ORAL SUSPENSION SACHETS


amoxicillin


3 443,35  mg


Powder for oral suspension


Oral use




United Kingdom


Hetero Europe, S.L.


 


EPROSARTAN 300 MG FILM-COATED TABLETS


eprosartan


300 mg


Film-coated tablet


Oral use




United Kingdom


Hetero Europe, S.L.


 


EPROSARTAN 400 MG FILM-COATED TABLETS


eprosartan


400 mg


Film-coated tablet


Oral use




United Kingdom


Hetero Europe, S.L.


 


EPROSARTAN 600 MG FILM-COATED TABLETS


eprosartan


600 mg


Film-coated tablet


Oral use




United Kingdom


Bristol Laboratories Limited


 


CELECOXIB CAPSULES, HARD 100 MG


celecoxib


100 mg


Capsule, hard


Oral use




United Kingdom


Bristol Laboratories Limited


 


CELECOXIB CAPSULES, HARD 200 MG


celecoxib


200 mg


Capsule, hard


Oral use




United Kingdom


Lupin (Europe) Ltd


 


Pregabalin Lupin 25 mg hard capsules


pregabalin


25 mg


Capsule, hard


Oral use