Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2018 to 28 February 2018 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2018-03-28
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, withdrawal from the market








C_2018115EN.01000901.xml










28.3.2018   


EN


Official Journal of the European Union


C 115/9





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2018 to 28 February 2018
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2018/C 115/02)






—



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




19.2.2018


Paracetamol, modified and prolonged release


paracetamol, modified and prolonged release


See Annex I


See Annex I


20.2.2018






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I
List of nationally authorised medicinal products










Member State
EU/EEA


Marketing authorisation holder


Invented name


INN + Strength


Pharmaceutical form


Route of administration




Belgium


GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.


PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE




Belgium


GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.


PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE




Belgium


GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.


PANADOL RETARD 8 STUNDEN, 665 MG TABLETTE MIT VERÄNDERTER WIRKSTOFFFREISETZUNG PARACETAMOL


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE




Belgium


GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.


PANADOL RETARD 8 STUNDEN, 665 MG TABLETTE MIT VERÄNDERTER WIRKSTOFFFREISETZUNG PARACETAMOL


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE




Belgium


GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.


PANADOL RETARD 8 UUR, 665 MG TABLET MET GEREGULEERDE AFGIFTE


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE




Belgium


GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.


PANADOL RETARD 8 UUR, 665 MG TABLET MET GEREGULEERDE AFGIFTE


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE




Bulgaria


KRKA, D.D., NOVO MESTO


ДОРЕТА SR 75 MG/650 MG ТАБЛЕТКИ С УДЪЛЖЕНО ОСВОБОЖДАВАНЕ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Czech Republic


KRKA, D.D., NOVO MESTO


DORETA PROLONG 75 MG/650 MG TABLETY S PRODLOUŽENÝM UVOLŇOVÁNÍM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Denmark


GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S


PANODIL RETARD, DEPOTTABLETTER


PARACETAMOL 500MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Denmark


GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S


PANODIL, TABLETTER MED MODIFICERET UDLØSNING


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE




Denmark


ACTAVIS GROUP HF.


PINEX RETARD


PARACETAMOL 500MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Estonia


KRKA, D.D., NOVO MESTO


DORETA, 75 MG/650 MG TOIMEAINET PROLONGEERITULT VABASTAVAD TABLETID


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Finland


GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S


PANADOL EXTEND 665 MG SÄÄDELLYSTI VAPAUTTAVA TABLETTI


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE




Finland


GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S


PANADOL EXTEND 665 MG TABLETT MED MODIFIERAD FRISÄTTNING PARACETAMOL


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE




Greece


GLAXOSMITHKLINE CONSUMER HEALTHCARE HELLAS SA


PANADOL EXTEND 665 MG ΔΙΣΚΙΑ ΕΛΕΓΧOΜΕΝΗΣ ΑΠΟΔEΣΜΕΥΣΗΣ


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE




Hungary


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG RETARD TABLETTA


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Hungary


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG RETARD TABLETTA


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Hungary


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG RETARD TABLETTA


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Hungary


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG RETARD TABLETTA


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Hungary


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG RETARD TABLETTA


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Hungary


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG RETARD TABLETTA


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Hungary


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG RETARD TABLETTA


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Hungary


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG RETARD TABLETTA


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Hungary


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG RETARD TABLETTA


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Hungary


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG RETARD TABLETTA


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Iceland


GEBRO PHARMA GMBH


DILIBAN RETARD 75 MG/650 MG FORÐATÖFLUR


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Iceland


GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S


PANODIL EXTEND


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE




Iceland


ACTAVIS HF.


PARATABS RETARD


PARACETAMOL 500MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Latvia


KRKA, D.D., NOVO MESTO


DORETA 75 MG/650 MG ILGSTOŠĀS DARBĪBAS TABLETES


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Lithuania


KRKA, D.D., NOVO MESTO


DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Lithuania


KRKA, D.D., NOVO MESTO


DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Lithuania


KRKA, D.D., NOVO MESTO


DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Lithuania


KRKA, D.D., NOVO MESTO


DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Lithuania


KRKA, D.D., NOVO MESTO


DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Lithuania


KRKA, D.D., NOVO MESTO


DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Lithuania


KRKA, D.D., NOVO MESTO


DORETA 75 MG/650 MG PAILGINTO ATPALAIDAVIMO TABLETĖS


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Luxembourg


GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.


PANADOL RETARD 8 HEURES, 665 MG COMPRIMÉ À LIBÉRATION MODIFIÉE


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE




Luxembourg


GLAXOSMITHKLINE CONSUMER HEALTHCARE S.A/N.V.


PANADOL RETARD 8 STUNDEN, 665 MG TABLETTE MIT VERÄNDERTER WIRKSTOFFFREISETZUNG PARACETAMOL


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE




Netherlands


GLAXOSMITHKLINE CONSUMER HEALTHCARE B.V


PANADOL EXTEND 665 MG, TABLETTEN MET GEREGULEERDE AFGIFTE


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE




Poland


KRKA, D.D., NOVO MESTO


DORETA SR, 75 MG + 650 MG, TABLETKI O PRZEDŁUŻONYM UWALNIANIU


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Portugal


JABA RECORDATI, S.A.


DILIBAN RETARD 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Portugal


JABA RECORDATI, S.A.


DILIBAN RETARD 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Portugal


GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA


PANADOL PROLONG, 665 MG, COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA


PARACETAMOL 665MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Portugal


KRKA, D.D., NOVO MESTO


TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA


PARACETAMOL 650MG TABLET, TRAMADOL 75MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Portugal


KRKA, D.D., NOVO MESTO


TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA


PARACETAMOL 650MG TABLET, TRAMADOL 75MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Portugal


KRKA, D.D., NOVO MESTO


TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA


PARACETAMOL 650MG TABLET, TRAMADOL 75MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Portugal


KRKA, D.D., NOVO MESTO


TRAMADOL + PARACETAMOL KRKA 75 MG + 650 MG COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


KRKA, D.D., NOVO MESTO


DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


KRKA, D.D., NOVO MESTO


DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


KRKA, D.D., NOVO MESTO


DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


KRKA, D.D., NOVO MESTO


DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


KRKA, D.D., NOVO MESTO


DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


KRKA, D.D., NOVO MESTO


DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


KRKA, D.D., NOVO MESTO


DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


KRKA, D.D., NOVO MESTO


DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


KRKA, D.D., NOVO MESTO


DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


KRKA, D.D., NOVO MESTO


DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


KRKA, D.D., NOVO MESTO


DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


KRKA, D.D., NOVO MESTO


DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


KRKA, D.D., NOVO MESTO


DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


KRKA, D.D., NOVO MESTO


DORETA EP 75 MG/650 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD


PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


PARACETAMOL 665MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD


PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


PARACETAMOL 665MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD


PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


PARACETAMOL 665MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Romania


GLAXOSMITHKLINE CONSUMER HEALTHCARE, GLAXOSMITHKLINE EXPORT LTD


PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ


PARACETAMOL 665MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovakia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETY S PREDLŽENÝM UVOLNOVANÍM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovenia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovenia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovenia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovenia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovenia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovenia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovenia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovenia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovenia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovenia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovenia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovenia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovenia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Slovenia


KRKA, D.D., NOVO MESTO


DORETA SR 75 MG/650 MG TABLETE S PODALJŠANIM SPROŠČANJEM


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Spain


LABORATORIOS GEBRO PHARMA, S.A.


DILIBAN RETARD 75 MG/650 MG COMPRIMIDOS DE LIBERACIÓN PROLONGADA


TRAMADOL HYDROCHLORIDE 75MG TABLET, PARACETAMOL 650MG TABLET


PROLONGED-RELEASE TABLET


ORAL USE




Sweden


GLAXOSMITHKLINE CONSUMER HEALTHCARE A/S


ALVEDON 665 MG TABLETT MED MODIFIERAD FRISÄTTNING


PARACETAMOL 665MG TABLET


MODIFIED-RELEASE TABLET


ORAL USE