# C_2018115EN.01000901.xml

| 28.3.2018 | EN | Official Journal of the European Union | C 115/9 |
| --- | --- | --- | --- |

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))

1

2

(2018/C 115/02)

| — | Suspension of a national marketing authorization |
| --- | --- |

—

Suspension of a national marketing authorization

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 |

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

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(1)  OJ L 311, 28.11.2001, p. 67.

1

(2)  OJ L 311, 28.11.2001, p. 1.

2

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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 |

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

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