Common SmPCs
Austria
Belgium
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Kazakhstan
Latvia
Lithuania
Luxembourg
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
Ukraine
United Kingdom
Arsenic trioxide medac - English texts
Bortezomib medac - common texts
Capecitabine medac - English texts
Carmustine medac 100 mg - English texts
Dacarbazine medac - common texts MR procedure
Gliolan 30 mg/ml (MAH: photonamic GmbH & Co. KG) - English texts
Grasustek (MAH: Juta Pharma GmbH) - English texts
| Download | Link |
|---|---|
| SmPC - English version |
Leflunomide medac - English texts
Methotrexate 25 mg/ml solution for injection - common texts
Methotrexate 100 mg/ml solution for injection - common texts
Oxaliplatin medac 5 mg/ml concentrate - common texts
| Download | Link |
|---|---|
| Common SmPC |
Temomedac - English texts
| Download | Link |
|---|---|
| SmPC - English version |
Vinorelbine medac 20 mg / 30 mg / 80 mg soft capsules - common texts
Dacarbazine medac 100 mg / 200 mg / 500 mg/ 10000 mg (AT)
Leflunomid medac (AT)
Spectrila 10.000 E Pulver für ein Konzentrat zur Herstellung einer Infusionslösung (AT)
Carmustine medac 100 mg (BE)
Dacarbazine medac 100 mg / 200 mg / 500 mg / 1000 mg (BE)
Gliolan 30 mg/ml (BE) - MAH: photonamic GmbH & Co. KG
Leflunomide medac (BE)
Levofolic 50 mg/ml oplossing voor injectie / infusie (BE)
Metoject 50 mg/ml oplossing voor injectie, voorgevulde injectiespuit / Metoject 50 mg/ml solution injectable, seringue préremplie (BE)
Spectrila (BE)
Leflunomid medac (HR)
Pemetreksed medac prašek za koncentrat za raztopino za infundiranje (HR)
Gliolan 30 mg/ml (CY) - MAH: photonamic GmbH & Co. KG
| Download | Link |
|---|---|
| SmPC |
Leflunomide medac (CZ)
Metoject 50 mg/ml injekční roztok v předplněné injekční stříkačce (CZ)
Metoject PEN 7.5/10/12.5/15/17.5/20/22.5/25/27.5/30 mg injekční roztok v předplněném peru (CZ)
Mitomycin medac 1 mg/ml prášek pro injekční/infuzní nebo intravezikální roztok (CZ)
Pamidronate medac 3 mg/ml, koncentrát pro infuzní roztok (CZ)
Temomedac 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg tvrdé tobolky (CZ)
Leflunomide medac (DK)
Mitomycin "medac", pulver og solvens til intravesikal opløsning 40 mg (DK)
Mitomycin "medac", pulver til injektions-/infusionsvæske, opløsning eller til intravesikal opløsning (DK)
Thiotepa "Medac", pulver til koncentrat til infusionsvæske, opløsning (DK)
Bendamustine medac (EE)
| Download | Link |
|---|---|
| SmPC |
Bleomycin medac (EE)
| Download | Link |
|---|---|
| SmPC |
Gliolan 30 mg/ml (EE) - MAH: photonamic GmbH & Co. KG
| Download | Link |
|---|---|
| SmPC |
Levofolinic acid medac (EE)
| Download | Link |
|---|---|
| SmPC |
Metex, 50mg/ml süstelahus süstlis (EE)
| Download | Link |
|---|---|
| SmPC |
Mitomycin medac, 1 mg/ml süste-, infusiooni- või intravesikaallahuse pulber (EE)
Pemetrexed medac 100 mg / 500 mg / 1000 mg infusioonilahuse kontsentraadi pulber (EE)
| Download | Link |
|---|---|
| SmPC |
BCG-medac (FI)
Gliolan 30 mg/ml (FI) - MAH: photonamic GmbH & Co. KG
Grasustek 6 mg injektioneste, esitäytetty ruisku (FI) - MAH: Juta Pharma GmbH
| Download | Link |
|---|---|
| SmPC |
Leflunomide medac (FI)
Metoject PEN 7.5/10/12.5/15/17.5/20/22.5/25/27.5/30 mg mg injektioneste, liuos, esitäytetty kynä (FI)
Mitomycin medac, 1 mg/ml, injektio-/infuusiokuiva-aine, liuosta varten / virtsarakkoon (FI)
Mitomycin medac, 40 mg, jauhe ja liuotin liuosta varten, virtsarakkoon (FI)
Pamifos (FI)
BCG-medac, Poudre et solvant pour suspension pour administration intravésicale (FR)
BENDAMUSTINE MEDAC 2,5 mg/mL, poudre pour solution à diluer pour perfusion (FR)
Dacarbazine medac 100 mg / 500 mg (FR)
Levofolinate de sodium medac 50 mg/mL, solution injectable/pour perfusion (FR)
Metoject solution injectable en seringue préremplie (FR)
| Download | Link |
|---|---|
| PIL Metoject 25 mg/0,5 ml solution injectable en seringue préremplie | |
| PIL Metoject 20 mg/0,4 ml solution injectable en seringue préremplie | |
| PIL Metoject 15 mg/0,3 ml solution injectable en seringue préremplie | |
| PIL Metoject 10 mg/0,2 ml solution injectable en seringue préremplie | |
| PIL 7,5 mg/0,15 ml solution injectable en seringue préremplie | |
| SmPC Metoject 25 mg/0,5 ml solution injectable en seringue préremplie | |
| SmPC Metoject 20 mg/0,4 ml solution injectable en seringue préremplie | |
| SmPC Metoject 15 mg/0,3 ml solution injectable en seringue préremplie | |
| SmPC Metoject 10 mg/0,2 ml solution injectable en seringue préremplie | |
| SmPC Metoject 7,5 mg/0,15 ml solution injectable en seringue préremplie |
METOJECT solution injectable en stylo prérempli (FR)
| Download | Link |
|---|---|
| PIL METOJECT 30 mg / 0,60 ml, solution injectable en stylo prérempli | |
| PIL METOJECT 27,5 mg / 0,55 ml, solution injectable en stylo prérempli | |
| PIL METOJECT 25 mg / 0,50 ml, solution injectable en stylo prérempli | |
| PIL METOJECT 22,5 mg / 0,45 ml, solution injectable en stylo prérempli | |
| PIL METOJECT 20 mg / 0,40 ml, solution injectable en stylo prérempli | |
| PIL METOJECT 17,5 mg / 0,35 ml, solution injectable en stylo prérempli | |
| PIL METOJECT 15 mg / 0,30 ml, solution injectable en stylo prérempli | |
| PIL METOJECT 12,5 mg / 0,25 ml, solution injectable en stylo prérempli | |
| PIL METOJECT 10 mg / 0,20 ml, solution injectable en stylo prérempli | |
| PIL METOJECT 7,5 mg / 0,15 ml, solution injectable en stylo prérempli | |
| SmPC METOJECT 30 mg / 0,60 ml, solution injectable en stylo prérempli | |
| SmPC METOJECT 27,5 mg / 0,55 ml, solution injectable en stylo prérempli | |
| SmPC METOJECT 25 mg / 0,50 ml, solution injectable en stylo prérempli | |
| SmPC METOJECT 22,5 mg / 0,45 ml, solution injectable en stylo prérempli | |
| SmPC METOJECT 20 mg / 0,40 ml, solution injectable en stylo prérempli | |
| SmPC METOJECT 17,5 mg / 0,35 ml, solution injectable en stylo prérempli | |
| SmPC METOJECT 15 mg / 0,30 ml, solution injectable en stylo prérempli | |
| SmPC METOJECT 12,5 mg / 0,25 ml, solution injectable en stylo prérempli | |
| SmPC METOJECT 10 mg / 0,20 ml, solution injectable en stylo prérempli | |
| SmPC METOJECT 7,5 mg / 0,15 ml, solution injectable en stylo prérempli |
THIOTEPA MEDAC 15 mg / 100 mg, poudre pour solution à diluer pour perfusion (FR)
VINORELBINE MEDAC 20 mg / 30 mg, capsule molle (FR)
Arsentrioxid medac 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung (DE)
BCG-medac Pulver und Lösungsmittel zur Herstellung einer Suspension zur intravesikalen Anwendung (DE)
Bendamustin medac 2,5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung (DE)
Bicalutamid medac (DE)
Bleomedac® 15 mg Pulver zur Herstellung einer Injektionslösung (DE)
Bortezomib medac (DE)
| Download | Link |
|---|---|
| PIL Bortezomib medac 3,5 mg Pulver zur Herstellung einer Injektionslösung | |
| PIL Bortezomib medac 2,5 mg Pulver zur Herstellung einer Injektionslösung | |
| Fachinformation Bortezomib medac 3,5 mg Pulver zur Herstellung einer Injektionslösung | |
| Fachinformation Bortezomib medac 2,5 mg Pulver zur Herstellung einer Injektionslösung |
Gliolan 30 mg/ml (DE) - Zulassungsinhaber: photonamic GmbH & Co. KG
Leflunomid medac (DE)
metex Tabletten (DE)
Methotrexat Injektionslösungen medac (DE)
| Download | Link |
|---|---|
| PIL Methotrexat 100 Injektionslösung medac | |
| PIL Methotrexat 25 Injektionslösung medac | |
| PIL Methotrexat 15 Injektionslösung medac | |
| Fachinformation Methotrexat 100 Injektionslösung medac | |
| Fachinformation Methotrexat 25 Injektionslösung medac | |
| Fachinformation Methotrexat 15 Injektionslösung medac |
Obnitix (DE)
| Download | Link |
|---|---|
| Produktinformation (Gebrauchs- und Fachinformation) |
Ovastat (DE)
Pamifos 3 mg/ml Konzentrat zur Herstellung einer Infusionslösung (DE)
Metoject 50 mg/ml ενέσιμο διάλυμα (Metoject 50 mg/ml, solution for injection) (GR)
Gliolan 30 mg/ml (HU) - MAH: photonamic GmbH & Co. KG
| Download | Link |
|---|---|
| SmPC |
Metoject 50 mg/ml oldatos injekció előretöltött fecskendőben (HU)
| Download | Link |
|---|---|
| SmPC |
Spectrila 10.000 E (HU)
| Download | Link |
|---|---|
| SmPC |
Thiotepa medac 15 mg / Thiotepa medac 100 mg (HU)
Metojectpen 7,5/ 10/12,5/15/17,5/20/22,5/25/27,5/30 mg stungulyf, lausn í áfylltum lyfjapenna (IS)
BCG-medac, powder and solvent for suspension for intravesical use (IE)
Gliolan 30 mg/ml (IE) - MAH: photonamic GmbH & Co. KG
| Download | Link |
|---|---|
| SmPC |
Metoject 7.5 mg / 10 mg / 15 mg / 20 mg / 25 mg solution for injection in pre-filled pen (IE)
| Download | Link |
|---|---|
| SmPC |
Mitomycin medac 40 mg powder and solvent for intravesical solution (IE)
Abiraterone medac 250 mg compresse / 500 mg compresse rivestite con film (IT)
BCG-medac, polvere e solvente per sospensione endovescicale (IT)
Bendamustina medac 2,5 mg/ml polvere per concentrato per soluzione per infusione (IT)
Bortezomib medac (IT)
Capecitabina medac 150 mg / 300 mg / 500 mg compresse rivestite con film (IT)
Carboplatino medac 10 mg/ml concentrato per soluzione per infusione (IT)
Mitomicina medac 1 mg/ml, polvere per soluzione iniettabile/ per infusione o per uso endovescicale (IT)
Triossido di arsenico medac 1 mg/mL concentrato per soluzione per infusione (IT)
Arsenic Trioxide medac, 1 mg/ml concentrate for solution for infusion, 10 ml (KZ)
Dacarbazine medac / ДАКАРБАЗИН МЕДАК (KZ)
Methotrexate medac 25 mg/ml, Solution for injection (KZ)
Methotrexate medac 100 mg/ml, Solution for Injection (KZ)
Metoject 50 mg/ml solution for subcutaneous administration (KZ) - combined text for syringe and Pen
Natriofolin medac, 50 mg/ml / Натриофолин медак 50 мг/мл (KZ)
Spectrila 10000 IU / Спектрила 10000 ХБ (KZ)
BCG-medac pulveris un šķīdinātājs intravezikāli lietojamas suspensijas pagatavošanai (LV)
Bendamustine medac 2,5 mg/ml pulveris infūziju šķīduma koncentrāta pagatavošanai (LV)
| Download | Link |
|---|---|
| SmPC |
Bleomycin medac 15000 SV pulveris injekciju šķīduma pagatavošanai (LV)
| Download | Link |
|---|---|
| SmPC |
Gliolan 30 mg/ml (LV) - MAH: photonamic GmbH & Co. KG
| Download | Link |
|---|---|
| SmPC |
Levofolic 50 mg/ml šķīdums injekcijai/ infūzijai (LV)
| Download | Link |
|---|---|
| SmPC |
Metex 50 mg/ml šķīdums injekcijām (LV)
| Download | Link |
|---|---|
| SmPC |
BCG-medac milteliai ir tirpiklis šlapimo pūslės suspensijai (LT)
Bendamustine medac 2,5 mg/ml milteliai infuzinio tirpalo koncentratui (LT)
| Download | Link |
|---|---|
| SmPC |
Bleomycin medac 15000 TV milteliai injekciniam tirpalui (LT)
| Download | Link |
|---|---|
| SmPC |
Gliolan 30 mg/ml (LT) - MAH: photonamic GmbH & Co. KG
| Download | Link |
|---|---|
| SmPC |
Levofolino rūgštis medac 50 mg/ml injekcinis ar infuzinis tirpalas (LT)
| Download | Link |
|---|---|
| SmPC |
Metex 50 mg/ml injekcinis tirpalas užpildytame švirkšte (LT)
| Download | Link |
|---|---|
| SmPC |
Mitomycin medac 1 mg/ml milteliai šlapimo pūslės tirpalui ar injekciniam tirpalui (LT)
Mitomycin medac 40 mg milteliai ir tirpiklis šlapimo pūslės tirpalui (LT)
Spectrila 10.000 V (LT)
| Download | Link |
|---|---|
| SmPC |
Gliolan 30 mg/ml (LU) - Zulassungsinhaber: photonamic GmbH & Co. KG
| Download | Link |
|---|---|
| Gliolan-SPC-LU-de |
BCG-medac, Poeder en oplosmiddel voor intravesicaal gebruik 2 x 108 CFU (NL)
Bleomedac, poeder voor oplossing voor injectie 15000 IU (Ph. Eur.) (NL)
Metoject PEN 7,5 mg=0,15 ml oplossing voor injectie in een voorgevulde pen (NL)
Mitomycine medac 40 mg, poeder en oplosmiddel voor oplossing voor intravesicaal gebruik (NL)
Pamipro 3 mg/ml, concentraat voor oplossing voor intraveneuze infusie (NL)
BCG-medac, pulver og væske til intravesikal bruk, suspensjon (NO)
Leflunomide medac (NO)
Mitomycin medac 1 mg/ml pulver til intravesikaloppløsning/injeksjons-/infusjonsvæske, oppløsning (NO)
Pemetrexed medac 100 mg / 500 mg / 1000 mg pulver til konsentrat til infusjonsvæske, oppløsning (NO)
Thiotepa medac 15 mg / 100 mg pulver til konsentrat til infusjonsvæske, oppløsning (NO)
BCG-medac, proszek i rozpuszczalnik do sporządzania zawiesiny do podawania do pęcherza moczowego (PL)
Bleomedac 15 000 IU/fiolkę proszek do sporządzania roztworu do wstrzykiwań (PL)
Bortezomib medac (PL)
Carbomedac, 10 mg/ml, koncentrat do sporządzania roztworu do infuzji (PL)
Detimedac (PL)
Leflunomide medac (PL)
Metex PEN, 7,5/10/12,5/15/17,5/20/22,5/25/27,5/30 mg, roztwór do wstrzykiwań we wstrzykiwaczu (PL)
Navirel, 10 mg/ml, koncentrat do sporządzania roztworu do infuzji (PL)
BCG-medac, Pó e solvente para suspensão para instilação intravesical (PT)
Bendamustina medac 2,5 mg/ml pó para concentrado para solução para perfusão (PT)
Leflunomida medac (PT)
Metex PEN 7,5/10/12,5/15/17,5/20/22,5/25/27,5/30 mg solução injetável em caneta pré-cheia (PT)
Vinorelbina Navirel 10 mg/ml concentrado para solução para perfusão (PT)
Gliolan 30 mg/ml (RO) - MAH: photonamic GmbH & Co. KG
| Download | Link |
|---|---|
| SmPC |
Spectrila (RO)
| Download | Link |
|---|---|
| SmPC |
BCG-medac, prášok a vehikulum na intravezikálnu suspenziu (SK)
Leflunomide medac (SK)
Metoject PEN 7,5/10/12,5/15/17,5/20/22,5/25/27,5/30 mg injekčný roztok naplnený v injekčnom pere (SK)
Mitomycin medac 1 mg/ml prášok na injekčný/infúzny roztok alebo na intravezikálne použitie (SK)
Mitomycin medac 40 mg prášok a rozpúšťadlo na intravezikálny roztok (SK)
Temomedac 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg tvrdé kapsuly (SK)
Metoject 50 mg/ml raztopina za injiciranje v napolnjeni injekcijski brizgi (SI)
Metoject PEN 50 mg/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku (SI)
Mitomicin medac 1 mg/ml prašek za raztopino za injiciranje/infundiranje ali za intravezikalno raztopino (SI)
Mitomicin medac 40 mg prašek in vehikel za intravezikalno raztopino (SI)
Pemetreksed medac prašek za koncentrat za raztopino za infundiranje (SI)
Dacarbazina medac 500 (1000) mg polvo para solución para perfusión (ES)
Leflunomida medac 10 mg/ 15 mg/ 20 mg comprimidos recubiertos con película EFG (ES)
Metoject PEN 7,5/10/12,5/15/17,5/20/22,5/25/27,5/30 mg solución inyectable en pluma precargada (ES)
Mitomicina medac 2 mg (10 mg; 20 mg; 40 mg) polvo para solución intravesical y para solución inyectable EFG (ES)
Vejicur, polvo y disolvente para suspensión para uso intravesical (ES)
BCG-medac, pulver och vätska till intravesikal användning, suspension (SE)
Bendamustine medac 2,5 mg/ml pulver till koncentrat till infusionsvätska, lösning (SE)
Dacarbazine medac 100 mg, Pulver till injektions- och infusionsvätska, lösning (SE)
Leflunomide medac (SE)
Metoject 50 mg/ml injektionsvätska, lösning, förfylld spruta (SE)
Metojectpen injektionsvätska, lösning, i förfylld injektionspenna (SE)
Metotab 2,5mg; 7,5mg; 10mg tablet (SE)
Mitomycin medac, 40 mg, pulver och vätska till intravesikal lösning (SE)
Natriumlevofolinat medac 50 mg/ml injektions-/infusionsvätska, lösning (SE)
Pamifos 3 mg/ml, koncentrat till infusionsvätska, lösning (SE)
Pemetrexed medac 100 mg / 500 mg / 1000 mg pulver till koncentrat till infusionsvätska, lösning (SE)
Temomedac 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg hårda kapslar (SE)
Carboplatin medac / КАРБОПЛАТИН МЕДАК (UA)
| Download | Link |
|---|---|
| Instruction for medical use (SmPC) |
Dacarbazine medac / ДАКАРБАЗИН МЕДАК (UA)
| Download | Link |
|---|---|
| Instruction for medical use (SmPC) |
Epirubicine medac / ЕПІРУБІЦИН МЕДАК (UA)
| Download | Link |
|---|---|
| Instruction for medical use (SmPC) |
Fluorouracil medac / ФЛЮОРОУРАЦИЛ МЕДАК (UA)
| Download | Link |
|---|---|
| Instruction for medical use (SmPC) |
Hydroxyurea medac / ГІДРОКСИСЕЧОВИНА МЕДАК (UA)
| Download | Link |
|---|---|
| Instruction for medical use (SmPC) |
Irinotecan medac / ІРИНОТЕКАН МЕДАК (UA)
| Download | Link |
|---|---|
| Instruction for medical use (SmPC) |
LEFLUTAB / ЛЕФЛЮТАБ (UA)
Levofolic / ЛЕВОФОЛІК, pозчин для ін’єкцій або інфузій, 50 мr/мл (UA)
| Download | Link |
|---|---|
| Instruction for medical use (SmPC) |
Lomustine medac / ЛОМУСТИН МЕДАК (UA)
| Download | Link |
|---|---|
| Instruction for medical use (SmPC) |
METOJECT® / МЕТОДЖЕКТ®, Розчин для ін'єкцій, 50 мг/мл (UA)
| Download | Link |
|---|---|
| Instruction for medical use (SmPC) |
Metotab / МЕТОТАБ (UA)
NAVIREL / НАВІРЕЛ (UA)
| Download | Link |
|---|---|
| Instruction for medical use (SmPC) |
Pamifos / ПАМІФОС (UA)
SPECTRILA / СПЕКТРІЛА, Порошок для концентрату для розчину для інфузій, ло 10 000 ОД (UA)
| Download | Link |
|---|---|
| Instruction for medical use (SmPC) |
TEMOMEDAC / ТЕМОМЕДАК капсули 5 мг (UA)
| Download | Link |
|---|---|
| Instruction for medical use (SmPC) |
Trecondi (UA)
| Download | Link |
|---|---|
| Instruction for medical use (SmPC) |
Dacarbazine medac 100 mg / 200 mg / 500 mg / 1000 mg (UK)
Fluorouracil (UK)
Irinotecan Hydrochloride medac 20 mg/ml, concentrate for solution for infusion (UK)
Leflunomide medac 15 mg film-coated tablets (UK)
Metoject PEN 7.5/10/12.5/15/17.5/20/22.5/25/27.5/30 mg solution for injection in pre-filled pen (UK)
Mitomycin medac, 40 mg, Powder and solvent for intravesical solution (UK)
Trecondi 1 g / 5 g powder for solution for infusion (UK)