Ordin nr. 1301/500/2008 din 11 iulie 2008 Partea a ii-a

Cod restricţie 1354: Acnee chistică severă care nu răspunde la alte tipuri de tratamente.

Acest medicament poate cauza defecte la naştere. Isotretinoin a fost incriminat pentru cauzarea frecventă a altor efecte toxice cu potenţial sever.

Se aplică tuturor denumirilor comerciale, formelor farmaceutice şi concentraţiilor corespunzătoare DCI-ului.
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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D10BA01 ISOTRETINOINUM CAPS. MOI 10 mg

ROACCUTANE 10 mg 10 mg ROCHE ROMANIA SRL

SOTRET 10 mg 10 mg RANBAXY U.K. LIMITED

D10BA01 ISOTRETINOINUM CAPS. MOI 20 mg

SOTRET 20 mg 20 mg RANBAXY U.K. LIMITED

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| 246 |G01AA02| NATAMYCINUM | |

|_______|_______|____________________________________________|_________________|
________________________________________________________________________________

DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

________________________________________________________________________________

G01AA02 NATAMYCINUM OVULE 100 mg

PIMAFUCIN(R) 100 mg ASTELLAS PHARMA EUROPE

B.V.
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| 247 |G01AA51| COMBINATII | |

|_______|_______|____________________________________________|_________________|

________________________________________________________________________________

DCI/DENUMIRE COMERCIALĂ FORMA FARM.

__________________________________________________

CONCENTRAŢIE FIRMA

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G01AA51 COMBINATII CREMA VAG. 10 g/400000 UI

MACMIROR COMPLEX 10 g/400000 UI POLICHEM SA
G01AA51 COMBINATII CAPS. MOI VAG. 500 mg/200000 UI

MACMIROR COMPLEX 500 mg/200000 UI POLICHEM SA

G01AA51 COMBINATII CAPS. MOI VAG.

POLYGYNAX LAB. INNOTECH INT.

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| 248 |G01AF12| FENTICONAZOLUM | |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G01AF12 FENTICONAZOLUM CAPS. MOI VAG. 600 mg

LOMEXIN 600 mg 600 mg RECORDATI SPA
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| 249 |G01AF15| BUTOCONAZOLUM | |

|_______|_______|____________________________________________|_________________|
________________________________________________________________________________

DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G01AF15 BUTOCONAZOLUM CREMA VAG.

GYNOFORT 2% GEDEON RICHTER LTD.
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| 251 |G01AX05| NIFURATELUM | |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G01AX05 NIFURATELUM DRAJ. 200 mg

MACMIROR 200 mg POLICHEM SA
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| 252 |G02CB03| CABERGOLINUM* | Protocol: G001C |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G02CB03 CABERGOLINUM COMPR. 0.5 mg

DOSTINEX 0.5 mg PFIZER EUROPE MA EEG
Prescriere limitată: Prevenirea apariţiei lactaţiei în lăuzie.

Cod restricţie 2659: Hiperprolactinemia patologică pentru care nu este indicată intervenţia chirurgicală.

Cod restricţie 2660: Hiperprolactinemia patologică pentru care a fost utilizat tratament chirurgical dar cu rezultate incomplete.
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| 253 |G03AC02| LYNESTRENOLUM* | |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

__________________________________________________

CONCENTRAŢIE FIRMA

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G03AC02 LYNESTRENOLUM COMPR. 0.5 mg

EXLUTON(R) 0.5 mg ORGANON NV
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| 254 |G03AC03| LEVONORGESTRELUM***# | Protocol: G005N |

|_______|_______|____________________________________________|_________________|
________________________________________________________________________________

DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03AC03 LEVONORGESTRELUM DISPOZITIV INTRAUTERIN 52 mg

MIRENA 20 µg/24 h 52 mg SCHERING OY (SCHERING AG)
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| 255 |G03CA04| ESTRIOLUM* | |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03CA04 ESTRIOLUM CREMA VAG. 0.1%

OVESTIN 0.1% ORGANON NV
G03CA04 ESTRIOLUM OVULE 0.5 mg

OVESTIN 0.5 mg ORGANON NV

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| 256 |G03CA09| PROMESTRIENUM* | |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03CA09 PROMESTRIENUM CAPS. MOI VAG. 10 mg

COLPOTROPHINE(R) 10 mg LAB. THERAMEX
G03CA09 PROMESTRIENUM CREMA VAG. 1%

COLPOTROPHINE(R) 1% LAB. THERAMEX

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| 257 |G03DA04| PROGESTERONUM* | |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03DA04 PROGESTERONUM CAPS. MOI 100 mg

UTROGESTAN(R) 100 mg 100 mg LAB. BESINS INTERNATIONAL
G03DA04 PROGESTERONUM GEL 1%

MASTOPROFEN 1% 1% ANTIBIOTICE SA

PROGESTOGEL 1% LAB. BESINS INTERNATIONAL
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| 258 |G03DB01| DYDROGESTERONUM* | |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03DB01 DYDROGESTERONUM COMPR. FILM. 10 mg

DUPHASTON(R) 10 mg SOLVAY PHARMACEUTICALS BV
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| 259 |G03DC03| LYNESTRENOLUM* | |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03DC03 LYNESTRENOLUM COMPR. 5 mg

ORGAMETRIL 5 mg ORGANON NV
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| 260 |G03DC05| TIBOLONUM** | Protocol: G007N |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03DC05 TIBOLONUM COMPR. 2,5 mg

LADYBON 2,5 mg ZENTIVA A.S.
G03DC05 TIBOLONUM COMPR. 2.5 mg

LIVIAL(R) 2,5 mg 2.5 mg ORGANON NV

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| 261 |G03FA01| COMBINATII** | Protocol: G002N |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03FA01 COMBINATII COMPR. FILM. 1 mg/0,5 mg

ACTIVELLE 1 mg/0,5 mg 1 mg/0,5 mg NOVO NORDISK A/S
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| 262 |G03FA14| COMBINATII** | Protocol: G002N |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

__________________________________________________

CONCENTRAŢIE FIRMA

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G03FA14 COMBINATII COMPR. FILM.

FEMOSTON(R) conti 1/5 SOLVAY PHARMACEUTICALS BV
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| 263 |G03FA15| ESTRADIOLUMVALERAT + DIENOGEST** | Protocol: G002N |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03FA15 ESTRADIOLUMVALERAT + DRAJ.

DIENOGEST

KLIMODIEN SCHERING AG

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| 264 |G03FA17| COMBINATII** | Protocol: G002N |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03FA17 COMBINATII COMPR. FILM.

ANGELIQ SCHERING AG
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| 265 |G03FB01| COMBINATII** | Protocol: G002N |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03FB01 COMBINATII DRAJ.

CYCLO PROGINOVA(R) SCHERING AG
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| 266 |G03FB05| COMBINATII** | Protocol: G002N |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03FB05 COMBINATII COMPR. FILM.

NOVOFEM NOVO NORDISK A/S
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| 267 |G03FB08| COMBINATII** | Protocol: G002N |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

__________________________________________________

CONCENTRAŢIE FIRMA

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G03FB08 COMBINATII COMPR. FILM.

FEMOSTON 2/10 SOLVAY PHARMACEUTICALS BV
G03FB08 COMBINATII COMPR. FILM.

FEMOSTON 2/10 SOLVAY PHARMACEUTICALS BV

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| 268 |G03GA05| FOLITROPINUM ALFA****# | Protocol: G003N |

|_______|_______|____________________________________________|_________________|
Prescriere limitată: Infertilitate anovulatorie.
NOTĂ:

Cu excepţia cazurilor de hipopituitarism sau amenoree primară, pacienta trebuie să fi fost tratată anterior cu citrat de clomifen şi/sau gonadorelin, iar tratamentul să fi rămas fără efect (sarcina nu a fost obţinută). Femeile care au urmat tratament pentru inducerea ovulaţiei cu alte clase de medicamente şi nu au obţinut o sarcină necesită evaluare laparoscopică pentru a exclude alte cauze care împiedică apariţia unei sarcini.
Se aplică tuturor denumirilor comerciale, formelor farmaceutice şi concentraţiilor corespunzătoare DCI-ului.
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03GA05 FOLITROPINUM ALFA PULB. + SOLV. PT. SOL. 150 UI

INJ.

GONAL-f 150 UI 150 UI SERONO EUROPE LTD.

G03GA05 FOLITROPINUM ALFA PULB. + SOLV. PT. SOL. 75 UI

INJ.

GONAL-f 75 UI 75 UI SERONO EUROPE LTD.
Prescriere limitată: Infertilitate anovulatorie
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| 269 |G03GA06| FOLLITROPINUM BETA****# | Protocol: G008N |

|_______|_______|____________________________________________|_________________|
Prescriere limitată: Infertilitate anovulatorie.
NOTĂ:

Cu excepţia cazurilor de hipopituitarism sau amenoree primară, pacienta trebuie să fi fost tratată anterior cu citrat de clomifen şi/sau gonadorelin, iar tratamentul să fi rămas fără efect (sarcina nu a fost obţinută). Femeile care au urmat tratament pentru inducerea ovulaţiei cu alte clase de medicamente şi nu au obţinut o sarcină necesită evaluare laparoscopică pentru a exclude alte cauze care împiedică apariţia unei sarcini.
Se aplică tuturor denumirilor comerciale, formelor farmaceutice şi concentraţiilor corespunzătoare DCI-ului.
________________________________________________________________________________

DCI/DENUMIRE COMERCIALĂ FORMA FARM.

__________________________________________________

CONCENTRAŢIE FIRMA

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G03GA06 FOLLITROPINUM BETA SOL. INJ. 100 UI/0.5 ml

PUREGON 100 UI/0,5 ml 100 UI/0.5 ml N.V. ORGANON
G03GA06 FOLLITROPINUM BETA SOL. INJ. 300 UI/0.36 ml

PUREGON 300 UI/0,36 ml 300 UI/0.36 ml N.V. ORGANON

G03GA06 FOLLITROPINUM BETA SOL. INJ. 50 UI/0.5 ml

PUREGON 50 UI/0,5 ml 50 UI/0.5 ml N.V. ORGANON

G03GA06 FOLLITROPINUM BETA SOL. INJ. 600 UI/0.72 ml

PUREGON 600 UI/0.72 ml 600 UI/0.72 ml N.V. ORGANON

G03GA06 FOLLITROPINUM BETA PULB + SOLV. PT. SOL. 100 UI/ml

INJ.

PUREGON 100 UI 100 UI/ml ORGANON NV
G03GA06 FOLLITROPINUM BETA PULB + SOLV. PT. SOL. 50 UI/ml

INJ

PUREGON 50 UI 50 UI/ml ORGANON NV
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| 271 |G03GB02| CLOMIFENUM | |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03GB02 CLOMIFENUM COMPR. 50 mg

CLOSTILBEGYT 50 mg EGIS PHARMACEUTICALS PLC

OVA-MIT 50 mg REMEDICA LTD.

Prescriere limitată: Infertilitate anovulatorie
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| 272 |G03XC01| RALOXIFENUM | |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G03XC01 RALOXIFENUM COMPR. FILM. 60 mg

EVISTA 60 mg 60 mg ELI LILLY NEDERLAND BV
Cod restricţie 3006: Monoterapie cu medicamente antiresorbtive pentru tratamentul şi profilaxia osteoporozei sexoidoprive la femei până la vârsta de 60 ani.
NOTĂ:

Agenţii antiresorbtivi utilizaţi în tratamentul osteoporozei instalate sunt: ALENDRONATE SODIUM, RISEDRONAT SODIUM, RALOXIFEN HYDROCHLORIDE, IBANDRONATE, ZOLENDRONATE ŞI STRONTIUM RANELATE (agent antiresorbtiv şi formator osos).
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| 273 |G04BD04| OXYBUTYNINUM | |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G04BD04 OXYBUTYNINUM COMPR. 5 mg

DRIPTANE(R) 5 mg 5 mg LAB. FOURNIER SA
Prescriere limitată: Hipereactivitate a detrusorului
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| 274 |G04BD07| TOLTERODINUM**# | Protocol: G010N |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G04BD07 TOLTERODINUM CAPS. ELIB. PREL. 4 mg

DETRUSITOL SR 4 mg 4 mg PFIZER EUROPE MA EEIG
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| 275 |G04BD08| SOLIFENACINUM SUCCINATE**# | Protocol: G009N |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G04BD08 SOLIFENACINUM COMPR. FILM. 10 mg

SUCCINATE

VESICARE 10 mg 10 mg ASTELLAS PHARMA EUROPE

B.V.

G04BD08 SOLIFENACINUM COMPR. FILM. 5 mg

SUCCINATE

VESICARE 5 mg 5 mg ASTELLAS PHARMA EUROPE

B.V.
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| 276 |G04BD09| TROSPIUM | |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

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CONCENTRAŢIE FIRMA

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G04BD09 TROSPIUM COMPR. FILM. 15 mg

INKONTAN 15 mg 15 mg PHARMAZEUTISCHE FABRIK

MONTAVIT GES. M.B.H.

G04BD09 TROSPIUM COMPR. FILM. 30 mg

INKONTAN 30 mg 30 mg PHARMAZEUTISCHE FABRIK

MONTAVIT GES. M.B.H.
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| 277 |G04CA01| ALFUZOSINUM | |

|_______|_______|____________________________________________|_________________|
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DCI/DENUMIRE COMERCIALĂ FORMA FARM.

__________________________________________________

CONCENTRAŢIE FIRMA

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G04CA01 ALFUZOSINUM COMPR. ELIB. PREL. 10 mg

ALFURAN MR 10 mg 10 mg TERAPIA S.A.

XATRAL SR 10 mg 10 mg SANOFI-SYNTHELABO FRANCE

G04CA01 ALFUZOSINUM COMPR. FILM. ELIB. 5 mg

PREL.

XATRAL(R) LP 5 mg 5 mg SANOFI-SYNTHELABO FRANCE
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| 278 |G04CA02| TAMSULOSINUM | |

|_______|_______|____________________________________________|_________________|
Prescriere limitată: Tratamentul hiperplaziei benigne de prostată.