ORDIN   Nr. 1182 din 20 septembrie 2004

pentru aprobarea Listei denumirilor comune internationale care necesita studii de bioechivalenta

ACT EMIS DE: MINISTERUL SANATATII

ACT PUBLICAT IN: MONITORUL OFICIAL  NR. 870 din 23 septembrie 2004

    Avand in vedere prevederile art. 10 alin. (9) din Ordonanta Guvernului nr. 125/1998 privind infiintarea, organizarea si functionarea Agentiei Nationale a Medicamentului, aprobata si modificata prin Legea nr. 594/2002, cu modificarile si completarile ulterioare, si ale Ordonantei de urgenta a Guvernului nr. 152/1999 privind produsele medicamentoase de uz uman, aprobata si modificata prin Legea nr. 336/2002, cu modificarile si completarile ulterioare,
    vazand Referatul de aprobare al Directiei generale farmaceutice, inspectia de farmacie si aparatura medicala nr. OB 10.650/2004,
    in temeiul Hotararii Guvernului nr. 743/2003 privind organizarea si functionarea Ministerului Sanatatii, cu modificarile ulterioare,

    ministrul sanatatii emite urmatorul ordin:

    Art. 1
    Se aproba Lista denumirilor comune internationale care necesita studii de bioechivalenta, conform anexei care face parte integranta din prezentul ordin.
    Art. 2
    (1) In vederea excluderii unei denumiri comune internationale din lista aprobata prin prezentul ordin, propunatorii vor depune la Agentia Nationala a Medicamentului o cerere insotita de documentatia de sustinere bazata pe criteriile de exceptare, prevazute in Ghidul privind investigarea biodisponibilitatii si bioechivalentei, adoptat prin Hotararea Consiliului stiintific al Agentiei Nationale a Medicamentului nr. 15 din 25 iunie 2004.
    (2) Propunerea de excludere va fi evaluata in prima sedinta a Consiliului stiintific al Agentiei Nationale a Medicamentului, planificata dupa data depunerii cererii, in care se va decide in legatura cu oportunitatea propunerii respective.
    Art. 3
    La data intrarii in vigoare a prezentului ordin se abroga orice dispozitie contrara.
    Art. 4
    Prezentul ordin se publica in Monitorul Oficial al Romaniei, Partea I.

                           Ministrul sanatatii,
                             Ovidiu Brinzan

    ANEXA 1*)

    *) Anexa este reprodusa in facsimil.

                                  LISTA
    denumirilor comune internationale care necesita studii de bioechivalenta

 ___________________________________________________________________________
| ACEBUTOLOLUM                         | ATENOLOLUM                         |
|______________________________________|____________________________________|
| ACEMETACINUM                         | ATORVASTATINUM                     |
|______________________________________|____________________________________|
| ACENOCOUMAROLUM                      | AZATHIOPRINUM                      |
|______________________________________|____________________________________|
| ACETAZOLAMIDUM                       | AZITHROMYCINUM                     |
|______________________________________|____________________________________|
| ACICLOVIRUM                          | BACLOFENUM                         |
|______________________________________|____________________________________|
| ACIDUM ALENDRONICUM                  | BAMBUTEROLUM                       |
|______________________________________|____________________________________|
| ACIDUM AMINOMETHYLBENZOICUM          | BENAZEPRILUM                       |
|______________________________________|____________________________________|
| ACIDUM CHENODEOXYCHOLICUM            | BENZATHINI BENZYLPENICILLINUM      |
|______________________________________|____________________________________|
| ACIDUM CLODRONICUM                   | BETAMETHASONUM                     |
|______________________________________|____________________________________|
| ACIDUM CROMOGLICICUM                 | BETAXOLOLUM                        |
|______________________________________|____________________________________|
| ACIDUM MEFENAMICUM                   | BENZAFIBRATUM                      |
|______________________________________|____________________________________|
| ACIDUM NALIDIXICUM                   | BICALUTAMIDUM                      |
|______________________________________|____________________________________|
| ACIDUM NIFLUMICUM                    | BIPERIDENUM                        |
|______________________________________|____________________________________|
| ACIDUM TIAPROFENICUM                 | BISOPROLOLUM                       |
|______________________________________|____________________________________|
| ACIDUM TILUDRONICUM                  | BRIVUDINUM                         |
|______________________________________|____________________________________|
| ACIDUM TRANEXANICUM                  | BROMAZEPAMUM                       |
|______________________________________|____________________________________|
| ACIDUM URSODEOXYCHOLICUM             | BROMOCRIPTINUM                     |
|______________________________________|____________________________________|
| ACIDUM VALPROICUM                    | BUFORMINUM                         |
|______________________________________|____________________________________|
| ACITRETINUM                          | BUSULFANUM                         |
|______________________________________|____________________________________|
| AJMALINUM                            | BUTAMIRATUM                        |
|______________________________________|____________________________________|
| ALFACALCIDOLUM                       | CABERGOLINUM                       |
|______________________________________|____________________________________|
| ALFUZOSINUM                          | CALCII FOLINAS                     |
|______________________________________|____________________________________|
| ALIMEMAZINUM                         | CALCITONINUM                       |
|______________________________________|____________________________________|
| ALLOPURINOLUM                        | CALCITRIOLUM                       |
|______________________________________|____________________________________|
| ALPRAZOLAMUM                         | CANDESARTANUM CILEXETIL            |
|______________________________________|____________________________________|
| AMANTADINUM                          | CAPTOPRILUM                        |
|______________________________________|____________________________________|
| AMFEPRAMONUM                         | CARBAMAZEPINUM                     |
|______________________________________|____________________________________|
| AMINOGLUTETHIMIDUM                   | CARBIMAZOLUM                       |
|______________________________________|____________________________________|
| AMINOPHYLLINUM                       | CARVEDILOLUM                       |
|______________________________________|____________________________________|
| AMIODARONUM                          | CEFACLORUM                         |
|______________________________________|____________________________________|
| AMISULPRIDUM                         | CEFADROXILUM                       |
|______________________________________|____________________________________|
| AMIPTRIPTYLINUM                      | CEFALEXINUM                        |
|______________________________________|____________________________________|
| AMLODIPINUM                          | CEFATRIZINUM                       |
|______________________________________|____________________________________|
| AMOXICILLINUM                        | CEFETAMETUM                        |
|______________________________________|____________________________________|
| AMOXICILLINUM + ACIDUM CLAVULANICUM  | CEFTIBUTENUM                       |
|______________________________________|____________________________________|
| AMPICILLINUM                         | CEFUROXIMUM                        |
|______________________________________|____________________________________|
| ANASTROZOLUM                         | CELIPROLOLUM                       |
|______________________________________|____________________________________|
| CETIRIZINUM                          | EFAVIRENZUM                        |
|______________________________________|____________________________________|
| CHINIDINI SULFAS                     | EMEPRONII BROMIDUM                 |
|______________________________________|____________________________________|
| CHLORAMBUCILUM                       | ENALAPRILUM                        |
|______________________________________|____________________________________|
| CHLORDIAZEPOXIDUM                    | EPIMESTROLUM                       |
|______________________________________|____________________________________|
| CHLOROQUINUM                         | EPROSARTANUM                       |
|______________________________________|____________________________________|
| CHLOROTRIANISENUM                    | ERYTHROMYCINUM                     |
|______________________________________|____________________________________|
| CHLORPROETHAZINUM                    | ESTRADIOLUM                        |
|______________________________________|____________________________________|
| CHLORPROMAZINUM                      | ESTRIOLUM                          |
|______________________________________|____________________________________|
| CICLOSPORINUM                        | ETHAMBUTOLUM                       |
|______________________________________|____________________________________|
| CILAZAPRILUM                         | ETHINYLESTRADIOLUM                 |
|______________________________________|____________________________________|
| CIMETIDINUM                          | ETHOSUXIMIDUM                      |
|______________________________________|____________________________________|
| CINOLAZEPAMUM                        | ETODOLACUM                         |
|______________________________________|____________________________________|
| CINOXACINUM                          | ETOPOSIDUM                         |
|______________________________________|____________________________________|
| CIPROFIBRATUM                        | ETRETINATUM                        |
|______________________________________|____________________________________|
| CIPROFLOXACINUM                      | FAMCICLOVIRUM                      |
|______________________________________|____________________________________|
| CLARITHROMYCINUM                     | FAMOTIDINUM                        |
|______________________________________|____________________________________|
| CLENBUTEROLUM                        | FELODIPINUM                        |
|______________________________________|____________________________________|
| CLINDAMYCINUM                        | FENOFIBRATUM                       |
|______________________________________|____________________________________|
| CLOBAZAMUM                           | FENOPROFENUM                       |
|______________________________________|____________________________________|
| CLOFEZONUM                           | FENOTEROLUM                        |
|______________________________________|____________________________________|
| CLOMIFENUM                           | FENSPIRIDUM                        |
|______________________________________|____________________________________|
| CLOMIPRAMINUM                        | FINASTERIDUM                       |
|______________________________________|____________________________________|
| CLONAZEPAMUM                         | FLECAINIDUM                        |
|______________________________________|____________________________________|
| CLOPIDOGRELUM                        | FLEROXACINUM                       |
|______________________________________|____________________________________|
| CLORAZEPAS DIKALII                   | FLUCONAZOLUM                       |
|______________________________________|____________________________________|
| CLOZAPINUM                           | FLUCYTOSINUM                       |
|______________________________________|____________________________________|
| CORTISONUM                           | FLUNITRAZEPAMUM                    |
|______________________________________|____________________________________|
| CYCLOPHOSPHAMIDUM                    | FLUOXETINUM                        |
|______________________________________|____________________________________|
| CYCLOSERINUM                         | FLUPHENAZINUM                      |
|______________________________________|____________________________________|
| CYPROTERONUM                         | FLUSPIRILENUM                      |
|______________________________________|____________________________________|
| DANAZOLUM                            | FLUTAMIDUM                         |
|______________________________________|____________________________________|
| DAPSONUM                             | FLUVASTATINUM                      |
|______________________________________|____________________________________|
| DETAJMIUM BITARTRATE                 | FLUVOXAMINUM                       |
|______________________________________|____________________________________|
| DEXAMETHASONUM                       | FOSFESTROLUM                       |
|______________________________________|____________________________________|
| DICLOFENACUM                         | FOSFOMYCINUM                       |
|______________________________________|____________________________________|
| DIDANOSINUM                          | FOSINOPRILUM                       |
|______________________________________|____________________________________|
| DIGOXINUM                            | FUROSEMIDUM                        |
|______________________________________|____________________________________|
| DIHYDROCODEINUM                      | GABAPENTINUM                       |
|______________________________________|____________________________________|
| DILTIAZEMUM                          | GALLOPAMILLUM                      |
|______________________________________|____________________________________|
| DIRITHROMICINUM                      | GANCICLOVIRUM                      |
|______________________________________|____________________________________|
| DISOPYRAMIDUM                        | GEMFIBROZILUM                      |
|______________________________________|____________________________________|
| DOMPERIDONUM                         | GLIBENCLAMIDUM                     |
|______________________________________|____________________________________|
| DOXAZOSINUM                          | GLICLAZIDUM                        |
|______________________________________|____________________________________|
| DOXYCYCLINUM                         | GLIPIZIDUM                         |
|______________________________________|____________________________________|
| DYDROGESTERONUM                      | GLIQUIDONUM                        |
|______________________________________|____________________________________|
| GRANISETRONUM                        | LOPERAMIDUM                        |
|______________________________________|____________________________________|
| GREPAFLOXACINUM                      | LORACARBEFUM                       |
|______________________________________|____________________________________|
| GRISEOFULVINUM                       | LORATADINUM                        |
|______________________________________|____________________________________|
| HALOPERIDOLUM                        | LORNOXICAMUM                       |
|______________________________________|____________________________________|
| HEXOPRENALINUM                       | LOVASTATINUM                       |
|______________________________________|____________________________________|
| HYDROCHLOROTHIAZIDUM                 | LOZARTANUM                         |
|______________________________________|____________________________________|
| HYDROCORTISONUM                      | LYNESTRENOLUM                      |
|______________________________________|____________________________________|
| HYDROXYCARBAMIDUM                    | MAPROTILINUM                       |
|______________________________________|____________________________________|
| HYDROXYCHLOROQUINUM                  | MEBENDAZOLUM                       |
|______________________________________|____________________________________|
| IBUPROFENUM                          | MEDAZEPAMUM                        |
|______________________________________|____________________________________|
| IDARUBICINUM                         | MEDROXYPROGESTERONUM               |
|______________________________________|____________________________________|
| IMIPRAMINUM                          | MEGESTROLUM                        |
|______________________________________|____________________________________|
| INDAPAMIDUM                          | MELOXICAMUM                        |
|______________________________________|____________________________________|
| INDINAVIRUM                          | MELPHALANUM                        |
|______________________________________|____________________________________|
| INDOMETACINUM                        | MERCAPTOPURINUM                    |
|______________________________________|____________________________________|
| IRBESARTANUM                         | MESTEROLONUM                       |
|______________________________________|____________________________________|
| ISOPRENALINUM                        | METAMIZOLUM NATRICUM               |
|______________________________________|____________________________________|
| ISOSORBIDI DINITRAS                  | METFORMINUM                        |
|______________________________________|____________________________________|
| ISOSORBIDI MONONITRAS                | METHOTREXATUM                      |
|______________________________________|____________________________________|
| ISOTRETINOINUM                       | METHOXALENUM                       |
|______________________________________|____________________________________|
| ISOXSUPRINUM                         | METHYLDOPUM                        |
|______________________________________|____________________________________|
| ISRADIPINUM                          | METHYLPREDNISOLONUM                |
|______________________________________|____________________________________|
| ITRACONAZOLUM                        | METHYLTHIOURACILUM                 |
|______________________________________|____________________________________|
| JOSAMYCINUM                          | METHYPRANOLOLUM                    |
|______________________________________|____________________________________|
| KEBUZONUM                            | METOCLOPRAMIDUM                    |
|______________________________________|____________________________________|
| KETOCONAZOLUM                        | METOPROLOLUM                       |
|______________________________________|____________________________________|
| KETOPROFENUM                         | METRONIDAZOLUM                     |
|______________________________________|____________________________________|
| KETOROLACUM TROMETHAMIN              | MEXILETINUM                        |
|______________________________________|____________________________________|
| LABETALOLUM                          | MIANSERINUM                        |
|______________________________________|____________________________________|
| LACIDIPINUM                          | MIDAZOLAMUM                        |
|______________________________________|____________________________________|
| LAMIVUDINUM                          | MIDODRINUM                         |
|______________________________________|____________________________________|
| LAMOTRIGINUM                         | MILNACIPRANUM                      |
|______________________________________|____________________________________|
| LANATOSIDUM C                        | MIRTAZAPINUM                       |
|______________________________________|____________________________________|
| LANSOPRAZOLUM                        | MOCLOBEMIDUM                       |
|______________________________________|____________________________________|
| LEUPRORELINUM                        | MONTELUKASTUM                      |
|______________________________________|____________________________________|
| LEVAMISOLUM                          | MORNIFLUMATUM                      |
|______________________________________|____________________________________|
| LEVODOPUM + CARBIDOPUM               | MORPHYNUM                          |
|______________________________________|____________________________________|
| LEVODOPUM + BENSERAZIDUM             | NABUMETONUM                        |
|______________________________________|____________________________________|
| LEVONORGESTRELUM                     | NAPROXENUM                         |
|______________________________________|____________________________________|
| LEVOTHYROXINUM                       | NARATRIPTANUM                      |
|______________________________________|____________________________________|
| LINCOMYCINUM                         | NEBIVOLOLUM                        |
|______________________________________|____________________________________|
| LISINOPRILUM                         | NELFINAVIRUM                       |
|______________________________________|____________________________________|
| LITHII CARBONAS                      | NEVIRAPINUM                        |
|______________________________________|____________________________________|
| LOMEFLOXACINUM                       | NICERGOLINUM                       |
|______________________________________|____________________________________|
| LONAZOLACUM                          | NICOTINUM                          |
|______________________________________|____________________________________|
| NIFEDIPINUM                          | PROCHLORPERAZINUM                  |
|______________________________________|____________________________________|
| NIMESULIDUM                          | PROGESTERONUM                      |
|______________________________________|____________________________________|
| NIMODIPINUM                          | PROPAFENONUM                       |
|______________________________________|____________________________________|
| NISOLDIPINUM                         | PROTIONAMIDUM                      |
|______________________________________|____________________________________|
| NITRAZEPAMUM                         | PYRIDOSTIGMINI BROMIDUM            |
|______________________________________|____________________________________|
| NITRENDIPINUM                        | PYRIMETHAMINUM                     |
|______________________________________|____________________________________|
| NITROFURANTOINUM                     | QUINAPRILUM                        |
|______________________________________|____________________________________|
| NITROGLYCERINUM                      | RALOXIFENUM                        |
|______________________________________|____________________________________|
| NIZATIDINUM                          | RAMIPRILUM                         |
|______________________________________|____________________________________|
| NOMEGESTROLUM                        | RANITIDINUM                        |
|______________________________________|____________________________________|
| NORETHISTERONUM                      | RANITIDINUM BISMUTH CITRATE        |
|______________________________________|____________________________________|
| NORFLOXACINUM                        | REPAGLINIDUM                       |
|______________________________________|____________________________________|
| NORTRIPTYLINUM                       | RIFABUTINUM                        |
|______________________________________|____________________________________|
| OFLOXACINUM                          | RIFAMPICINUM                       |
|______________________________________|____________________________________|
| OLANZAPINUM                          | RILMENIDINUM                       |
|______________________________________|____________________________________|
| OMEPRAZOLUM                          | RISPERIDONUM                       |
|______________________________________|____________________________________|
| ONDASETRONUM                         | RITORNAVIR                         |
|______________________________________|____________________________________|
| ORCIPRENALINUM                       | ROPINIROLUM                        |
|______________________________________|____________________________________|
| ORNIDAZOLUM                          | ROSOXACINUM                        |
|______________________________________|____________________________________|
| OXETORONUM                           | ROXITHROMYCINUM                    |
|______________________________________|____________________________________|
| OXPRENOLOLUM                         | SALBUTAMOLUM                       |
|______________________________________|____________________________________|
| PANTOPRAZOLUM                        | SAQUINAVIRUM                       |
|______________________________________|____________________________________|
| PAROXETINUM                          | SELEGILINUM                        |
|______________________________________|____________________________________|
| PEFLOXACINUM                         | SERTRALINUM                        |
|______________________________________|____________________________________|
| PENICILLAMINUM                       | SIMVASTATINUM                      |
|______________________________________|____________________________________|
| PENTAERITHRITYLI TETRANITRAS         | SOTALOLUM                          |
|______________________________________|____________________________________|
| PENTAZOCINUM                         | SPARFLOXACINUM                     |
|______________________________________|____________________________________|
| PENTOXIFYLLINUM                      | SPIRAMYCINUM                       |
|______________________________________|____________________________________|
| PENTOXYVERINUM                       | SPIRONOLACTONUM                    |
|______________________________________|____________________________________|
| PERGOLIDUM                           | STAVUDINUM                         |
|______________________________________|____________________________________|
| PERICIAZINUM                         | SUCCIMERUM                         |
|______________________________________|____________________________________|
| PERINDOPRILUM                        | SULFAMETHOXAZOLUM + TRIMETHOPRIMUM |
|______________________________________|____________________________________|
| PHENOXYMETHYLPENICILLINUM            | SULFAMETROLUM + TRIMETHOPRIMUM     |
|______________________________________|____________________________________|
| PIMOZIDUM                            | SULFASALAZINUM                     |
|______________________________________|____________________________________|
| PINDOLOLUM                           | SULINDACUM                         |
|______________________________________|____________________________________|
| PIRENZEPINUM                         | SULPIRIDUM                         |
|______________________________________|____________________________________|
| PIROXICAMUM                          | SULTAMICILLINUM                    |
|______________________________________|____________________________________|
| PRAMIPEXOLUM                         | SUMATRIPTANUM                      |
|______________________________________|____________________________________|
| PRAVASTATINUM                        | TALINOLOLUM                        |
|______________________________________|____________________________________|
| PRAZIQUANTELUM                       | TAMOXIFENUM                        |
|______________________________________|____________________________________|
| PRAZOSINUM                           | TAMSULOSINUM                       |
|______________________________________|____________________________________|
| PREDNISONUM                          | TELMISARTANUM                      |
|______________________________________|____________________________________|
| PROCARBAZINUM                        | TEMOZOLOMIDUM                      |
|______________________________________|____________________________________|
| TENONITROZOLUM                       | TRAMADOLUM                         |
|______________________________________|____________________________________|
| TENOXICAMUM                          | TRANDOLAPRILUM                     |
|______________________________________|____________________________________|
| TERAZOSINUM                          | TRETINOINUM                        |
|______________________________________|____________________________________|
| TERBUTALINUM                         | TRIAMCINOLONUM                     |
|______________________________________|____________________________________|
| TERFENADINUM                         | TRIFLOUPERAZINUM                   |
|______________________________________|____________________________________|
| TERTATOLOLUM                         | TRIHEXYPHENIDYLUM                  |
|______________________________________|____________________________________|
| TESTOSTERONUM                        | TRIMETAZIDINUM                     |
|______________________________________|____________________________________|
| TETRACOSACTIDUM                      | TRIMETHOPRIMUM + SULFAMERAZINUM    |
|______________________________________|____________________________________|
| TETRACYCLINUM                        | TRIMIPRAMINUM                      |
|______________________________________|____________________________________|
| TETRAZEPAMUM                         | TROPISETRONUM                      |
|______________________________________|____________________________________|
| THEOPHYLLINUM                        | TROVAFLOXACINUM                    |
|______________________________________|____________________________________|
| THIAMAZOLUM                          | VALACYCLOVIRUM                     |
|______________________________________|____________________________________|
| THIETHYLPERAZINUM                    | VALSARTANUM                        |
|______________________________________|____________________________________|
| THIOPROPERAZINUM                     | VASOPRESSINUM                      |
|______________________________________|____________________________________|
| TIABENDAZOLUM                        | VENLAFAXINUM                       |
|______________________________________|____________________________________|
| TIAGABINUM                           | VERAPAMILUM                        |
|______________________________________|____________________________________|
| TIANEPTINUM                          | VIGABATRINUM                       |
|______________________________________|____________________________________|
| TIAPRIDUM                            | VINCAMINUM                         |
|______________________________________|____________________________________|
| TICLOPIDINUM                         | VINPOCETINUM                       |
|______________________________________|____________________________________|
| TINIDAZOLUM                          | WARFARINUM                         |
|______________________________________|____________________________________|
| TIOGUANINUM                          | ZALCITABINUM                       |
|______________________________________|____________________________________|
| TOFISOPAMUM                          | ZIDOVUDINUM                        |
|______________________________________|____________________________________|
| TOLCAPONUM                           | ZOLPIDEMUM                         |
|______________________________________|____________________________________|
| TOPIRAMATUM                          | ZOPICLONUM                         |
|______________________________________|____________________________________|
| TOREMIFENUM                          | ZUCLOPENTHIXOLUM                   |
|______________________________________|____________________________________|