ratiopharm Gmbh Rappresentante in Italia: ratiopharm Italia - S.r.l.
Modifica secondaria di un'autorizzazione all'immissione in commercio di una specialita' medicinale per uso umano. (Modifica apportata ai sensi del decreto legislativo 29 dicembre 2007, n. 274). Modifica apportata ai sensi del regolamento n. 1084/2003/CE.
Specialita' medicinale: ATENOLOLO CLORTALIDONE RATIOPHARM.
Confezioni e numeri di A.I.C.:
'50 mg/12,5 mg compresse' 28 compresse - A.I.C. n. 033054014;
'100 mg/25 mg compresse' 28 compresse - A.I.C. n. 033054026.
Variazione tipo IA n. 15a Presentazione di un certificato d'idoneita' della Farmacopea europea aggiornato relativo al principio attivo Clortalidone da parte del produttore approvato Archimica S.r.l.
- R1-CEP 2001-020-Rev 02.
Specialita' medicinale: DILTIAZEM RATIOPHARM.
Confezioni e numeri di A.I.C.:
'120 mg capsule a rilascio modificato' 28 capsule - A.I.C. n.
033175023;
'180 mg capsule a rilascio modificato' 28 capsule - A.I.C. n.
033175035;
'240 mg capsule a rilascio modificato' 28 capsule - A.I.C. n.
033175047.
Variazione tipo IA n. 22a Presentazione del Certificate of Suitability TSE della Farmacopea europea relativo alla gelatina da parte di un nuovo produttore Sterling Gelatin - R1-CEP 2001-211-Rev 00. Variazione tipo IA n. 22a Presentazione del Certificate of Suitability TSE della Farmacopea europea relativo alla gelatina da parte di un produttore attualmente autorizzato (sostituzione) PB Gelatins - R1-CEP 2002-110-Rev 00. Variazione tipo IA n. 22a Presentazione del Certificate of Suitability TSE della Farmacopea europea relativo alla gelatina da parte di un produttore attualmente autorizzato (sostituzione) Gelita Group - R1-CEP 2003-172-Rev 00.
Specialita' medicinale: TICLOPIDINA RATIOPHARM.
Confezione e numero di A.I.C.:
250 mg 30 compresse -...
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