Therabel Gienne Pharma S.p.A.
Modifica secondaria di un'autorizzazione all'immissione in commercio di un medicinale per uso umano. Modifica apportata ai sensi del decreto legislativo 29 dicembre 2007, n. 274.
Titolare: Therabel GiEnne Pharma SpA - Via Lorenteggio 270/A Milano Specialita' medicinale: PRONTALGIN Confezione e numero di AIC:
50 mg capsule rigide - A.I.C. 033074030/M Modifica apportata ai sensi del Regolamento 1084/2003/CE Variazione Tipo IA n. 22.a. Presentazione certificato di idoneita' TSE Farmacopea Europea, nuovo o aggiornato, per l'eccipiente gelatina da produttore approvato o nuovo produttore (sostituzione o aggiunta).
1) Procedura MRP NL/H/0113/002/IA/032: presentazione nuovo certificato R1-CEP 2000-044-Rev 01 - Rousselot SAS 2) Procedura MRP NL/H/0113/002/IA/033: presentazione nuovo certificato R1-CEP 2000-058-Rev 01 - Rousselot SAS 3) Procedura MRP NL/H/0113/002/IA/034: sostituzione certificato R0-CEP 2003-028-Rev 01 con R0-CEP 2003-172-Rev 03 - Gelita Group 4) Procedura MRP NL/H/0113/002/IA/035: presentazione nuovo certificato R1-CEP 2000-050-Rev 00 - Gelita Group 5) Procedura MRP NL/H/0113/002/IA/036: aggiornamento certificato R0-CEP 2002-110-Rev 01 con R1-CEP 2002-110-Rev 00 - PB Gelatins 6) Procedura MRP NL/H/0113/002/IA/037: sostituzione certificato R0-CEP 2002-126-Rev 01 con R1-CEP 2000-140-Rev 01 - PB Gelatins 7) Procedura MRP NL/H/0113/002/IA/038: presentazione nuovo certificato R1-CEP 2001-211-Rev 00 - Sterling Gelatin 8) Procedura MRP NL/H/0113/002/IA/039: sostituzione certificato R0-CEP 2004-121-Rev 01 con R0-CEP 2004-247-Rev 00 - Nitta Gelatin Inc.
9) Procedura MRP NL/H/0113/002/IA/040: sostituzione certificato R0-CEP 2000-085-Rev 03 con R0-CEP 2004-320-Rev 00 - Nitta Gelatin Inc.
10) Procedura MRP NL/H/0113/002/IA/041: presentazione nuovo certificato R0-CEP 2005-217-Rev 00 - Nitta Gelatin Inc.
11) Procedura MRP NL/H/0113/002/IA/042: presentazione...
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