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
Titolare AIC: Dr. Willmar Schwabe GmbH & Co. KG, con sede in
Willmar-Schwabe-Str. 476227 Karlsruhe Germany
Specialita' Medicinale: NERVAXON 300 mg compresse rivestite
Confezioni e numero AIC:
45 compresse - AIC n. 033894041; 90 compresse - AIC n. 033894066;
15 compresse - AIC n. 033894015; 60 compresse - AIC n. 033894054; 100
compresse - AIC n. 033894078; 30 compresse - AIC n. 033894039; 20
compresse - AIC n. 033894027
Codice Pratica N1A/2011/820
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.I.d.1.b.1) Change to more restrictive storage
conditions of the active substance where no Ph. Eur. Certificate of
Suitability covering the retest period is part of the approved
dossier: Do not store above 25°C
Codice Pratica N1B/2011/641
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IB B.I.d.1.a)4. Change in the re-test period of the
active substance where no Ph. Eur. Certificate of Suitability
covering the retest period is part of the approved dossier, Extension
of the Re-test period from 6 months to 9 months
Codice Pratica N1A/2011/ 817
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA - B.III.2.c) Change to comply with Ph. Eur. -
Change in specifications from a national pharmacopoeia of a Member
State to the Ph. Eur: St. John's wort from DAC and additional
specifications to Ph. Eur. and additional specifications.
Codice Pratica N1A/2011/821
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.II.b.4 - Change in the batch size of the
finished product, a) Up to 10-fold compared to the currently approved
batch size: from 562 kg to 618.2 kg
Codice Pratica N1A/2011/824
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.III.2.c) Change to comply with Ph. Eur. - Change
in specifications from a national pharmacopoeia of a Member State to
the Ph. Eur: Pregelatinized maize starch from BP 1993 to Ph. Eur.
(current version)
Codice Pratica N1A/2011/825
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.II.c.1 Change in the specification parameters
and/or limits of an excipient; a) Tightening of in-process limits:
Antifoam emulsion, from in-house specification to USP (current
version)
Codice Pratica N1A/2011/816
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.I.a.1 Change in the manufacturer of a starting
material/reagent/intermediate used in the manufacturing process of
the active substance or change in the manufacturer of the active
substance, where no Ph. Eur. Certificate of Suitability is part of
the approved dossier; a) The proposed manufacturer is part of the
same pharmaceutical group as the currently approved manufacturer:
additional supplier of St. John's: APD GmbH
Codice Pratica N1A/2011/827
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.II.e.2 Change in the specification parameters
and/or limits of the immediate packaging of the finished product - a)
Tightening of specification limits: Container Closure System Blister
material: from PVC foil and aluminium foil or PVC/PVDC foil and
aluminium foil to PVC/PVDC foil and aluminium foil
Codice Pratica N1A/2011/823
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.II.c.1 Change in the specification parameters
and/or limits of an excipient; a) Tightening of in-process limit for
the excipient Iron oxide yellow E172
Codice Pratica N1A/2011/822
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.II.b.5 Change to in-process tests or limits
applied during the manufacture of the finished product, c) Deletion
of a non-significant in-process test - Control of Critical Steps
Ready for compressing mixture: Particle size extract: not specified
Codice Pratica N1A/2011/818
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA - B.I.a.2a) Minor change in the manufacturing
process of the active substance: addition of grinding the drug
substance bevor particle size analysis - St. John's wort dry extract
Codice Pratica N1A/2011/819
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.III.2 Change to comply with Ph. Eur. - a) Change
of specification(s) of a former non Pharmacopoeial substance to
comply with the Ph. Eur. - 1. Active substance: St. John's wort dry
extract from in-house specification to Ph. Eur. (current version) and
additional specifications
Codice Pratica N1A/2011/826
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.II.d.1 Change in the specification parameters
and/or limits of the finished product; c) Addition of a new
specification parameter to the specification with its corresponding
test method: Flavonoids greater than or equal 18.0 mg/c.t - Rutin
greater than or equal 4.5 mg / c.t.
I lotti gia' prodotti alla data della pubblicazione in Gazzetta
Ufficiale possono essere mantenuti in commercio fino alla data di
scadenza indicata in etichetta.
Head of International Regulatory & Scientific Affairs
Dott. U. Mathes
T11ADD8534
