Parte Seconda n. 60 del 22-5-2012
Altri annunzi
Specialita' medicinali, presidi sanitari e medico chirurgici
BRUSCHETTINI S.R.L.
Sede Legale: Via Isonzo n. 6 - 16147 Genova Codice fiscale n. 00265870105
(GU Parte Seconda n.60 del 22-5-2012)

Modifica secondaria di un'autorizzazione all'immissione in commercio
di specialità medicinale per uso umano. Modifica apportata ai sensi
del Decreto Legislativo 29 dicembre 2007, n. 274.


Specialità medicinale:BRIMOFTAL. Confezioni e numeri AIC: "2 mg/ml
collirio, soluzione" 1 flacone da 5 ml - AIC n. 038714010/M; "2 mg/ml
collirio, soluzione" 3 flaconi da 5 ml - AIC n. 038714022/M; "2 mg/ml
collirio, soluzione" 6 flaconi da 5 ml - AIC n. 038714034/M; "2 mg/ml
collirio, soluzione" 1 flacone da 10 ml - AIC n. 038714046/M; "2
mg/ml collirio, soluzione" 3 flaconi da 10 ml - AIC n. 038714059/M.
Modifiche apportate ai sensi del Regolamento (CE) 1234/2008:
Grouping of Variation Tipo IB e IA
MPR DK/H/1384/001/IB/007/G - Codice Pratica C1B/2011/2081
Variazione Tipo IB n.B.I.a.2.e: Changes in the manufacturing
process of the active substance. Minor change to the restricted part
of an Active Substance Master File (lowering of quantity of solvents
and water).
Variazione Tipo IB n. B.I.a.3.a: Change in batch size of active
substance or intermediate up to 10-fold increase compared to the
currently approved batch size Increase in batch size to 23 kg
N. 8 Variazioni Tipo IA n. B.I.b.1.c: Change in the specification
parameters and/or limits of an active substance, starting
material/intermediate/reagent used in the manufacturing process of
the active substance: Addition of a new specification parameter to
the specification with its corresponding test method: addition of
identification test for the starting material tartaric acid; addition
of calcium test for the starting material tartaric acid;
addition of chlorides test for the starting material tartaric acid;
addition of identification test for the starting material
ethylendiamine; addition of purity test for the starting material
ethylendiamine; addition of identification test for the starting
material xylene; addition of assay test for the starting material
xylene; Inclusion of identification test for tartrate in the active
substance.
MPR DK/H/1384/001/IB/008/G - Codice Pratica C1B/2011/2082
Variazione Tipo IA n.B.I.a.3.a: Change in batch size of active
substance or intermediate up to 10-fold increase compared to the
currently approved batch size.
Variazione Tipo IA n.B.I.c.1.a: Change in immediate packaging of
the active substance. Qualitative and/or quantitative composition.
Variazione Tipo IB n.B.I.b.z: Change in control of the active
substance.
Addition of impurity test.
MPR DK/H/1384/001/IB/009/G - Codice Pratica C1B/2011/2080
Variazione Tipo IA n. B.I.a.3.a: Change in batch size of active
substance or intermediate up to 10-fold increase compared to the
currently approved batch size.
Variazione Tipo IA n.B.I.b.1.c: Change in the specification
parameters and/or limits of an active substance, starting
material/intermediate/reagent used in the manufacturing process of
the active substance Addition of a new specification parameter to the
specification with its corresponding test method: Identification of
tartrate.
Variazione Tipo IB n. B.I.b.z: Change in control of the active
substance.
Inclusion of additional documentation for impurities.
Variazione Tipo IB n.B.I.b.2.e: Change in test procedure for active
substance or starting material/reagent/intermediate used in the
manufacturing process of the active substance. Other changes to a
test procedure (including replacement or addition) or the active
substance or a starting material/intermediate - Method validation for
assay.
Variazione Tipo IB n.B.I.b.2.e: Change in test procedure for active
substance or starting material/reagent/intermediate used in the
manufacturing process of the active substance. Other changes to a
test procedure (including replacement or addition) or the active
substance or a starting material/intermediate - Method validation for
related substances.
Variazione Tipo IB n.B.I.b.2.e: Change in test procedure for active
substance or starting material/reagent/intermediate used in the
manufacturing process of the active substance. Other changes to a
test procedure (including replacement or addition) or the active
substance or a starting material/intermediate - Method validation for
residual solvents.
Variazione Tipo IB n.B.I.d.1.a)4. Change in re-test period/storage
period or storage conditions of the active substance where no Ph.
Eur. Certificate of Suitability covering the retest period is part of
the approved dossier.
Re-test period/storage period. Extension or introduction of a
re-test period/storage period supported by real time data. -Extention
re-test period from 36 to 60 months.
MPR DK/H/1384/001/IB/010/G - Codice Pratica C1B/2011/2079
Variazione Tipo IB n. B.II.b.3.z: Change in the manufacturing
process of the finished product. Minor change in the manufacturing
process of eye drops, solution - Change in amount of poly(vinyl
alcohol) solution.
Variazione Tipo IB n. B.II.b.3.z: Change in the manufacturing
process of the finished product. Minor change in the manufacturing
process of eye drops, solution - Change in amount of bulk solution
used for filter saturation MPR DK/H/1384/001/IA/011/G - Codice
Pratica C1A/2011/1916
Variazione Tipo IA n.B.II.d.2.a: Change in test procedure for the
finished product. Minor changes to an approved test procedure -
change in preparation of test/reference solution for determination of
assay and related substances
Variazione Tipo IA n.B.II.d.2.a: Change in test procedure for the
finished product. Minor changes to an approved test procedure - test
solution for determination of Benzalkonium chloride assay is now
filtrated
Variazione Tipo IA n.: B.II.d.2.a: Change in test procedure for the
finished product. Minor changes to an approved test procedure- Change
in reference
Dodecyl Bromide to Dodecyl Chloride(Benzyldimethyl dodecyl ammonium
chloride)
MPR DK/H/1384/001/IB/012/G - Codice Pratica C1B/2011/2078
Variazione Tipo IB n B.II.b.1.f: Replacement or addition of a
manufacturing site for part or all of the manufacturing process of
the finished product.
Site where any manufacturing operation(s) take place, except batch
release, batch control, and secondary packaging, for sterile
medicinal products manufactured using an aseptic method excluding
biological/ immunological medicinal product.
Variazione Tipo IB n B.II.b.1.b: Replacement or addition of a
manufacturing site for part or all of the manufacturing process of
the finished product.
Primary packaging site.
Variazione Tipo IAin n. B.II.b.1.a: Replacement or addition of a
manufacturing site for part or all of the manufacturing process of
the finished product. Secondary packaging site.
Variazione Tipo IAin: B.II.b.2.2: Change to batch release
arrangements and quality control testing of finished product
including batch control/testing.
Variazione Tipo IB n. B.II.b.4.a: Change in the batch size
(including batch size ranges) of the finished product up to 10-fold
compared to the currently approved batch size.
I lotti già prodotti sono mantenuti in commercio fino alla data di
scadenza indicata in etichetta.
Decorrenza delle modifiche: dal giorno successivo alla data della
loro pubblicazione in Gazzetta Ufficiale.

Il procuratore speciale
dott. Maurizio De Clementi


T12ADD8396