Parte Seconda n. 90 del 31-7-2010
Altri annunzi
Specialita' medicinali, presidi sanitari e medico chirurgici
DR. WILLMAR SCHWABE GMBH &amp; CO. KG
(GU Parte Seconda n.90 del 31-7-2010)

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

Titolare AIC: Dr. Willmar Schwabe GmbH &amp; Co. KG, con sede in
Willmar-Schwabe-Str. 476227 Karlsruhe Germany,
Specialità Medicinale: PROSTAPLANT
Confezioni e numero AIC:
160 mg + 120 mg capsule molli, 20 CAPSULE - AIC n. 033888037
160 mg + 120 mg capsule molli, 90 CAPSULE - AIC n. 033888076
160 mg + 120 mg capsule molli, 120 CAPSULE - AIC n. 033888088
160 mg + 120 mg capsule molli, 45 CAPSULE - AIC n. 033888052
160 mg + 120 mg capsule molli, 60 CAPSULE - AIC n. 033888064
160 mg + 120 mg capsule molli, 14 CAPSULE - AIC n. 033888013
160 mg + 120 mg capsule molli, 15 CAPSULE - AIC n. 033888025
160 mg + 120 mg capsule molli, 30 CAPSULE - AIC n. 033888049
Codice Pratica N1A/2010/4763
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.III.2) Change to comply with Ph. Eur. c) Change
in specifications from a national pharmacopoeia of a Member State to
the Ph. Eur: The specifications for Urtica extract were changed from
DAB to Ph.Eur.
Codice Pratica N1A/2010/4764
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.I.b.2) Change in test procedure for active
substance or starting material/reagent/intermediate used in the
manufacturing process of the active substance a) Minor changes to an
approved test procedure: Urtica extract - The test method for
determination of content (Scopoletin) has been updated
Codice Pratica N1A/2010/4765
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.I.b.2) Change in test procedure for active
substance or starting material/reagent/intermediate used in the
manufacturing process of the active substance a) Minor changes to an
approved test procedure: Update of the analytical method for
Determination of residual solvents (ethanol) in Urtica Extract
Codice Pratica N1A/2010/4770
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.I.b.2) Change in test procedure for active
substance or starting material/reagent/intermediate used in the
manufacturing process of the active substance a) Minor changes to an
approved test procedure: Update of the analytical method for
Determination of residual solvents (ethanol) in Sabal Extract
Codice Pratica N1A/2010/4782
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.I.b.1) Change in the specification parameters of
an active substance, starting material /intermediate / reagent used
in the manufacturing process of the active substance, c) Addition of
a new specification parameter with its corresponding test method:
Determination of the content of lauric acid methyl ester (quality)
and determination of peroxide value (stability) - Sabal Extract
Codice Pratica N1A/2010/4786
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IAIN B.III.2) Change to comply with Ph. Eur. a)
Change of specification(s) to comply with the Ph. Eur. 1) Active
substance - Specifications for Sabal drug were adapted to the Ph.
Eur. monograph "Saw palmetto fruit".
Codice Pratica N1A/2010/4787
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.I.a.4) Change to in-process tests or limits
applied during the manufacture of the active substance, b) Addition
of a new in-process test and limits: Sabal Extract - IP-parameter and
limits for Ethanol content were added
Codice Pratica N1A/2010/4788
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.I.a.2) Changes in the manufacturing process of
the active substance, a) Minor change: extraction times were
specified, Step 1: 20 - 30 h Step 2: 12 h
Codice Pratica N1A/2010/4783
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IAIN B.II.a.3) Changes in the composition
(excipients) of the finished product, a) Changes in components of the
colouring system, 2) Increase or reduction: Change in component of
the colour pigment of the capsule shell: Patent Blue (E131)
Codice Pratica N1A/2010/4767
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IAIN B.I.a.1) Change in the manufacturer of a
starting material/reagent/intermediate used in the manufacturing
process of the active substance a) The proposed manufacturer is part
of the same pharmaceutical group as the currently approved
manufacturer: (Urtica extract). Finzelberg GmbH &amp; Co. KG Koblenzer
Strasse 48 - 56, 56626 Andernach (Germany)
Codice Pratica N1A/2010/4768
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.I.d.1) Change in the storage conditions of the
active substance where no Ph. Eur. Certificate of Suitability
covering the retest period is part of the approved dossier, b.1)
Change to more restrictive storage conditions of the active
substance: (Sabal extract) the Herbal preparation should not be
stored above 30° C.
Codice Pratica N1A/2010/4771
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.II.b.5) Change to in-process tests applied
during the manufacture of the finished product, c) Deletion of a
non-significant in-process test: capsule format and dimensions.
Codice Pratica N1A/2010/4769
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.II.d.2) Change in test procedure for the
finished product, a) Minor changes to an approved test procedure: The
test method for identity of dry extract of stinging nettle roots has
been updated
Codice Pratica N1A/2010/4766
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IA B.II.d.2) Change in test procedure for the
finished product, a) Minor changes to an approved test procedure: The
test method for identity of Extract of saw palmetto fruits has been
changed.
Codice Pratica N1B/2010/3157
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IB B.II.f.1d)Change in storage conditions of the
finished product: Addition of a remark that the finished product
should not be stored above 30 °C.
Codice Pratica N1B/2010/3158
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IB B.I.d.1.a) Change in the re-test period/storage
period where no Ph. Eur. Certificate of Suitability covering the
retest period is part of the approved dossier, 4) Extension or
introduction of a re-test period/storage period supported by real
time data: Urtica extract 3 years
Codice Pratica N1B/2010/3152
Modifica apportata ai sensi del Regolamento (CE) 1234/2008
variazione Tipo IB B.II.d.2) Change in test procedure for the
finished product, d) Other changes to a test procedure (including
replacement or addition): The test method for determination of
content of extract of saw palmetto fruits has been replaced
Codice Pratica N1A/2010/4780
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, b) Downscaling down to 10-fold: Additional batch size of
499.244 kg Drug Product to the one already authorised, 1464.447 kg
Drug Product
I lotti già 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 &amp; Scientific Affairs
Dr. U. Mathes


T10ADD8630