Parte Seconda n. 2 del 5-1-2017
Altri annunzi
Specialita' medicinali, presidi sanitari e medico chirurgici
ANGENERICO S.P.A.
Sede legale: via Nocera Umbra, 75 - Roma Partita IVA: 07287621002
(GU Parte Seconda n.2 del 5-1-2017)

Comunicazione notifica regolare V&amp;A


Medicinale: CEFTRIAXONE ANGENERICO 1 g / 3,5 ml polvere e solvente
per soluzione iniettabile per uso intramuscolare.
Codice farmaco: 036095...
Codice Pratica N°. N1A/2016/960
Tipologia variazione oggetto della modifica: IA7
Tipo di modifica: Eliminazione di un sito produttivo (Chiapparoli
srl)
Medicinale: CEFTRIAXONE ANGENERICO 1 g / 3,5 ml polvere e solvente
per soluzione iniettabile per uso intramuscolare.
Codice farmaco: 036095...
Codice Pratica N°. N1A/2016/1314
Tipologia variazione oggetto della modifica: B.III.1.a.2. tipo IB
Tipo di modifica: Aggiornamento del certificate of Suitability per
il produttore già autorizzato FRESENIUS-KABI ANTI-INFECTIVES S.r.l.
da R1-CEP 2004-119-REV0 A R1-CEP 2004-119-REV05
Medicinale: IRBESARTAN ANGENERICO 75/150/300 mg compresse rivestite
co film
Codice farmaco: 040375...
Codice Pratica N°. C1A/2016/3122
Tipologia variazione oggetto della modifica:
AT/H/0203/001-002-003/IA/019 type IA, n. B.II.b.3.a
Tipo di modifica: Change in the manufacturing process of the
finished product, including an intermediate used in the manufacture
of the finished product. Minor change in the manufacturing process.
Medicinale: KETOPROFENE SALE DI LISINA ANGENERICO 80 granulato per
soluzione orale", 30 bustine bipartite
Codice farmaco: 038457...
Codice pratica: N1A/2016/2253
Tipologia di variazione oggetto della modifica: tipo IA7
Tipo di modifica: Eliminazione del sito produttivo di materia prima
Bidachem SpA.
Medicinale: LOSARTAN IDROCLOROTIAZIDE ANGENERICO 50 mg/12,5 mg e
100mg/25mg compresse rivestite con film
Codice farmaco: 039155...
Codice pratica: C1A/20166/1287
Tipologia di variazione oggetto della modifica: grouping variation
n. UK/H/1177/IA/030/G
Tipo di modifica: Replacement or addition of a manufacturing site
for part or all of the manufacturing process of the finished product.
Primary packaging site (type Iain, classification B.II.b.1.b).
Replacement or addition of a manufacturing site for part or all of
the manufacturing process of the finished product. Secondary
packaging site (type Iain, classification B.II.b.1.a).
Medicinale: LEVOFLOXACINA ANGENERICO 250/500 MG compresse rivestite
con film
Codice farmaco: 040217...
Codice pratica: C1A/2016/3696
Tipologia di variazione oggetto della modifica: grouping variation
n. UK/H/1302/IA/018/G
Tipo di modifica: Change in test procedure for active substance or
starting material/reagent/intermediate used in the manufacturing
process of the active substance. Minor changes to an approved test
procedure (type IA, n. B.I.b.2.a.).
Medicinale: SIMVASTATINA ANGENERICO 10/20/40 mg compresse rivestite
con film
Codice farmaco: 037528...
Codice pratica: C1B/2016/2827
Tipologia di variazione oggetto della modifica: grouping variation
n. DE/H/2046/IA/055/G
Tipo di modifica: Submission of a new or updated Ph. Eur.
Certificate of suitability or deletion of Ph. Eur. Certificate of
suitability: for an active substance, for a starting
material/reagent/intermediate used in the manufacturing process of
the active substance, for an excipient. European Pharmacopoeial
Certificate of Suitability to the relevant Ph. Eur. Monograph.
Updated certificate from an already approved manufacturer (type IA n.
B.III.1.a.2).Update of CEP of already approved API manufacturer TEVA
Pharmaceutical Industries for Simvastatin, proposed CEP version
R1-CEP 2010-130-REV 00 supersedes currently CEP version R0-CEP
2010-130-REV01.Submission of a new or updated Ph. Eur. Certificate of
suitability or deletion of Ph. Eur. Certificate of suitability: for
an active substance, for a starting material/reagent/intermediate
used in the manufacturing process of the active substance, for an
excipient. European Pharmacopoeial Certificate of Suitability to the
relevant Ph. Eur. Monograph. Updated certificate from an already
approved manufacturer (type IB n. B.III.1.a.2).Variation includes an
update of CEP for already registered API manufacturer TEVA
Pharmaceutical Industries. Updated CEP version R1-CEP 2010-130-REV01
supersedes skipped version R1-CEP 2010-130-REV00.
Medicinale: SIMVASTATINA ANGENERICO 10/20/40 mg compresse rivestite
con film
Codice farmaco: 037528...
Tipologia di variazione oggetto della modifica: variazione n.
DE/H/2046/002/IA/057
Codice pratica: C1A/2016/3678
Tipo di modifica: Change in the manufacturing process of the
finished product, including an intermediate used in the manufacture
of the finished product. Minor change in the manufacturing process
(type IA, n. B.II.b.3.a.).
Medicinale: TRAMADOLO ANGENERICO (tutti i dosaggi e le confezioni)
Codice farmaco: 035918...
Tipologia di variazione oggetto della modifica: tipo IA7
Codice pratica: N1A/2016/1618
Tipo di modifica: Eliminazione di un sito produttivo (ACRAF SpA)
per alcune fasi di produzione.
Medicinale: GLIMEPIRIDE ANGENERICO 2 mg compresse
Codice farmaco: 036961...
Tipologia di variazione oggetto della modifica: grouping variation
n. DE/2142/IB/015/G
Codice pratica: C1B/2016/2898
Tipo di modifica: Submission of a new or updated Ph. Eur.
Certificate of Suitability or deletion of Ph. Eur. Certificate of
suitability: for an active substance, for a starting
material/reagent/intermediate used in the manufacturing process of
the active substance, for an excipient. European Pharmacopoeial
Certificate of Suitability to the relevant Ph. Eur. Monograph.
Updated certificate from an already approved manufacturer (type IA,
n. B.III.1.a).2).
Medicinale: AMLODIPINA ANGENERICO 5/10 mg compresse
Codice farmaco: 038096...
Tipologia di variazione oggetto della modifica: variazione n.
DK/H/0961/001-002/IA/057
Codice pratica: C1A/2016/2950
Tipo di modifica: Submission of a new updated Ph. Eur. Certificate
of suitability or deletion of Ph. Eur. Certificate of suitability:
for an active substance, for a starting material/reagent/intermediate
used in the manufacturing process of the active substance, for an
excipient-European Pharmacopoeial Certificate of Suitability to the
relevant Ph. Eur. Monograph: new certificate from a new manufacturer
(replacement or addition) (type IAIN, n. B.III.1.a.3.).Introduction
of a new drug substance manufacturer Cadila Healthcare Limited (291,
G.I.D.C.)Industrial Estate, Bhaaruc District, India-393 002
Ankleshwar, Guajarat) in addition to three already approved
manufacturers. Cadila Healthcare Limited is owner of a Certificate of
Suitability (CoS) CEP 2007-280. Currently valid version of CoS is
R1-CEP 2007-280-REV03.
Medicinale: SIMVASTATINA ANGENERICO 10/20/40 mg compresse rivestite
con film
Codice farmaco: 037528...
Tipologia di variazione oggetto della modifica:
DE/H/2046/001-002-004-006-007/IB/048
Codice pratica: N1B/2016/1218
Tipo di modifica: Change in manufacture of the Finished Product.
Other variation (type IB, n. B.II.B.Z).
Medicinale: SIMVASTATINA ANGENERICO 10/20/40 mg compresse rivestite
con film
Codice farmaco: 037528...
Codice pratica: C1A/2016/2169
Tipologia di variazione oggetto della modifica: DE/H/2046/IA/049/G
Tipo di modifica: Submission of a new or updated Eur. Certificate
of suitability or deletion of Ph. Eur. Certificate of suitability:
for an active substance/for a starting material/reagent/intermediate
used in the manufacturing process of the active substance /for an
excipient. European Pharmacopoeial Certificate of Suitability to the
relevant Ph. Eur. Monograph. Updated certificate from an already
approved manufacturer (type IA, n. B.III.1.a.2).
Update of CEP for already approved API manufacturer TEVA
Pharmaceutical Industries Ltd. For Simvastatin, proposed CEP version
R1-CEP 2010-130-REV 00 supersedes currently approved CEP version
R0-CEP 2010-130-REV 01. No change in manufacturing site and/or API
specification occurs from update of CEP.
Submission of a new or updated Eur. Certificate of suitability or
deletion of Ph. Eur. Certificate of suitability: for an active
substance/for a starting material/reagent/intermediate used in the
manufacturing process of the active substance /for an excipient.
European Pharmacopoeial Certificate of Suitability to the relevant
Ph. Eur. Monograph. Updated certificate from an already approved
manufacturer (type IA, n. B.III.1.a.2).
Update of CEP for already approved API manufacturer PKU HEALTHCARE
LIMITED CORP: The proposed version of CEP R0-CEP 2010-116-REV02
supersedes CEP version R0-CEP 2010-116-REV01, the updated CEP version
includes a change in name and address of CEP holder from PKU
HEALTHCARE LIMITED CORP to Southwest Synthetic Pharmaceutical Corp.
Ltd, in addition name of manufacturing site has changed from PKU
HEALTHCARE LIMITED CORP to Southwest Synthetic Pharmaceutical Corp
Ltd, too.
Medicinale: SIMVASTATINA ANGENERICO 10/20/40 mg compresse rivestite
con film
Codice farmaco: 037528...
Codice pratica: C1A/2016/2663
Tipologia di variazione oggetto della modifica:
DE/H/2046/001-007/IA/051
Tipo di modifica: Submission of a new or updated Eur. Certificate
of Suitability or deletion of Ph. Eur. Certificate of suitability:
For an active substance/for a starting material/reagent/intermediate
used in the manufacturing process of the active substance/for an
excipient. European Pharmacopoeial Certificate of Suitability to the
relevant Ph. Eur. Monograph. Updated certificate from an already
approved manufacturer (type IA, n.B.III.1. a. 2). Update of CEP of
already approved active pharmaceutical ingredient manufacturer PKU
HEALTHCARE Limited Corp. (China). Updated version of CEP R0-CEP
2010-116-REV02 supersedes currently approved CEP version n. R0-CEP
2010-116-REV01.
Decorrenza della modifica: dal giorno successivo alla data della
sua pubblicazione in G.U.

Il procuratore speciale
dott.ssa Mariangela Caretto


TX17ADD123