Comunicazione notifica regolare V&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 gia' 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