Estratto determina AAM/PPA n. 535/2020 del 17 settembre 2020
Trasferimento di titolarita':
AIN/2020/1380
MC1/2020/4
L'autorizzazione all'immissione in commercio dei sotto elencati medicinali, in tutte le confezioni attualmente autorizzate, fino ad ora intestata alla societa' Ranbaxy Italia S.p.a., con sede legale in piazza Filippo Meda, 3, 20121 Milano, codice fiscale 04974910962.
=================================================
| Denominazione del medicinale | A.I.C. n. |
+=================================+=============+
|Aciclovir Ranbaxy |032927 |
+---------------------------------+-------------+
|Alendronato Ranbaxy Italia |038006 |
+---------------------------------+-------------+
|Alfuzosina Ranbaxy |038661 |
+---------------------------------+-------------+
|Alprazolam Ranbaxy |034979 |
+---------------------------------+-------------+
|Amoxicillina e Acido Clavulanico | |
|Ranbaxy Italia |041933 |
+---------------------------------+-------------+
|Amoxicillina e Acido Clavulanico | |
|Ranbaxy |037034 |
+---------------------------------+-------------+
|Amoxicillina Ranbaxy |035222 |
+---------------------------------+-------------+
|Atorvastatina Ranbaxy |040678 |
+---------------------------------+-------------+
|Bicalutamide Ranbaxy |038803 |
+---------------------------------+-------------+
|Bicalutamide Ranbaxy Italia |038586 |
+---------------------------------+-------------+
|Bromazepam Ranbaxy |035967 |
+---------------------------------+-------------+
|Carvedilolo Ranbaxy |036338 |
+---------------------------------+-------------+
|Ceftriaxone Ranbaxy |035905 |
+---------------------------------+-------------+
|Celecoxib Ranbaxy |042765 |
+---------------------------------+-------------+
|Cetirizina Ranbaxy |037653 |
+---------------------------------+-------------+
|Ciprofloxacina Ranbaxy |037584 |
+---------------------------------+-------------+
|Citalopram Ranbaxy |037111 |
+---------------------------------+-------------+
|Citalopram Ranbaxy Italia |036651 |
+---------------------------------+-------------+
|Claritromicina Ranbaxy |037527 |
+---------------------------------+-------------+
|Claritromicina Ranbaxy Italia |037586 |
+---------------------------------+-------------+
|Delorazepam Ranbaxy |036425 |
+---------------------------------+-------------+
|Donepezil Ranbaxy |040538 |
+---------------------------------+-------------+
|Doxazosina Ranbaxy |037245 |
+---------------------------------+-------------+
|Enalapril e Idroclorotiazide | |
|Ranbaxy |038039 |
+---------------------------------+-------------+
|Escitalopram Ranbaxy Italia |041647 |
+---------------------------------+-------------+
|Escitalopram Ranbaxy |042458 |
+---------------------------------+-------------+
|Esomeprazolo Ranbaxy |040839 |
+---------------------------------+-------------+
|Finasteride Ranbaxy |037963 |
+---------------------------------+-------------+
|Fluconazolo Ranbaxy |037900 |
+---------------------------------+-------------+
|Fosfomicina Ranbaxy |037272 |
+---------------------------------+-------------+
|Gabapentin Ranbaxy |038346 |
+---------------------------------+-------------+
|Gentamicina Ranbaxy |036129 |
+---------------------------------+-------------+
|Gentamicina e Betametasone | |
|Ranbaxy |036540 |
+---------------------------------+-------------+
|Gliclazide Ranbaxy |043644 |
+---------------------------------+-------------+
|Imatinib Ranbaxy |043126 |
+---------------------------------+-------------+
|Imipenem e Cilastatina Ranbaxy |039449 |
+---------------------------------+-------------+
|Irbesartan Ranbaxy |040818 |
+---------------------------------+-------------+
|Lansoprazolo Ranbaxy |037529 |
+---------------------------------+-------------+
|Lercanidipina Ranbaxy |039249 |
+---------------------------------+-------------+
|Levofloxacina Ranbaxy |040250 |
+---------------------------------+-------------+
|Lorazepam Ranbaxy |035772 |
+---------------------------------+-------------+
|Lormetazepam Ranbaxy |036285 |
+---------------------------------+-------------+
|Losartan Ranbaxy |039225 |
+---------------------------------+-------------+
|Losartan e Idroclorotiazide | |
|Ranbaxy |039677 |
+---------------------------------+-------------+
|Montelukast Ranbaxy |040631 |
+---------------------------------+-------------+
|Nebivololo Ranbaxy |038525 |
+---------------------------------+-------------+
|Nimesulide Ranbaxy |033702 |
+---------------------------------+-------------+
|Omeprazolo Ranbaxy Italia |040880 |
+---------------------------------+-------------+
|Pantoprazolo Ranbaxy |039015 |
+---------------------------------+-------------+
|Paroxetina Ranbaxy Italia |038931 |
+---------------------------------+-------------+
|Perindopril Ranbaxy |038523 |
+---------------------------------+-------------+
|Pravastatina Ranbaxy |037613 |
+---------------------------------+-------------+
|Pregabalin Ranbaxy |043571 |
+---------------------------------+-------------+
|Rabeprazolo Ranbaxy |040938 |
+---------------------------------+-------------+
|Ramipril Ranbaxy Italia |042262 |
+---------------------------------+-------------+
|Ramipril e Idroclorotiazide | |
|Ranbaxy |042745 |
+---------------------------------+-------------+
|Ranitidina Ranbaxy Italia |035397 035398|
+---------------------------------+-------------+
|Sertralina Ranbaxy |036600 |
+---------------------------------+-------------+
|Sildenafil Ranbaxy |040154 |
+---------------------------------+-------------+
|Simvastatina Ranbaxy |037134 |
+---------------------------------+-------------+
|Tamsulosina Ranbaxy |037483 |
+---------------------------------+-------------+
|Valsartan Ranbaxy |040617 |
+---------------------------------+-------------+
|Valsartan e Idroclorotiazide | |
|Ranbaxy |040842 |
+---------------------------------+-------------+
|Venlafaxine Ranbaxy Generici |041697 |
+---------------------------------+-------------+
e' ora trasferita alla societa' Sun Pharmaceutical Industries (Europe) B.V., con sede legale in Polaris Avenue 87, 2132 JH, B.V. 1441408 Olanda.
Con variazione delle denominazioni come di seguito indicato:
===================================================================== | Da | A | +================================================+==================+ |Aciclovir Ranbaxy N1B/2020/9 |Aciclovir Sun | +------------------------------------------------+------------------+ |Alendronato Ranbaxy Italia C1B/2020/510 | | |DE/H/6238/01/DC |Alendronato Sun | +------------------------------------------------+------------------+ |Alfuzosina Ranbaxy C1B/2020/465 NL/H/1327/001/MR|Alfuzosina Sun | +------------------------------------------------+------------------+ |Alprazolam Ranbaxy N1B/2020/10 |Alprazolam Sun | +------------------------------------------------+------------------+ | |Amoxicillina e | |Amoxicillina e Acido Clavulanico Ranbaxy Italia |Acido Clavulanico | |C1B/2020/476 PT/H/0727/001/DC |Sun | +------------------------------------------------+------------------+ | |Amoxicillina e | |Amoxicillina e Acido Clavulanico Ranbaxy |Acido Clavulanico | |N1B/2020/12 |Sun Pharma | +------------------------------------------------+------------------+ |Amoxicillina Ranbaxy N1B/2020/11 |Amoxicillina Sun | +------------------------------------------------+------------------+ |Atorvastatina Ranbaxy C1B/2020/277 | | |MT/H/0125/001-004/DC |Atorvastatina Sun | +------------------------------------------------+------------------+ |Bicalutamide Ranbaxy C1B/2020/119 |Bicalutamide Sun | |IT/H/0612/001/DC |Pharma | +------------------------------------------------+------------------+ | |Bicalutamide Sun | |Bicalutamide Ranbaxy Italia C1B/2020/120 |Pharmaceutical | |IT/H/0557/001/MR |Industries Limited| +------------------------------------------------+------------------+ |Bromazepam Ranbaxy N1B/2020/13 |Bromazepam Sun | +------------------------------------------------+------------------+ |Carvedilolo Ranbaxy N1B/2020/14 |Carvedilolo Sun | +------------------------------------------------+------------------+ |Ceftriaxone Ranbaxy N1B/2020/15 |Ceftriaxone Sun | +------------------------------------------------+------------------+ |Celecoxib Ranbaxy C1B/2020/424 | | |IT/H/0337/001-002/DC |Celecoxib Sun | +------------------------------------------------+------------------+ |Cetirizina Ranbaxy N1B/2020/19 |Cetirizina Sun | +------------------------------------------------+------------------+ |Ciprofloxacina Ranbaxy C1B/2020/142 | | |IT/H/0678/01-02-03/MR |Ciprofloxacina Sun| +------------------------------------------------+------------------+ |Citalopram Ranbaxy C1B/2020/198 | | |IT/H/0642/01-02-03/MR |Citalopram Sun | +------------------------------------------------+------------------+ | |Citalopram Sun | |Citalopram Ranbaxy Italia N1B/2020/16 |Pharma | +------------------------------------------------+------------------+ | |Claritromicina Sun| |Claritromicina Ranbaxy C1B/2020/195 |Pharmaceutical | |IT/H/0720/001-002/MR |Industries Limited| +------------------------------------------------+------------------+ |Claritromicina Ranbaxy Italia C1B/2019/3293 |Claritromicina Sun| |PL/H/0619/001-002/MR |Pharma | +------------------------------------------------+------------------+ |Delorazepam Ranbaxy N1B/2020/17 |Delorazepam Sun | +------------------------------------------------+------------------+ |Donepezil Ranbaxy C1B/2020/216 | | |DE/H/5686/01-02/MR |Donepezil Sun | +------------------------------------------------+------------------+ |Doxazosina Ranbaxy N1B/2020/33 |Doxazosina Sun | +------------------------------------------------+------------------+ | |Enalapril e | | |Idroclorotiazide | |Enalapril e Idroclorotiazide Ranbaxy N1B/2020/20|Sun | +------------------------------------------------+------------------+ |Escitalopram Ranbaxy Italia C1B/2020/504 |Escitalopram Sun | |NL/H/2514/001/DC |Pharma | +------------------------------------------------+------------------+ |Escitalopram Ranbaxy C1B/2020/512 | | |DE/H/5384/002/MR |Escitalopram Sun | +------------------------------------------------+------------------+ | |Esomeprazolo Sun | | |Pharmaceutical | |Esomeprazolo Ranbaxy C1B/2020/638 |Industries | |NL/H/4854/001-002/DC |(Europe) BV | +------------------------------------------------+------------------+ |Finasteride Ranbaxy C1B/2020/210 IT/H/493/001/MR|Finasteride Sun | +------------------------------------------------+------------------+ |Fluconazolo Ranbaxy N1B/2020/21 |Fluconazolo Sun | +------------------------------------------------+------------------+ |Fosfomicina Ranbaxy N1B/2020/22 |Fosfomicina Sun | +------------------------------------------------+------------------+ |Gabapentin Ranbaxy C1B/2020/145 | | |DE/H/616/001-003/MR |Gabapentin Sun | +------------------------------------------------+------------------+ |Gentamicina Ranbaxy N1B/2020/36 |Gentamicina Sun | +------------------------------------------------+------------------+ | |Gentamicina e | |Gentamicina e Betametasone Ranbaxy N1B/2020/23 |Betametasone Sun | +------------------------------------------------+------------------+ |Gliclazide Ranbaxy C1B/2020/385 NL/H/3853/001/DC|Gliclazide Sun | +------------------------------------------------+------------------+ |Imipenem e Cilastatina Ranbaxy CIB/2020/389 |Imipenem e | |LV/H/0163/001/DC |Cilastatina Sun | +------------------------------------------------+------------------+ |Irbesartan Ranbaxy C1B/2020/466 | | |NL/H/1242/001-003/DC |Irbesartan Sun | +------------------------------------------------+------------------+ |Lansoprazolo Ranbaxy C1B/2020/141 | | |IT/H/0471/001-002/MR |Lansoprazolo Sun | +------------------------------------------------+------------------+ |Lercanidipina Ranbaxy C1B/2020/205 | | |IT/H/0280/01-02/DC |Lercanidipina Sun | +------------------------------------------------+------------------+ |Levofloxacina Ranbaxy C1B/2020/196 | | |IT/H/0294/01-02/DC |Levofloxacina Sun | +------------------------------------------------+------------------+ |Lorazepam Ranbaxy N1B/2020/24 |Lorazepam Sun | +------------------------------------------------+------------------+ |Lormetazepam Ranbaxy N1B/2020/25 |Lormetazepam Sun | +------------------------------------------------+------------------+ |Losartan Ranbaxy C1B/2020/197 | | |IT/H/0671/001-002/MR |Losartan Sun | +------------------------------------------------+------------------+ | |Losartan e | |Losartan e Idroclorotiazide Ranbaxy C1B/2020/201|Idroclorotiazide | |IT/H/0585/01-02/DC |Sun | +------------------------------------------------+------------------+ |Montelukast Ranbaxy C1B/2020/224 | | |ES/H/0673/001/DC |Montelukast Sun | +------------------------------------------------+------------------+ |Nebivololo Ranbaxy C1B/2020/200 IT/H/0272/001/DC|Nebivololo Sun | +------------------------------------------------+------------------+ |Nimesulide Ranbaxy N1B/2020/26 |Nimesulide Sun | +------------------------------------------------+------------------+ |Omeprazolo Ranbaxy Italia C1B/2020/500 | | |DE/H/4299/001-002/DC |Omeprazolo Sun | +------------------------------------------------+------------------+ | |Pantoprazolo Sun | |Pantoprazolo Ranbaxy C1B/2020/497 - C1B/2020/498|Pharmaceutical | |DE/H/0866/001-002/DC |Industries Limited| +------------------------------------------------+------------------+ |Paroxetina Ranbaxy Italia C1B/2020/202 | | |IT/H/0246/001/DC |Paroxetina Sun | +------------------------------------------------+------------------+ |Perindopril Ranbaxy C1B/2020/361 | | |NL/H/0977/002-003/DC |Perindopril Sun | +------------------------------------------------+------------------+ |Pravastatina Ranbaxy C1B/2020/305 | | |DE/H/1812/001-003/MR |Pravastatina Sun | +------------------------------------------------+------------------+ |Pregabalin Ranbaxy C1B/2020/153 | | |IT/H/0477/001-008/DC |Pregabalin Sun | +------------------------------------------------+------------------+ |Rabeprazolo Ranbaxy C1B/2020/433 | | |FR/H/0584/001-002/DC |Rabeprazolo Sun | +------------------------------------------------+------------------+ |Ramipril Ranbaxy Italia C1B/2020/411 | | |FR/H/530/001-004/DC |Ramipril Sun | +------------------------------------------------+------------------+ | |Ramipril e | |Ramipril e Idroclorotiazide Ranbaxy C1B/2020/215|Idroclorotiazide | |IT/H/0313/001-002/DC |Sun | +------------------------------------------------+------------------+ |Ranitidina Ranbaxy Italia C1B/2020/208 | | |IT/H/0502/001-002/MR |Ranitidina Sun | +------------------------------------------------+------------------+ |Sertralina Ranbaxy C1B/2020/382 | | |SE/H/1847/001-002/MR |Sertralina Sun | +------------------------------------------------+------------------+ |Sildenafil Ranbaxy C1B/2020/514 | | |DE/H/4714/02-03/DC |Sildenafil Sun | +------------------------------------------------+------------------+ |Simvastatina Ranbaxy C1B/2020/387 | | |SE/H/1433/001-003/MR |Simvastatina Sun | +------------------------------------------------+------------------+ |Tamsulosina Ranbaxy C1B/2020/227 | | |DE/H/5628/001/MR |Tamsulosina Sun | +------------------------------------------------+------------------+ | |Valsartan e | |Valsartan e Idroclorotiazide Ranbaxy |Idroclorotiazide | |C1B/2020/284 DE/H/5277/001-003/DC |Sun | +------------------------------------------------+------------------+ |Venlafaxine Ranbaxy Generici C1B/2020/380 | | |FR/H/0505/002-003/DC |Venlafaxine Sun | +------------------------------------------------+------------------+
Stampati
Il titolare dell'autorizzazione all'immissione in commercio dei medicinali sopraindicati deve apportare le necessarie modifiche al riassunto delle caratteristiche del prodotto dalla data di entrata in vigore della determina, di cui al presente estratto, ed al foglio illustrativo ed alle etichette dal primo lotto di produzione successivo all'entrata in vigore della presente determina.
In ottemperanza all'art. 80, commi 1 e 3 del decreto legislativo 24 aprile 2006, n. 219 e successive modificazioni ed integrazioni, il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio nella Provincia di Bolzano, anche in lingua tedesca.
Il titolare dell'A.I.C. che intende avvalersi dell'uso complementare di lingue estere deve darne preventiva comunicazione all'AIFA e tenere a disposizione la traduzione giurata dei testi in lingua tedesca e/o in altra lingua estera.
In caso di inosservanza delle disposizioni sull'etichettatura e sul foglio illustrativo si applicano le sanzioni di cui all'art. 82 del suddetto decreto legislativo.
Smaltimento scorte
I lotti dei medicinali, gia' prodotti e rilasciati a nome del precedente titolare alla data di entrata in vigore della determina, di cui al presente estratto, possono essere mantenuti in commercio fino alla data di scadenza indicata in etichetta.
Proroga della commercializzazione dei lotti gia' prodotti e non ancora rilasciati.
E' autorizzata la proroga della commercializzazione, con foglio illustrativo ed etichette non aggiornate, dei seguenti lotti gia' prodotti e non ancora rilasciati alla data di entrata in vigore della determina, di cui al presente estratto:
===================================================================== | | A.I.C. | | | Medicinale |confezione| Lotti | +==============+==========+=========================================+ |Claritro- | | | |micina Ranbaxy| | | |Italia «500 mg| | | |compresse | | | |rivestite con | | | |film» 14 | | | |compresse in | | | |blister | | | |PVC/PVDC/AL |037586144 | AB40869 | +--------------+----------+-----------------------------------------+ |Escitalopram | | | |Ranbaxy «10 mg| | | |compresse | | | |rivestite con | | | |film» 28 | | | |compresse in | | | |blister | | | |PA/AL/PVC/AL |042458036 | AB40907 | +--------------+----------+-----------------------------------------+ |Esomeprazolo | | | |Ranbaxy «20 mg| | | |compresse | | | |gastro- | | | |resistenti» 28| | | |compresse in | | | |blister | | | |OPA/AL/PVC/AL |040839223 | AB46750 | +--------------+----------+-----------------------------------------+ |Gliclazide | | | |Ranbaxy «60 mg| | | |compresse a | | | |rilascio | | | |modificato» 30| | | |compresse in | | | |blister | | | |PVC/PE/PVDC/AL|043644044 | AB39259 AB62260 AB62261 AB62264 AB62265 | +--------------+----------+-----------------------------------------+ |Losartan | | | |Ranbaxy «100 | | | |mg compresse | | | |rivestite con | | | |film» 28 | | | |compresse in | | | |blister | | | |OPA/AL/PVC/AL |039225115 | AB41360 | +--------------+----------+-----------------------------------------+ |Montelukast | | | |Ranbaxy «10 mg| | | |compresse | | | |rivestite con | | | |film» 28 | | | |compresse in | | | |blister | | | |PA/AL/PVC/AL |040631020 | AB42930 | +--------------+----------+-----------------------------------------+ |Omeprazolo | | | |Ranbaxy Italia| | | |«10 mg capsule| | | |rigide gastro-| | | |resistenti» 28| | | |capsule in | | | |flacone HDPE |040880371 | AB27970 | +--------------+----------+-----------------------------------------+ |Omeprazolo | | | |Ranbaxy Italia| | | |«20 mg capsule| | | |rigide gastro-| | | |resistenti» 28| | | |capsule in | | | |flacone HDPE |040880217 | AB35532 AB44165 | +--------------+----------+-----------------------------------------+ |Omeprazolo | | | |Ranbaxy Italia| | | |«20 mg capsule| | | |rigide gastro-| | | |resistenti» 14| | | |capsule in | | | |flacone HDPE |040883243 | AB56942 | +--------------+----------+-----------------------------------------+ |Pantoprazolo | | | |Ranbaxy «20 mg| | | |compresse | | | |gastro- | | | |resistenti» 28| | | |compresse in | | | |blister | | | |ALU/ALU |039015045 | AB60504 AB28691 | +--------------+----------+-----------------------------------------+ |Pantoprazolo | | | |Ranbaxy «40 mg| | | |compresse | | | |gastro- | | | |resistenti» 28| | | |compresse in | | | |blister | | | |ALU/ALU |039015159 | AB59968 AB27392 | +--------------+----------+-----------------------------------------+ |Perindopril | | | |Ranbaxy «4 mg | | | |compresse» 30 | | | |compresse in | | | |blister | | | |PA/AL/PVC-AL |038523078 | AB19260 | +--------------+----------+-----------------------------------------+ |Pregabalin | | | |Ranbaxy «25 mg| | | |capsule | | | |rigide» 14 | | | |capsule in | | | |blister PVC/AL|043571013 | AB26318 | +--------------+----------+-----------------------------------------+
===================================================================== | | A.I.C. | | | Medicinale | confezione | Lotti | +==========================+================+=======================+ |Ramipril Ranbaxy Italia | | | |«10 mg compresse» 28 | | | |compresse in blister | | | |OPA/AL/PVC/AL | 042262194 | AB18924 AB28250 | +--------------------------+----------------+-----------------------+ |Ramipril Ranbaxy Italia | | | |«2,5 mg compresse» 28 | | | |compresse in blister | | | |OPA/AL/PVC/AL | 042262016 | AB20123 AB70943 | +--------------------------+----------------+-----------------------+ |Ramipril Ranbaxy Italia «5| | | |mg compresse» 14 compresse| | | |in blister OPA/AL/PVC/AL | 042262093 | AB31953 | +--------------------------+----------------+-----------------------+ |Sildenafil Ranbaxy «50 mg | | | |compresse rivestite con | | | |film» 4 compresse in | | | |blister PVC/PE/PVDC | 040154104 | AB20989 AB67392 | +--------------------------+----------------+-----------------------+ |Valsartan e | | | |Idroclorotiazide Ranbaxy | | | |«160 mg/12.5 mg compresse | | | |rivestite con film» 28 | | | |compresse in blister AL/AL| 040842142 | AB04262 | +--------------------------+----------------+-----------------------+
I lotti sopracitati possono essere mantenuti in commercio fino alla data di scadenza indicata in etichetta.
Decorrenza di efficacia della determina: dal giorno successivo a quello della sua pubblicazione, per estratto, nella Gazzetta Ufficiale della Repubblica italiana.
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