Treaty

Appendiċi

li hemm referenza għalih fil-Kapitolu 1 ta’ l-Anness VII

Il-lista kif provduta minn Ċipru f’lingwa waħda tal-prodotti farmaċewtiċi li għalihom awtorizzazzjoni għall-marketing li nħarġet taħt il-liġi ta’ Ċipru qabel id-data ta’ l-adeżjoni, għandha

tibqa’ valida sakemm tiġi mġedda b’konformità ma’ l-acquis jew sal-31 ta’ Diċembru 2005, skond liema tiġi l-ewwel.

Il-presenza fuq din il-lista ma tippreġudikax jekk il-prodott farmaċewtiku msemmi għandux awtorizzazzjoni għall-marketing bi qbil ma’ l-acquis jew le.

Il-listi mehmuża A u B jindikaw il-prodotti farmaċewtiċi għall-użu mill-bniedem u l-prodotti mediċinali veterinarji rispettivament, li bħalissa jinsabu fiċ-ċirkulazzjoni f’Ċipru. Dawn il-prodotti ngħataw l-awtorizzazzjoni jew il-liċenzja għall-marketing abbażi tal-leġislazzjoni qadima mhux armonizzata.

L-awtorizzazzjonijiet għall-marketing tal-prodotti farmaċewtiċi mniżżla kollha ser jiġġeddu (jekk

jitolbu hekk il-manufatturi u/jew l-importaturi) matul l-2004 u l-2005 skond id-disposizzjonijiet tal-

leġislazzjoni armonizzata ġdida, u eventwalment, dossiers armonizzati għal kollox ser jiġu magħmula sal-31 ta’ Diċembru 2005.

AA2003/ACT/Anness VII/mt 2625

LISTA A: PRODOTTI MEDIĊINALI GĦALL-UŻU MILL-BNIEDEM

CODE No PRODUCT 9900231 4-WAY NASAL FAST ACTING SPRAY 1% 9800571 5-FLUOROURACIL "EBEWE" VIALS 50MG/ML, 10ML 9800570 5-FLUOROURACIL "EBEWE" VIALS 50MG/ML, 5ML 9700037 -5-FLUOROURACIL INJECTION 50MG/ML 9800572 5-FLUOROURACIL"EBEWE" VIALS 50MG/ML, 20ML 20050619 99F0165 HAIR & NAILCARE CAPSULES

97F0150 ABC SPEKTRUM TABLETS

9800252 ABERNIL TABLETS 50MG

9800550 AB-HYOSCINE BUTYLBROMIDE INJECTION 20MG/ML 9900615 ACARILBIAL LIQUID

8700493 ACEPROTIN TABLETS 25MG

8700492 ACEPROTIN TABLETS 50MG

97F0154 ACEROLA TABLETS 500MG

9700217 ACETAZOLAMIDE TABLETS 250MG

9400248 ACETAZONE FORTE TABLETS

9500684 ACICLOVIR GOLGI CREAM 5% W/W

99F0042 ACIDOPHILUS CAPSULES 40MG

9500658 ACIDRINE TABLETS

8400119 ACTIFED DM COUGH LINCTUS SYRUP

8200220 ACTIFED EXPECTORANT SYRUP

8100193 ACTIFED TABLETS

9800445 ACTIVELLE TABLETS

8900382 ACTRAPID HM INJECTION 100IU/ML, 10ML VIALS 9400342 ACTRAPID HM PENFILL INJECTION 100IU/ML, 3ML CARTR 8900381 ACTRAPID HM PENFILL INJECTION 100IU/ML,1.5ML CARTR

AA2003/ACT/Anness VII/mt 2626

8500351 ACTRAPID MC INJECTION 100IU/ML, 10ML VIALS 9500243 ACUITEL FILM COATED TABLETS 10MG

9000392 ACUITEL FILM COATED TABLETS 20MG

9000391 ACUITEL FILM COATED TABLETS 5MG

9900565 ACYCLOVIR TABLETS 200MG

9900566 ACYCLOVIR TABLETS 400MG

9900567 ACYCLOVIR TABLETS 800MG

9900222 ADAFERIN GEL 0.1%

9600391 ADALAT CC COATED TABLETS 30MG

2000367 ADALAT LA TABLETS 30MG

2000368 ADALAT LA TABLETS 60MG

8600670 ADALAT RETARD SUSTAINED RELEASE TABLETS 20MG 8400620 ADD-ACTEN TABLETS

9800269 ADDITIVA CALCIUM EFFERVESCENT TABLETS 500MG 9800270 ADDITIVA ETSEN (Fe2+) EFFERVESCENT TABLETS 18MG 9800267 ADDITIVA MAGNESIUM EFFERVESCENT TABLETS 150MG 9500062 ADDITIVA VITAMIN C BLUTORANGE EFFERVESCENT TABLETS 9400204 ADENOCOR IV INJECTION 6MG/2ML

9600520 ADENOSAN SHAMPOO 2%

9900497 AD-MUC OINTMENT

9600447 ADVANTAN CREAM 1MG

9600446 ADVANTAN FATTY OINTMENT 1MG

9600448 ADVANTAN OINTMENT 1MG

9800554 ADVIL SUGAR COATED TABLETS 200MG

9900665 AGELMIN FILM COATED TABLETS 10MG

8000431 A-GEN VAGINAL SUPPOSITORIES

9800604 AGGRASTAT IV CONCENTRATE FOR INFUSION 0.25MG/ML 9400018 AGRIPPAL S1 INJECTION 0.5ML

9600519 AIDOL ORAL SUSP. 50MG/5ML

9200363 AIDOL TABLETS 500MG

9200138 AIRTAL TABLETS 100MG

8700541 AKAMON TABLETS 1.5MG

AA2003/ACT/Anness VII/mt 2627

7900048 AKINETON RETARD SUSTAINED RELEASE TABLETS 4MG

7900047 AKINETON TABLETS 2MG

9700548 AKNE-MYCIN EMULSION 1%

9700546 AKNE-MYCIN OINTMENT 2%

9700544 AKNE-MYCIN SOLUTION 2%

9700553 AKNEROXID GEL 5%

8400033 AKTIFERRIN-F SOFT GELATIN CAPSULES 9800454 ALBUMIN HUMAN INFUSION 20% 2000082 ALBUMIN HUMAN INFUSION 20%, 100ML 2000081 ALBUMIN HUMAN INFUSION 20%, 50ML 9900663 ALCITON NASAL SPRAY 0.02%

8900771 ALDACTONE TABLETS 100MG

8900778 ALDACTONE TABLETS 25MG

7700404 ALDIX TABLETS 40MG

9400497 ALFINOR TABLETS 8MG

9400351 ALFOXAN SYRUP 50MG/5ML

9600192 ALGAMEX CHEWABLE TABLETS 500MG 9500549 ALGESALONA CREAM

9500021 ALGIDOL SACHETS

2000146 ALLERGODIL EYE DROPS 0.05% 9400066 ALLERGODIL NASAL SPRAY 0.1% W/V 9600190 ALLERGOTIN EYE DROPS 2%

9600191 ALLERGOTIN EYE DROPS 4%

95F0507 ALLITHERA CAPSULES 500MG

8500222 ALLOPURINOL-RATIOPHARM TABLETS 300MG 9400303 ALLVORAN FILM COATED TABLETS 25MG 9400304 ALLVORAN FILM COATED TABLETS 50MG 9400305 ALLVORAN RETARD SUSTAINED RELEASE TABLETS 100MG

9400306 ALLVORAN S SUPPOSITORIES 100MG 9400307 ALLVORAN SF INJECTION 75MG/3ML 8400703 ALMIRAL ENTERIC COATED TABLETS 25MG

AA2003/ACT/Anness VII/mt 2628

8400704 ALMIRAL ENTERIC COATED TABLETS 50MG 8900321 ALMIRAL GEL 1% W/W

9000030 ALMIRAL INJECTION 25MG/ML, 3ML 8500461 ALMIRAL SUSTAINED RELEASE TABLETS 100MG 9700190 ALOMIDE EYE DROPS 0.1% W/V

9900064 ALPHAGAN EYE DROPS 0.2%

8500121 ALPHOSYL CREAM

8500123 ALPHOSYL HC CREAM

9900568 ALPRAZOLAM TABLETS 0.25MG

9500538 ALPRAZOLAM TABLETS 0.5MG

9900569 ALPRAZOLAM TABLETS 0.5MG

9500539 ALPRAZOLAM TABLETS 1MG

9900570 ALPRAZOLAM TABLETS 1MG

9000272 ALTEN CREAM 0.05%

9000574 ALUTRIL CHEWABLE TABLETS

9300401 ALVEOFACT VIALS

8400625 ALVERIX TABLETS 5MG

9500657 ALVITYL SYRUP

7500071 ALVOGYL PASTE

9800083 AMARIN CAPSULES 15MG

9300372 AMARIN CAPSULES 30MG

9600437 AMARYL TABLETS 1MG

9600438 AMARYL TABLETS 2MG

9600439 AMARYL TABLETS 3MG

8700532 AMBEN POWDER FOR ORAL SUSP. 250MG/5ML 8700533 AMBEN POWDER FOR ORAL SUSP. 500MG/5ML 9500046 AMBROHEXAL TABLETS 30MG

8800617 AMBROXOL-RATIOPHARM SUSTAINED RELEASE CAPSULES 75MG

8200373 AMEN TABLETS 100MG

8600268 AMILORID COMP TABLETS

8400311 AMILORIDE TABLETS 5MG

AA2003/ACT/Anness VII/mt 2629

9800314 AMILOZID-B TABLETS

8600091 AMINOPHYLLINE SUPPOSITORIES 360MG 9200111 AMINOPHYLLINE TABLETS 250MG

7600433 AMINOPLASMAL L-10 PARENTERAL SOLUTION 500ML 7600432 AMINOPLASMAL L-5 PARENTERAL SOLUTION 500ML 9700201 AMINOSTERIL INFUSION 10%

8300489 AMIODARONE TABLETS 200MG

8000536 AMIROL FILM COATED TABLETS 10MG

8000573 AMIROL FILM COATED TABLETS 25MG

9900443 AMITRIPTYLINE HCI TABLETS 10MG

9900444 AMITRIPTYLINE HCI TABLETS 25MG

9900445 AMITRIPTYLINE HCI TABLETS 50MG

9400453 AMODEX CAPSULES 500MG

9400455 AMODEX POWDER FOR RECONSTITUTION 250MG/5ML 9400456 AMODEX POWDER FOR RECONSTITUTION 500MG/5ML 9100074 AMODIAQUINE FILM COATED TABLETS 200MG 8100069 AMOXAPEN CAPSULES 250MG

9000233 AMOXICILLIN-RATIOPHARM 250TS POWDER FOR ORAL SUSP. 250MG/5ML

8900146 AMOXICILLIN-RATIOPHARM 500 FILM COATED TABLETS 500MG 7201303 AMOXIL CAPSULES 250MG

7201306 AMOXIL FORTE POWDER FOR ORAL SUSP. 250MG/5ML 7201304 AMOXIL PAEDIATRIC DROPS 100MG/ML

7700299 AMOXIL POWDER FOR INJECTION 250MG VIALS 7700300 AMOXIL POWDER FOR INJECTION 500MG VIALS 7201305 AMOXIL POWDER FOR ORAL SUSP. 125MG/5ML 9000114 AMOXIMEX POWDER FOR ORAL SUSP. 250MG/5ML 9000116 AMOXIMEX TABLETS 1000MG

9000115 AMOXIMEX TABLETS 500MG

9000209 AMOXY-DIOLAN POWDER FOR ORAL SUSPENSION 250MG/5ML 9100186 AMPICILLIN-VOGEN CAPSULES 500MG

9300414 AMPISUL CAPSULES 250MG

9300415 AMPISUL CAPSULES 500MG

AA2003/ACT/Anness VII/mt 2630

9500534 AMYZOL CAPSULES 50MG

2000188 ANABACT GEL 0.75% W/W

8800463 ANADIN TABLETS 500MG

9900358 ANAFRANIL INJECTION 25MG/2ML

9900372 ANAFRANIL SLOW RELEASE TABLETS DIVIDABLE 75MG 9900357 ANAFRANIL SUGAR COATED TABLETS 10MG 9900356 ANAFRANIL SUGAR COATED TABLETS 25MG 8500298 ANALGISER TABLETS 500MG

9300396 ANAVIX SYRUP 15MG/5ML

9300397 ANAVIX SYRUP 30MG/5ML

8400083 ANDRIOL CAPSULES 40MG

8300175 ANDROCUR TABLETS 10MG

8300176 ANDROCUR TABLETS 50MG

7100385 ANERVAN SUPPOSITORIES

7100384 ANERVAN TABLETS

9400085 ANFADOX CAPSULES 100MG

9900164 ANGINOVA TABLETS

2000046 ANTHISAN PLUS SPRAY

9800331 ANTIBIOPTAL EYE DROPS

9400290 ANTIFUNGOL CREAM 1%

8900553 ANTIKINAL TABLETS 5MG

2100049 ANTIPHLOGISTINE RUB A-535 CAPSAICIN GEL 2100048 ANTIPHLOGISTINE RUB A-535 EXTRA-STRENGTH OINTMENT

2100050 ANTIPHLOGISTINE RUB A-535 HEAT OINTMENT 2100047 ANTIPHLOGISTINE RUB A-535 ICE GEL 4% W/W 9400216 ANTISPASMINA COLICA FORTE TABLETS 8000418 ANTISTIN-PRIVIN EYE DROPS

7300136 ANUSOL OINTMENT

9500180 ANZATAX CONCENTRATE INJECTION 6MG/ML, 5ML 9500181 ANZATAX CONCENTRATE INJECTION 6MG/ML, 5ML VIAL 9700136 APONIL TABLETS 100MG

9900284 APRESOLINE' FILM COATED TABLETS 25MG

AA2003/ACT/Anness VII/mt 2631

9900283 APRESOLINE SUGAR COATED TABLETS 10MG 8000260 APROXAL CAPSULES 500MG

8000262 APROXAL POWDER FOR ORAL SUSP. 250MG/5ML 8000261 APROXAL POWDER FOR ORAL SUSPENSION 125MG/5ML 8200038 APROXAL POWDER FOR ORAL SUSPENSION 500MG/5ML 8400312 ARBAT FILM COATED TABLETS 200MG 8400313 ARBAT FILM COATED TABLETS 400MG 9900393 AREDIA POWDER FOR INJECTION 60MG WITH SOLVENT 9900392 AREDIA VIALS POWDER FOR INJECTION 90MG 9900522 ARESTON TABLETS 50MG

9400519 ARFAREL SOLUTION 10MG/ML

9800560 ARFEN PLUS TABLETS 500/50MG

8400422 ARFEN SUSP. 120MG/5ML

9800605 ARFEN TABLETS 100MG

7700497 ARFEN TABLETS 500MG

9600413 ARIMIDEX TABLETS 1MG

9800343 ARNETIN INJECTION 25MG/ML

9200036 ARNETIN TABLETS 150MG

2000480 ARNETIN TABLETS 300MG

9900526 AROMASIN SUGAR COATED TABLETS 25MG 8600580 ARPHOS VITAMIN B12 AMPOULES DRINKABLE 9000465 ARTHRINAL FILM COATED TABLETS 20MG 9700291 ARTHROTEC 75 TABLETS

9500087 ARTHROXEN TABLETS 250MG

9500088 ARTHROXEN TABLETS 500MG

8700174 ASACOL FILM COATED TABLETS 400MG 9400466 ASPEGIC 100 FOR CHILDREN AND INFANTS PDR 180MG IN SACHETS

9400465 ASPEGIC 1000 POWDER 1800MG IN SACHETS 9400463 ASPEGIC 500 PDR FOR INJ. 900MG VIAL WITH DILU

AA2003/ACT/Anness VII/mt 2632

9400464 ASPEGIC 500 POWDER 900MG IN SACHETS 9600061 ASPEGIC INJECTION 1G

8500070 ASPIREM ENTERIC COATED TABLETS 300MG 9500253 ASPIREM ENTERIC COATED TABLETS 75MG 9600145 ASS-RATIOPHARM TABLETS 100MG 9500741 ASTHENAL FILM COATED TABLETS 7800497 ATALINE TABLETS 5MG

7000366 ATARAX SYRUP 2MG/ML

7000364 ATARAX TABLETS 25MG

2100072 ATASOL FOR INFANTS DROPS 80MG/ML 2100073 ATASOL FORTE EXTRA STRENGTH TABLETS 500MG 9600360 ATEHEXAL COMP FILM COATED TABLETS 9400289 ATEHEXAL FILM COATED TABLETS 100MG 9400288 ATEHEXAL FILM COATED TABLETS 50MG 9400059 ATENOLOL GOLGI FILM COATED TABLETS 100MG 9900571 ATENOLOL TABLETS 25MG

9900572 ATENOLOL TABLETS 50MG

8800618 ATENOLOL-RATIOPHARM 100 FILM COATED TABLETS 100MG

7700498 ATENSIN TABLETS 40MG

8000317 ATENSIN TABLETS 80MG

9400346 ATGAM INJECTION 50MG/ML

8900619 ATHLETE'S FOOT POWDER 1%

9500002 ATHLETE'S FOOT SPRAY 1%

8400603 ATODEL TABLETS 1MG

8900462 ATODEL TABLETS 2MG

8900463 ATODEL TABLETS 5MG

7201459 ATROPINE EYE DROPS 1%

9600394 ATROPINE SULPHATE INJECTION 1MG/ML 8500491 ATROPINE SULPHATE INJECTION 1MG/ML, 1ML 9100027 ATROVENT INHALER 20MCG/METERED DOSE 9600289 ATROVENT SOLUTION FOR INHALATION 250MCG/2ML 8200095 AUGMENTIN FILM COATED TABLETS 375MG

AA2003/ACT/Anness VII/mt 2633

8900452 AUGMENTIN FILM COATED TABLETS 625MG 9700126 AUGMENTIN INFANT DROPS 62.5MG/ML 8600412 AUGMENTIN IV POWDER FOR INJECTION 1.2G 8600411 AUGMENTIN IV POWDER FOR INJECTION 600MG 8400556 AUGMENTIN POWDER FOR ORAL SUSP. 156MG/5ML 8900544 AUGMENTIN POWDER FOR ORAL SUSP. 312MG/5ML 9000551 AURORIX FILM COATED TABLETS 150MG 9900511 AVALOX TABLETS 400MG

9900119 AVANDIA TABLETS 1MG

9900120 AVANDIA TABLETS 2MG

9900121 AVANDIA TABLETS 4MG

9900122 AVANDIA TABLETS 8MG

8300488 AVANT TABLETS 1.5MG

8800552 AVANT TABLETS 20MG

7201226 AVEGON SUGAR COATED TABLETS

9900052 AVERNOL TABLETS 25MG

9900053 AVERNOL TABLETS 50MG

9900051 AVERNOL TABLETS 6.25MG

2000304 AVONEX POWDER FOR INJECTION 30MCG/ML, WITH SOLV IN SYRINGE

8300191 AXE BRAND UNIVERSAL OIL LIQUID 10ML 9400195 AXETINE POWDER FOR INJECTION 1.5G 9000501 AXETINE POWDER FOR INJECTION 750MG VIAL 8800604 AXID CAPSULES 150MG

8800605 AXID CAPSULES 300MG

9400479 AXID IV INJECTION 25MG/ML, 4ML AMP 2000439 AXSAIN CREAM 0.75% W/W

9700586 AZATHIOPRINE PCH POWDER FOR INJECTION 50MG 9700583 AZATHIOPRINE PCH TABLETS 50MG

9900235 AZATYL POWDER FOR INJECTION 1000MG WITH SOLVENT 9900236 AZATYL POWDER FOR INJECTION 1000MG WITH SOLVENT 9900233 AZATYL POWDER FOR INJECTION 2.000MG 9900213 AZELDERM CREAM 20%

AA2003/ACT/Anness VII/mt 2634

DOCSFORD

Treaty