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Shire Plc's list of EU CTD Dossiers, Marketing Authorizations, In, Out Licensing Opportunities & Finished Dosage Formulations aggregated by PharmaCompass

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NEW RIVER

SHIRE

SHIRE DEV LLC

SHIRE DEVELOPMENT

SHIRE HUMAN GENETIC

SHIRE HUMAN GENETIC THERAPIES INC

SHIRE LLC

SHIRE ORPHAN THERAP

SHIRE ORPHAN THERAPIES LLC

SHIRE PHARMA CANADA ULC

Shire Australia Pty Limited

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ACETAMINOPHEN; BUTALBITAL; CAFFEINE

AGALSIDASE ALFA

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

ANAGRELIDE (ANAGRELIDE HYDROCHLORIDE)

ANAGRELIDE HYDROCHLORIDE

ANTI-INHIBITOR COAGULANT COMPLEX

ANTIHEMOPHILIC FACTOR (RECOMBINANT)

ANTIHEMOPHILIC FACTOR (RECOMBINANT) PORCINE SEQUENCE

ANTIHEMOPHILIC FACTOR (RECOMBINANT), PEGYLATED

ANTITHROMBIN III (HUMAN)

CARBAMAZEPINE

COAGULATION FACTOR IX (HUMAN)

DEXTROAMPHETAMINE SULFATE

DOXEPIN HYDROCHLORIDE

FURAZOLIDONE

GUANFACINE (GUANFACINE HYDROCHLORIDE)

GUANFACINE HYDROCHLORIDE

HISTRELIN ACETATE

HYDROFLUMETHIAZIDE

HYDROFLUMETHIAZIDE; RESERPINE

ICATIBANT (ICATIBANT ACETATE)

ICATIBANT ACETATE

IDURSULFASE

IMMUNOGLOBULIN (HUMAN)

IRON DEXTRAN

LANADELUMAB

LANTHANUM (LANTHANUM CARBONATE HYDRATE)

LANTHANUM CARBONATE

LEVODOPA

LISDEXAMFETAMINE DIMESYLATE

MESALAMINE

MESALAZINE

METHANTHELINE BROMIDE

MIDODRINE HYDROCHLORIDE

MIXED SALTS AMPHETAMINE

MORICIZINE HYDROCHLORIDE

NITROFURAZONE

NONACOG GAMMA

PROPANTHELINE BROMIDE

PRUCALOPRIDE SUCCINATE

TETRACYCLINE HYDROCHLORIDE

URACIL MUSTARD

VELAGLUCERASE ALFA

WATER

guanfacine

icatibant

lanthanum

lisdexamfetamine

mesalazine

teduglutide

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CAPSULE

CAPSULE (EXTENDED RELEASE)

CAPSULE, EXTENDED RELEASE;ORAL

CAPSULE;ORAL

CREAM;TOPICAL

FOR SOLUTION;TOPICAL

INJECTABLE; IV (INFUSION)

INJECTABLE;INJECTION

INJECTABLE;INTRAVENOUS

INJECTABLE;SUBCUTANEOUS

KIT

OINTMENT;TOPICAL

POWDER FOR SOLUTION

POWDER;INTRAVENOUS

POWDER;ORAL

POWDER;TOPICAL

SOLUTION

SUSPENSION;ORAL

TABLET (CHEWABLE)

TABLET (DELAYED AND EXTENDED RELEASE)

TABLET (EXTENDED-RELEASE)

TABLET, CHEWABLE;ORAL

TABLET, DELAYED RELEASE;ORAL

TABLET, EXTENDED RELEASE;ORAL

TABLET;ORAL

capsule

Blank

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0.20%

0.5MG

1.25MG;1.25MG;1.25MG;1.25MG

1.2G

1.2GM

10%

1000MG

1000UNIT/VIAL

100MG

10G/VIAL

10MG

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

10MG/ML

10MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

10MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1100UNIT/VIAL

12.5MG;12.5MG;12.5MG;12.5MG

1300UNIT/VIAL

1500UNIT/VIAL

15MG

15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

192ML/VIAL

1MG

1MG/ML

2.2MG/ML

2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

2.5MG;2.5MG;2.5MG;2.5MG

200 UNITS/VIAL

2000UNIT/VIAL

200MG

200MG/ML

20MG

250MG

250UNIT/VIAL

25MG

25MG;0.125MG

25MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

25MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

2MG

2MG/ML

3.125MG;3.125MG;3.125MG;3.125MG

3.75MG;3.75MG;3.75MG;3.75MG

30 mg

3000UNIT/VIAL

300MG

300MG/2ML

30MG

3250UNIT/VIAL

325MG;50MG;40MG

3MG

400 UNITS/VIAL

400UNIT/VIAL

40MG

4MG

50 mg

500MG

500UNIT/ML

500UNIT/VIAL

50MG

50MG/15ML

50MG;0.125MG

50MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

550UNIT/VIAL

5G/VIAL

5MG

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

5MG;5MG;5MG;5MG

6.25MG;6.25MG;6.25MG;6.25MG

60MG

6MG/3ML

7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

7.5MG;7.5MG;7.5MG;7.5MG

70 mg

70MG

720UNIT/5ML

750MG

9.375MG;9.375MG;9.375MG;9.375MG

96ML/VIAL

EQ 0.2MG BASE/ML

EQ 0.5MG BASE

EQ 0.5MG BASE/ML

EQ 100MG BASE

EQ 10MG BASE

EQ 150MG BASE

EQ 1GM BASE

EQ 1MG BASE

EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

EQ 1MG BASE/ML

EQ 250MG BASE

EQ 25MG BASE

EQ 2MG BASE

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

EQ 3MG BASE

EQ 4MG BASE

EQ 500MG BASE

EQ 50MG BASE

EQ 50MG IRON/ML

EQ 750MG BASE

EQ 75MG BASE

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AUSTRALIA

CANADA

USA

CAPSULE;ORAL
325MG;50MG;40MG
ANOQUAN
USA
87628
1986-10-01
DISCN
SOLUTION
1MG/ML
REPLAGAL
CANADA
2249057
3.5ML
Prescription
TABLET;ORAL
25MG;2MG **Federal Reg...
TRIAVIL 2-25
USA
14715
1982-01-01
DISCN
TABLET;ORAL
10MG;4MG **Federal Reg...
TRIAVIL 4-10
USA
14715
1982-01-01
DISCN
TABLET;ORAL
10MG;2MG **Federal Reg...
TRIAVIL 2-10
USA
14715
1982-01-01
DISCN
TABLET;ORAL
25MG;4MG **Federal Reg...
TRIAVIL 4-25
USA
14715
1982-01-01
DISCN
TABLET;ORAL
50MG;4MG **Federal Reg...
TRIAVIL 4-50
USA
14715
1982-01-01
DISCN
CAPSULE, EXTENDED RELE...
2.5MG;2.5MG;2.5MG;2.5M...
ADDERALL XR 10
USA
21303
2001-10-11
RX
CAPSULE, EXTENDED RELE...
5MG;5MG;5MG;5MG
ADDERALL XR 20
USA
21303
2001-10-11
RX
CAPSULE, EXTENDED RELE...
7.5MG;7.5MG;7.5MG;7.5M...
ADDERALL XR 30
USA
21303
2001-10-11
RX
CAPSULE, EXTENDED RELE...
6.25MG;6.25MG;6.25MG;6...
ADDERALL XR 25
USA
21303
2002-05-22
RX
CAPSULE, EXTENDED RELE...
1.25MG;1.25MG;1.25MG;1...
ADDERALL XR 5
USA
21303
2002-05-22
RX
CAPSULE, EXTENDED RELE...
3.75MG;3.75MG;3.75MG;3...
ADDERALL XR 15
USA
21303
2002-05-22
RX
CAPSULE, EXTENDED RELE...
3.125MG;3.125MG;3.125M...
MYDAYIS
USA
22063
2017-06-20
RX
CAPSULE, EXTENDED RELE...
6.25MG;6.25MG;6.25MG;6...
MYDAYIS
USA
22063
2017-06-20
RX
CAPSULE, EXTENDED RELE...
9.375MG;9.375MG;9.375M...
MYDAYIS
USA
22063
2017-06-20
RX
CAPSULE, EXTENDED RELE...
12.5MG;12.5MG;12.5MG;1...
MYDAYIS
USA
22063
2017-06-20
RX
CAPSULE
0.5MG
AGRYLIN
CANADA
2236859
100
Prescription
CAPSULE;ORAL
EQ 0.5MG BASE
AGRYLIN
USA
20333
1997-03-14
RX
CAPSULE;ORAL
EQ 1MG BASE **Federal ...
AGRYLIN
USA
20333
1997-03-14
DISCN
KIT
1300UNIT/VIAL
FEIBA NF
CANADA
2202581
20ML
Schedule D
KIT
3250UNIT/VIAL
FEIBA NF
CANADA
2353903
50ML
Schedule D
POWDER FOR SOLUTION
3000UNIT/VIAL
ADVATE
CANADA
2337193
3000IU
Schedule D
POWDER FOR SOLUTION
2000UNIT/VIAL
ADVATE
CANADA
2313111
5ML
Schedule D
POWDER FOR SOLUTION
250UNIT/VIAL
ADVATE
CANADA
2365944
2ML
Schedule D
POWDER FOR SOLUTION
500UNIT/VIAL
ADVATE
CANADA
2365952
2ML
Schedule D
POWDER FOR SOLUTION
1000UNIT/VIAL
ADVATE
CANADA
2284154
5ML VIAL
Schedule D
POWDER FOR SOLUTION
1500UNIT/VIAL
ADVATE
CANADA
2284162
5ML
Schedule D
POWDER FOR SOLUTION
500UNIT/ML
OBIZUR
CANADA
2447401
1ML RECONST. IN 3ML VIAL
Schedule D
KIT
1000UNIT/VIAL
ADYNOVATE
CANADA
2459051
5ML
Schedule D
KIT
250UNIT/VIAL
ADYNOVATE
CANADA
2459035
5ML
Schedule D
KIT
500UNIT/VIAL
ADYNOVATE
CANADA
2459043
5ML
Schedule D
KIT
2000UNIT/VIAL
ADYNOVATE
CANADA
2459078
5ML
Schedule D
KIT
1100UNIT/VIAL
ANTITHROMBIN III NF
CANADA
2237810
1 VIAL OF POWDER AND 20 ML VIAL OF WATER
Schedule D
KIT
550UNIT/VIAL
ANTITHROMBIN III NF
CANADA
2237811
1 VIAL OF POWDER AND 10 ML VIAL OF WATER
Schedule D
CAPSULE, EXTENDED RELE...
200MG
CARBATROL
USA
20712
1997-09-30
RX
CAPSULE, EXTENDED RELE...
300MG
CARBATROL
USA
20712
1997-09-30
RX
CAPSULE, EXTENDED RELE...
100MG
CARBATROL
USA
20712
1997-09-30
RX
POWDER FOR SOLUTION
720UNIT/5ML
IMMUNINE VH
CANADA
2206021
5ML
Schedule D
TABLET;ORAL
5MG **Federal Register...
DEXTROSTAT
USA
84051
1982-01-01
DISCN
TABLET;ORAL
10MG **Federal Registe...
DEXTROSTAT
USA
84051
1982-01-01
DISCN
CAPSULE;ORAL
EQ 10MG BASE
DOXEPIN HYDROCHLORIDE
USA
16987
1982-01-01
DISCN
CAPSULE;ORAL
EQ 25MG BASE
DOXEPIN HYDROCHLORIDE
USA
16987
1982-01-01
DISCN
CAPSULE;ORAL
EQ 50MG BASE
DOXEPIN HYDROCHLORIDE
USA
16987
1982-01-01
DISCN
CAPSULE;ORAL
EQ 100MG BASE
DOXEPIN HYDROCHLORIDE
USA
16987
1982-01-01
DISCN
CAPSULE;ORAL
EQ 75MG BASE
DOXEPIN HYDROCHLORIDE
USA
16987
1982-01-01
DISCN
CAPSULE;ORAL
EQ 150MG BASE
DOXEPIN HYDROCHLORIDE
USA
16987
1987-04-13
DISCN
TABLET;ORAL
100MG
FUROXONE
USA
11270
1982-01-01
DISCN
SUSPENSION;ORAL
50MG/15ML
FUROXONE
USA
11323
1982-01-01
DISCN
Intuniv
AUSTRALIA
28
Intuniv
AUSTRALIA
28
Intuniv
AUSTRALIA
28
Intuniv
AUSTRALIA
28
TABLET (EXTENDED-RELEA...
1MG
INTUNIV XR
CANADA
2409100
7/100
Prescription
TABLET (EXTENDED-RELEA...
2MG
INTUNIV XR
CANADA
2409119
7/100
Prescription
TABLET (EXTENDED-RELEA...
3MG
INTUNIV XR
CANADA
2409127
100
Prescription
TABLET (EXTENDED-RELEA...
4MG
INTUNIV XR
CANADA
2409135
100
Prescription
TABLET, EXTENDED RELEA...
EQ 1MG BASE
INTUNIV
USA
22037
2009-09-02
RX
TABLET, EXTENDED RELEA...
EQ 2MG BASE
INTUNIV
USA
22037
2009-09-02
RX
TABLET, EXTENDED RELEA...
EQ 3MG BASE
INTUNIV
USA
22037
2009-09-02
RX
TABLET, EXTENDED RELEA...
EQ 4MG BASE
INTUNIV
USA
22037
2009-09-02
RX
INJECTABLE;INJECTION
EQ 0.2MG BASE/ML
SUPPRELIN
USA
19836
1991-12-24
DISCN
INJECTABLE;INJECTION
EQ 0.5MG BASE/ML
SUPPRELIN
USA
19836
1991-12-24
DISCN
INJECTABLE;INJECTION
EQ 1MG BASE/ML
SUPPRELIN
USA
19836
1991-12-24
DISCN