1 September 2017 EMA/580096/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: terbutaline
Procedure no.: PSUSA/00002897/201612
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Aerodur® Turbohaler®
not available
13662.00.00
ASTRAZENECA GMBH
DE
not available
772081
ASTRAZENECA A/S
IS
not available
16.126
ASTRAZENECA OSTERREICH
AT
0,5 mg, Pulver zur Inhalation Bricanyl 0,3 mg/ml mixtúra, lausn Bricanyl 0,5 mg Ampullen
GMBH
Bricanyl 0,5 mg/ml
not available
14/143/72-C
ASTRAZENECA UK LIMITED
CZ
Bricanyl 0,5 mg/ml
not available
5617
ASTRAZENECA AS
NO
not available
OGYI-T-4167/02
ASTRAZENECA KFT.
HU
not available
711394 (IS)
ASTRAZENECA A/S
IS
Bricanyl 0.3 mg/ml Syrup
not available
PL 17901/0111
ASTRAZENECA UK LIMITED
UK
Bricanyl 2,5 mg/ml
not available
6769
ASTRAZENECA AS
NO
not available
RVG 15959
ASTRAZENECA BV
NL
injeksjonsvæske, oppløsning Bricanyl 0,5 mg/ml oldatos injekció Bricanyl 0,5 mg/ml stungulyf, lausn
inhalasjonsvæske til nebulisator, oppløsning Bricanyl 250 Turbuhaler, inhalatiepoeder 250 microgram/dosis List of nationally authorised medicinal products EMA/580096/2017
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Bricanyl 5 mg tabletter
not available
5618
ASTRAZENECA AS
NO
Bricanyl 5 mg tabletter
not available
8491
ASTRAZENECA AB
SE
Bricanyl 500
not available
AIC.023471030
ASTRAZENECA S.P.A.
IT
not available
PA 970/36/2
ASTRAZENECA UK LIMITED
IE
not available
RVG 12480
ASTRAZENECA BV
NL
not available
10017
ASTRAZENECA AB
SE
not available
9846
ASTRAZENECA AB
SE
not available
6791
ASTRAZENECA AS
NO
not available
NL 15 335
ASTRAZENECA S.A.S.
FR
mcg/erogazione polvere per inalazione Bricanyl 500 micrograms/ml solution for injection or infusion Bricanyl 500 Turbuhaler, inhalatiepoeder 500 microgram/dosis Bricanyl Depot 5 mg depottabletter Bricanyl Depot 7,5 mg depottabletter Bricanyl Depot 7,5 mg depottabletter. BRICANYL L.P. 5 mg, comprimé à libération prolongée
List of nationally authorised medicinal products EMA/580096/2017
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Bricanyl Retard 5 mg
not available
843549
ASTRAZENECA A/S
IS
not available
833178 (IS)
ASTRAZENECA A/S
IS
not available
10954
ASTRAZENECA A/S
DK
not available
10555
ASTRAZENECA A/S
DK
not available
1-19028
ASTRAZENECA OSTERREICH
AT
forðatöflur Bricanyl Retard 7,5 mg forðatöflur Bricanyl Retard, depottabletter BRICANYL RETARD, DEPOTTABLETTER Bricanyl Turbohaler 0,5 mg pro Dosis Pulver zur
GMBH
Inhalation Bricanyl Turbohaler, 500
not available
8525220
microgramas/dose, pó
ASTRAZENECA PRODUTOS
PT
FARMACEUTICOS LDA.
para inalação Bricanyl Turbohaler, 500
not available
5391479
microgramas/dose, pó
ASTRAZENECA PRODUTOS
PT
FARMACEUTICOS LDA.
para inalação Bricanyl Turbuhaler 0,25
not available
920079 (IS)
ASTRAZENECA A/S
IS
not available
7746
ASTRAZENECA AS
NO
mg/skammt innöndunarduft Bricanyl Turbuhaler 0,25mg/dose inhalasjonspulver
List of nationally authorised medicinal products EMA/580096/2017
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Bricanyl Turbuhaler 0,5
not available
870025
ASTRAZENECA A/S
IS
not available
7273
ASTRAZENECA AS
NO
not available
11495
ASTRAZENECA AB
SE
not available
10570
ASTRAZENECA AB
SE
not available
12829
ASTRAZENECA A/S
DK
not available
14925
ASTRAZENECA A/S
DK
not available
8489
ASTRAZENECA AB
SE
not available
9655
ASTRAZENECA AB
SE
not available
10603
ASTRAZENECA A/S
DK
mg/skammt innöndunarduft Bricanyl Turbuhaler 0,5mg/dose inhalasjonspulver Bricanyl Turbuhaler, 0,25 mg/dos inhalationspulver. Bricanyl Turbuhaler, 0,5 mg/dos inhalationspulver Bricanyl Turbuhaler, inhalationspulver Bricanyl Turbuhaler, inhalationspulver Bricanyl, 0,5 mg/ml, injektionsvätska/koncentr at till infusionsvätska, lösning Bricanyl, 2,5 mg/ml lösning för nebulisator, endosbehållare Bricanyl, inhalationsvæske til nebulisator, opløsning
List of nationally authorised medicinal products EMA/580096/2017
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Bricanyl,
not available
5600
ASTRAZENECA A/S
DK
not available
10479
ASTRAZENECA A/S
DK
Bricanyl, oral opløsning
not available
6029
ASTRAZENECA A/S
DK
Bricanyl® 0,5 mg
not available
6084327.00.00
ASTRAZENECA GMBH
DE
not available
NL 9094
ASTRAZENECA S.A.S.
FR
not available
NL 17 702
ASTRAZENECA S.A.S.
FR
not available
PL 17901/0112
ASTRAZENECA UK LIMITED
UK
not available
PL 17901/0114
ASTRAZENECA UK LIMITED
UK
not available
PL 17901/0116
ASTRAZENECA UK LIMITED
UK
injektionsvæske, opløsning Bricanyl, injektionsvæske, opløsning
Injektionslösung BRICANYL® 0,5 mg/1 ml, solution injectable en ampoule BRICANYL® 5 mg/2 ml, solution pour inhalation par nébuliseur en récipient unidose Bricanyl® Injection, 0.5 mg/ml, solution for injection or infusion Bricanyl® Respules® 2.5 mg/ml Nebuliser Solution Bricanyl® Tablets 5mg
List of nationally authorised medicinal products EMA/580096/2017
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Bricanyl® Turbohaler®
not available
PA 970/36/8
ASTRAZENECA UK LIMITED
IE
not available
PL 17901/0117
ASTRAZENECA UK LIMITED
UK
not available
10913
ASTRAZENECA OY
FI
not available
9960
ASTRAZENECA OY
FI
not available
NL 16 580
ASTRAZENECA S.A.S.
FR
not available
607.00.00
ASTRAZENECA GMBH
DE
not available
58.859
ASTRAZENECA
ES
500 micrograms per metered dose, inhalation powder Bricanyl® Turbohaler®, 0.5mg/dose, inhalation powder Bricanyl® Turbuhaler® 0,25 mg/annos inhalaatiojauheet Bricanyl® Turbuhaler® 0,5 mg/annos inhalaatiojauheet BRICANYL® TURBUHALER® 500 microgrammes/dose, poudre pour inhalation Bricanyl-Duriles® 7,5 mg, Retardtabletten TERBASMIN® TURBUHALER® 500
FARMACÉUTICA SPAIN, S.A.
microgramos polvo para inhalación
List of nationally authorised medicinal products EMA/580096/2017
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