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Product Information / Maklumat Produk
Product Name :

Spiolto Respimat Inhalation Solution 2.5mcg/2.5mcg per actuation

 Registration No :

MAL17075001AZ
Holder :

BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.

 Holder Address :

LEVEL 23A, MERCU ASPIRE NO. 3, JALAN BANGSAR KL ECO CITY,
59200
KUALA LUMPUR
MALAYSIA
Phone No :

60320920088
Manufacturer :

Boehringer Ingelheim Pharma GmbH & Co.KG

 Manufacturer Address :

BINGER STRASSE 173
INGELHEIM AM RHEIN
55216
GERMANY
Importer :

DKSH MALAYSIA SDN. BHD.

 Importer Address :

B-11-01, THE ASCENT, PARADIGM
NO. 1, JALAN SS7/26A, KELANA JAYA
47301
PETALING JAYA
MALAYSIA
Ingredients Information / Maklumat Bahan Aktif
No Active Ingredient
1 TIOTROPIUM BROMIDE MONOHYDRATE
2 olodaterol hydrochloride
 
Packaging Information / Maklumat Bungkusan
No Quantity
1 1units Units
2 1 respimat pro inhaler and 1 cartridge containing 4ml inhalation solution providing 60 puffs (30 medicinal doses) Units
3 1 cartridge (refill) containing 4ml inhalation solution providing 60 puffs (30 medicinal doses) Units
 
Label (mock-up) for Immediate Container / Label Dalam Bekas
No Attachment
1 Device back label_LAP048177-002 (clean).pdf
2 SPIOLTO Reusable_LABEL_Device front (Jan2021).pdf
3 SPIOLTO Reusable_LABEL_Cartridge (Nov2020).pdf
 
Label (mock-up) for Outer Carton / Label Luar Bekas
No Attachment
1 D2 Spiolto_Refill_FBP048193-003.pdf
2 D2 Spiolto_Device_FBP048173-003.pdf