| Product Information |
|
| Registration Number |
BR-1093
|
| Generic Name |
Alteplase
|
| Brand Name |
Actilyse
|
| Dosage Strength |
50 mg
|
| Dosage Form |
Powder for Solution for Infusion (IV
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
Each box contains: Ph. Eur. Type I colourless glass vial
with bromobutyl rubber stopper and aluminium/ polypropylene, dark green flip-off seal + Type I glass vial (Sterile Water for Injection as diluent) x 50 mL
|
| Pharmacologic Category |
-
|
| Manufacturer |
Boehringer Ingelheim Pharma GmbH & Co. KG
|
| Country of Origin |
Germany
|
| Trader |
N/A
|
| Importer |
Boehringer Ingelheim (Philippines), Inc.
|
| Distributor |
Boehringer Ingelheim (Philippines), Inc.
|
| Application Type |
Initial (Variation)
|
| Issuance Date |
19 September 2022
|
| Expiry Date |
19 September 2027
|