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Product class:
|
Medicinal product with marketing authorization
|
|
Medicinal product class:
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Veterinary medicine
|
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Name of medicinal product:
|
Pergocoat
|
|
Active substances:
|
|
|
ATC code:
|
QN04BC02
|
|
Dosage form:
|
film-coated tablet
|
|
Strength:
|
0,5mg
|
|
Legal status for supply*:
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Subject to medicinal prescription
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|
Summary of product characteristics (SPC):
|
 (last updated April 14, 2023)
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|
Package information leaflet (PIL):
|
EST (last updated April 14, 2023)
|
|
Labelling:
|
(last updated April 14, 2023)
|
|
Indication:
|
Symptomatic treatment of clinical signs associated with Pituitary Pars Intermedia Dysfunction (PPID) (Equine Cushing’s Disease).
|
|
Safety features:
|
No
|
|
Marketing authorization holder:
|
Alfasan Nederland B.V.
|
|
Marketing authorization number:
|
2301
|
|
Marketing authorization issued on:
|
September 2, 2021
|
|
Marketing authorization expires on:
|
September 2, 2026
|
|
Marketing authorization procedure type:
|
Decentralised
|
|
Assessment report:
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|
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Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
|
1825376
|
Pergocoat
|
film-coated tablet
|
0,5mg 10TK
|
Prescription
|
|
|
|
|
|
|
1825387
|
Pergocoat
|
film-coated tablet
|
0,5mg 30TK
|
Prescription
|
|
|
|
|
|
|
1825398
|
Pergocoat
|
film-coated tablet
|
0,5mg 60TK
|
Prescription
|
|
|
|
|
|
|
1825400
|
Pergocoat
|
film-coated tablet
|
0,5mg 90TK
|
Prescription
|
|
|
|
|
|
|
1825411
|
Pergocoat
|
film-coated tablet
|
0,5mg 100TK
|
Prescription
|
|
|
|
|
|
|
1825422
|
Pergocoat
|
film-coated tablet
|
0,5mg 120TK
|
Prescription
|
|
|
|
|
|
|
1825433
|
Pergocoat
|
film-coated tablet
|
0,5mg 160TK
|
Prescription
|
|
|
|
|
|
|
1825444
|
Pergocoat
|
film-coated tablet
|
0,5mg 240TK
|
Prescription
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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