| Code | 1684E | ||||||||||
| MA number | 21/0206/22-S | ||||||||||
| Product Form: | cps dur 100x300 mg (blis.PVC/PVDC/Al) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Reddy Holding GmbH, Germany | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 13.08.2022 |
| Validity: | 13.08.2027 |
| MA renewed: | Renewal application submitted |
| PIL: |
PIL_Pregabalin Reddy_08.2024.pdf
|
| SPC: |
SPC_Pregabalin Reddy_11.2024.pdf
|
| Safety feature | Yes |
| Data update: | 15.11.2024 |
